genericlicensing.com - featured companies 2011

Global Generic

Product DirectoryFeatureD ComPanies

Edition 3, 2011

This is the 3rd ever edition of the

Global Generic Product DirectoryWe're really proud of this one. We've listened carefully to our community and made some changes. In this edition we have focused on presentingour recommended developers. Too much choice can be paralyzing; so you will now a FEATURED DEVELOPERS section at the front. We have alsoreplaced 25% of the developers for one's we consider better partners for your business.

Remember that you can find the contact details for all the listed developers online and its costs you nothing to make an enquiry.

:

Genericlicensing Limited has been set up to help you do more business, more effectively.We understand the industry is changing. We understand that you want to find new value-added products for new markets. During 2011 we willintroduce new data for: Biosimilars, Super Generics & Over-the-Counter

We want to be the first place you turn to when you think about a new productIn order to better support you and your business, we are working hard to introduce more services online. You can now ask us to post WANTEDproducts online so the developers can come to you! Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!)

The world of generics at your fingertips!

Asa CoxFounder, Genericlicensing [email protected] skype: asa_cox

Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy ofthe data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.

Find a productyou like in thedirectory

Go online towww.genericlicensing.com

Make contact with the developer

FEATURED DEVELOPERSlisted alphabetically

Antiobiotic ........................ 1

Astron ........................ 2 – 8

Aurobindo ........................ 9 – 13

BluePharma ........................ 14

Chanelle Medical ........................ 15 – 16

FamyCare Ltd. ........................ 17

Farmaprojects ........................ 18 – 20

Hikma ........................ 21 – 39

LogenexPharm ........................ 40

Lupin ........................ 41 – 44

Naari ........................ 45

Neogen ........................ 46

Orion ........................ 47

Rivopharm ........................ 48

Technimede ........................ 49 – 52

Wockhardt ........................ 53 – 59

Worwag ........................ 60

Contents

Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.

because timing is everythingWe target our goals.

target our drugs. time our delivery…

For more information please visit www.dexcel.com Contact: [email protected], [email protected]

Research:groups of patents.Development: Approximately 50 products registered; about 20 further in development.Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled manufacturing technology – including electronic batch recording.Quality: and

transfer and inventory coverage.Responsiveness: Global supply chain management services. Marketing/ Distribution: Major generic player in UK and Israel; fully geared up to win tenders in Germany. Presence in several more markets worldwide via distribution partners.

Interested in: Contract manufacturing Contract development/ Co-development Out-licencing In-licencing Distribution EU-re-analyses/ release

FEATUREDDEVELOPERS

1

FEATURED DEVELOPERS Global Generic Product directory


COUNTRYBulgaria

CITYRazgad

COMPANY NAMEAntibiotic

Antibiotic - Razgrad JSC, as the successor of the largest producer of antibiotics in Bulgaria. Balkanpharma-Razgrad JSC, has over 50 years experience in the development, production and sales of generic medicines for human and veterinary use. Antibiotic - Razgrad JSC is the majority owner of Balkanpharma-Razgrad JSC - a pharmaceutical plant with production units for finished dosage forms: capsules and tablets, semi-solid dosage forms, sterile liquid and dry injectable forms and also an industrial unit for lyophilized APIs. The portfolio of products covers various therapeutic areas with an accent on infectious diseases, ophthalmology and dermatology. Antibiotic - Razgrad JSC has the necessary manufacture licenses and EU GMP certification for all productions and currently exports to more than 25 countries in Europe and Asia. The development strategy of the company includes the implementation of modern technologies and new products elaborated by its own R&D activities and is oriented towards expanding sales in international markets. Apart from own market presence, the company is open to out-licensing and contract manufacturing projects.

Core Sales Territory: Eastern EuropeCore Operation: API Manufacture, Finished Dose Manufacture, Sales and MarketingContact Person: Ms Gergana Semova; Managing Director

MOLECULE NAME DOSE FORM DOSE STRENGTHDOSSIER FORMAT

DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Betamethasone + Gentamicin Cream 1 mg + 1 mg CTD Ready Bulgaria PLGBetamethasone + Gentamicin Ointment 1 mg + 1 mg CTD Ready Bulgaria PLGBetamethasone Valerate Cream 1 mg / g CTD Ready Bulgaria PLGBetamethasone Valerate Ointment 1 mg / g CTD Ready Bulgaria PLGDexamethasone Tablet 0.5 mg CTD Ready Bulgaria PLGFluconazole Injection - Solution 2 mg/ml - 50 ml, 100 ml CTD Ready Bulgaria PLGFluconazole Capsule 150 mg eCTD In-Dev BulgariaFluconazole Capsule 200 mg eCTD In-Dev BulgariaGentamicin Ointment - Eye 3 mg / g CTD Ready Bulgaria PLGHydrocortison + Chloramphenicol Ointment - Eye 5 mg/g + 2 mg/g CTD Ready Bulgaria PLGLevofloxacin Injection - Solution 5 mg/ml - 50 ml CTD Ready Bulgaria PLGLevofloxacin Injection - Solution 5 mg/ml - 100 ml CTD Ready Bulgaria PLGLevofloxacin Drops - Eye 5 mg/ml - 5 ml CTD Ready Bulgaria PLGMethylprednisolone Tablet 4 mg CTD Ready Bulgaria PLGMethylprednisolone Tablet 4 mg CTD Ready Bulgaria PLGPrednisolone Tablet 5 mg CTD Ready Bulgaria PLGPrednisone Tablet 5 mg CTD Ready Bulgaria PLGTobramycin Ointment - Eye 3 mg/g CTD Ready Bulgaria PLGTobramycin + Dexamethasone Ointment - Eye 3 mg/g + 1 mg/g CTD Ready Bulgaria PLG

FEATURED DEVELOPERSGlobal Generic Product directory

IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)2

COUNTRYIndia

CITYAhmedabad

COMPANY NAMEAstron Research Ltd

Astron Research Ltd was established in the year 2001 with an objective to provide prompt and reliable services to Pharma sector worldwide and improve the product quality with the help of Technological Innovations and Upgradations. Astron commenced its UK operations in 2004 for Quality Testing and QP Release of finished formulations and API. This facility is now UK-MHRA approved.Astron Research Ltd has products and technology are sold in over 50 countries, which includes European Union, US, Canada Austra-lia, New Zealand, South Africa, Brazil, Mexico, Middle East & North African countries. 18 ANDAs filed in US and 38 EU CTD dossiers developed till 2007. Astron Research Ltd is capable of handling Formulation and Analytical Research of Solid Orals, Injectables, Lyophilised injectables, Topicals, Effervescent tablets, Specialty medicaments like Potent drugs & Oncology products. The company has also acquired expertise in oral NDDS and Controlled Release pellets.Core Sales Territory: Global Regulated MarketsCore Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution Contact Person: Marc Comas, VP Business Development

Molecule name DOSE FORM DOSE STRENGTHDOSSIER FORMAT

DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Aceclofenac Tablet - Film coated 100 mg CTD Ready Spain PLG

Alendronate / Alendronic Acid Tablet 5 mg, 10 mg, 70 mg CTD Ready IOR PLG

Anastrozole Tablet - Film coated 1 mg ANDA Ready IOR NRP

Anastrozole Tablet - Film coated 1 mg CTD Ready IOR PLG

Aripiprazole Tablet - Dispersible (ODT) 5 mg, 10 mg, 15 mg, 30 mg CTD In-Dev N / A DCP slot booked

Aripiprazole Tablet - Dispersible (ODT) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg ANDA In-Dev N / A NRP

Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg CTD In-Dev N / A NRP

Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg ANDA In-Dev N / A NRP

Bicalutamide Tablet - Film coated 50 mg CTD Ready IOR PLG

Bicalutamide Tablet - Film coated 50 mg ANDA Ready IOR PLG

Bisoprolol Tablet 2.5 mg, 5 mg, 10 mg CTD In-Dev N / A DCP slot booked

Calcium Carbonate Tablet - Effervescent 500 mg CTD Ready IOR DCP underway

Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD In-Dev N / A NRP

Capecitabine Tablet - Film coated 150 mg, 500 mg CTD In-Dev N / A DCP slot booked

Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg CTD In-Dev N / A NRP

Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg ANDA In-Dev N / A NRP

Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) ANDA In-Dev N / A NRP

Carboplatin Injection 10 mg/ml (60 ml) CTD Ready IOR NRP

Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) CTD Ready IOR PLG

Cisplatin Injection - Solution 1 mg/ml (100 ml) CTD Ready IOR NRP


Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 3


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Cisplatin Injection - Solution 1 mg/ml (10 ml, 25 ml, 50 ml) CTD Ready IOR PLG

Clopidogrel Tablet 75 mg ANDA In-Dev N / A NRP

Clopidogrel Hydrogenbisulphat Tablet 75 mg CTD Ready IOR DCP underway

Clozapine Capsule - XR 25 mg, 50 mg, 100 mg, 200 mg CTD In-Dev N / A NRP

Cytarabine Injection 100 mg/ml (1 ml, 5 ml, 10 ml) CTD Ready IOR PLG

Darifenacin Tablet - SR 7.5 mg, 15 mg CTD In-Dev N / A NRP

Docetaxel Injection 40 mg/ml (0.5 ml, 2 ml) CTD Ready IOR DCP underway

Docetaxel Injection 40 mg/ml (0.2 ml, 0.8 ml) ANDA Ready IOR NRP

Donepezil Tablet 5 mg, 10 mg CTD Ready IOR PLG

Donepezil Tablet 5 mg, 10 mg ANDA Ready IOR NRP

Doxorubicin Injection - Solution 2 mg/ml (5 ml, 25 ml, 100 ml) CTD Ready UK PLG

Enoxaparin Injection - Pre-filled syringe150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, 1 ml

CTD In-Dev N / A NRP

Enoxaparin Injection - Pre-filled syringe150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, 1 ml

ANDA In-Dev N / A NRP

Epirubicin Injection - Solution 2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml) ANDA In-Dev N / A NRP

Epirubicin Injection - Solution 2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml) CTD Ready IOR PLG

Escitalopram Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR PLG

Etoposide Injection 20 mg/ml (12.5 ml, 25 ml) ANDA Ready IOR NRP

Exemestane Tablet 25 mg CTD Ready IOR PLG

Exemestane Tablet 25 mg ANDA In-Dev N / A NRP

Fesoterodine Tablet - SR 4 mg, 8 mg CTD In-Dev N / A NRP

Finasteride Tablet 1 mg CTD Ready IOR PLG


Finasteride Tablet 1 mg ANDA Ready IOR NRP

Finasteride Tablet 5 mg ANDA Ready IOR PLG

Fludarabine Injection 50 mg/ml (2ml) ANDA Ready IOR NRP

ASTRON RESEARCH LTD




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Fluorouracil (5FU) Injection 50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml) ANDA In-Dev N / A NRP

Fluorouracil (5FU) Injection 50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml) CTD Ready IOR PLG

Fluvastatin Tablet - SR 80 mg CTD In-Dev N / A DCP slot booked

Fluvastatin Tablet - SR 80 mg ANDA In-Dev N / A NRP

Gabapentin Tablet - Film coated 600 mg, 800 mg CTD Ready Finland PLG

Gemcitabine Injection - Ready-to-use 0.2 g, 1 g, 1.5 g, 2 g CTD In-Dev N / A DCP underway

Gemcitabine Injection - Powder 2000 mg CTD Ready IOR DCP slot booked

Gemcitabine Injection - Powder 200 mg, 1000 mg CTD Ready IOR PLG

Gemcitabine Injection - Powder 200 mg, 1000 mg, 2000 mg ANDA Ready IOR NRP

Glimepiride Tablet 1 mg, 2 mg, 3 mg, 4 mg CTD Ready IOR PLG

Glimepiride Tablet 1 mg, 2 mg, 4 mg ANDA Ready IOR PLG

Imatinib Tablet 100 mg, 400 mg CTD In-Dev N / A DCP slot booked

Irbesartan Tablet 75 mg, 150 mg, 300 mg CTD Ready IOR PLG

Irinotecan Injection 20 mg/ml (2 ml, 5 ml) CTD Ready IOR PLG

Irinotecan Injection 20 mg/ml (2 ml, 5 ml) ANDA In-Dev N / A NRP

Irinotecan Injection 20 mg/ml (25 ml) CTD Ready IOR NRP

Iron Sucrose Injection 20 mg/ml (5 ml vial) ANDA In-Dev N / A NRP

Lansoprazole Tablet - Enteric coated 15 mg, 30 mg CTD In-Dev N / A DCP slot booked

Lansoprazole Capsule - SR 15 mg, 30 mg ANDA In-Dev N / A NRP

Letrozole Tablet - Film coated 2.5 mg CTD Ready IOR PLG

Letrozole Tablet - Film coated 2.5 mg ANDA Ready IOR PLG

Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready IOR DCP slot booked

Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg ANDA Ready N / A Approved

Levodopa + Carbidopa Tablet 100 mg + 25 mg, 200 mg + 50 mg CTD Ready N / A DCP underway

Levodopa + Carbidopa Tablet 100 mg + 25 mg, 200 mg + 50 mg ANDA In-Dev N / A NRP

Levofloxacin Tablet 250 mg, 500 mg CTD Ready N / A DCP underway

Levothyroxine Tablet 25/50/75/88/100/112/125/137/150/175/200/300 µg CTD In-Dev N / A NRP

ASTRON RESEARCH LTD




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Levothyroxine Tablet 25/50/75/88/100/112/125/137/150/175/200/300 µg ANDA In-Dev N / A NRP

Losartan Potassium Tablet - Film coated 25 mg, 50 mg, 100 mg CTD Ready IOR PLG

Meloxicam Injection 5 mg/ml (10 ml) ANDA Ready IOR NRP

Methotrexate Injection 5 mg/ml (3 ml) CTD Ready Sweden PLG

Methotrexate Injection 25 mg/ml (2ml) CTD Ready IOR NRP

Methotrexate Injection 100 mg/ml (5 ml, 10 ml) CTD Ready IOR NRP

Methotrexate Injection 5 mg/ml (3 ml) ANDA In-Dev N / A NRP

Methotrexate Injection 25 mg/ml (2ml) ANDA In-Dev N / A NRP

Methotrexate Injection 100 mg/ml (5 ml, 10 ml) ANDA In-Dev N / A NRP

Methotrexate Injection 25 mg/ml (20 ml. 40 ml) CTD Ready IOR NRP

Metoprolol Succinate Tablet - SR 25 mg, 50 mg, 100 mg, 200 mg ANDA Ready IOR NRP

Midazolam Injection 1 mg/ml (5 ml) CTD Ready IOR PLG

Midazolam Injection 5 mg/ml (1 ml, 3 ml, 10 ml) CTD Ready IOR PLG

Mitomycin Injection - Powder 5 mg, 20 mg, 40 mg ANDA Ready IOR PLG

Mitomycin Injection - Powder 0.2 mg/vial ANDA In-Dev N / A NRP

Mitoxantrone Injection 2 mg/ml (10 ml, 12.5 ml, 15 ml) ANDA In-Dev N / A NRP

Montelukast Tablet - Chewable 4 mg, 5 mg CTD Ready Europe PLG

Montelukast Tablet - Film coated 10 mg CTD In-Dev N / A DCP underway

Montelukast Tablet - Film coated 10 mg ANDA In-Dev N / A NRP

Mycophenelate Mofetil Injection - Powder 500 mg CTD In-Dev N / A DCP underway

Mycophenelate Mofetil Capsule - Hard gel 250 mg ANDA Ready IOR PLG

Mycophenelate Mofetil Capsule - Hard gel 250 mg CTD Ready IOR PLG

Mycophenelate Mofetil Tablet - Film coated 500 mg CTD Ready IOR PLG

Mycophenelate Mofetil Tablet - Film coated 500 mg ANDA Ready IOR PLG

Naltrexone Tablet 50 mg CTD Ready UK PLG

Naltrexone Tablet 50 mg ANDA Ready IOR NRP

Olanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg CTD Ready IOR DCP underway

ASTRON RESEARCH LTD




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Olanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg ANDA In-Dev N / A NRP

Olmasertan Tablet 5 mg, 10 mg, 20 mg, 40 mg CTD In-Dev N / A DCP slot booked

Omeprazole Capsule 20 mg, 40 mg CTD In-Dev N / A DCP slot booked

Ondansetron Injection 2 mg/ml (2 ml, 4 ml) CTD Ready IOR PLG

Ondansetron Injection 2 mg/ml (2 ml, 4 ml) ANDA In-Dev N / A NRP

Orlistat Capsule 60 mg CTD In-Dev N / A NRP

Oxaliplatin Injection - Powder 50 mg, 100 mg CTD Ready IOR PLG

Oxaliplatin Injection - Ready-to-use 50 mg, 100 mg CTD Ready IOR PLG

Oxaliplatin Injection - Ready-to-use 5 mg/ml (10 ml, 20 ml, 40 ml) ANDA In-Dev N / A NRP

Oxaliplatin Injection - Ready-to-use 200 mg CTD Ready IOR NRP

Oxcarbazepine Capsule - XR 300 mg, 600 mg CTD In-Dev N / A NRP

Oxybutynin Tablet - SR 5 mg, 10 mg, 15 mg CTD In-Dev N / A NRP

Paclitaxel Injection - Solution 6 mg/ml (5 ml, 16.7 ml, 50 ml) CTD Ready IOR DCP underway

Paclitaxel Injection - Solution 6 mg/ml (5 ml, 16.7 ml, 50 ml) ANDA Ready IOR NRP

Paliperidone Tablet - SR 1.5 mg, 3 mg, 6 mg, 9 mg ANDA In-Dev N / A NRP

Pantoprazole Sodium Tablet - Enteric coated 20 mg, 40 mg CTD In-Dev N / A DCP slot booked

Pantoprazole Sodium Tablet - SR 20 mg, 40 mg ANDA In-Dev N / A NRP

Paracetamol Tablet - Effervescent 500 mg, 1000 mg CTD Ready IOR PLG

Pemetrexed Injection - Powder 100 mg, 500 mg CTD In-Dev N / A DCP slot booked

Pioglitazone Tablet 15 mg, 30 mg, 45 mg CTD Ready IOR DCP slot booked

Pioglitazone Tablet 15 mg, 30 mg, 45 mg ANDA Ready IOR NRP

Pramipexole Tablet 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg CTD In-Dev N / A NRP

Pramipexole Tablet 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg ANDA In-Dev N / A NRP

Pravastatin Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR PLG

Pravastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg ANDA In-Dev N / A NRP

Pregabalin Capsule25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg

CTD In-Dev N / A NRP

ASTRON RESEARCH LTD




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Quetiapine Tablet - SR 200 mg, 300 mg, 400 mg CTD Ready IOR DCP underway

Quetiapine Tablet - IR 25 mg, 100 mg, 150 mg, 200 mg, 300 mg CTD Ready IOR DCP underway

Quetiapine Tablet - SR 50 mg CTD In-Dev N / A DCP slot booked

Quetiapine Tablet - IR 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg ANDA In-Dev N / A NRP

Quetiapine Tablet - SR 150 mg, 200 mg, 300 mg, 400 mg ANDA Ready IOR NRP

Quetiapine Tablet - SR 50 mg ANDA In-Dev N / A NRP

Quinine Sulphate Tablet 300 mg CTD Ready IOR NRP

Rabeprazole Tablet 10 mg, 20 mg CTD In-Dev N / A DCP slot booked

Ramipril Tablet 1.25 mg, 2.5 mg, 5 mg, 10 mg CTD In-Dev N / A DCP underway

Ranitidine Tablet - Effervescent 150 mg, 300 mg CTD Ready IOR PLG

Ranitidine Tablet - Effervescent 75 mg CTD In-Dev N / A NRP

Rasagiline Tablet 1 mg CTD In-Dev N / A NRP

Repaglinide Tablet 0.5 mg, 1 mg, 2 mg CTD In-Dev N / A DCP slot booked

Risperidone Tablet - Film coated 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg CTD Ready IOR PLG

Ropinirole Tablet - Film coated 0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg CTD Ready IOR PLG

Sildenafil Tablet 25 mg, 50 mg, 100 mg CTD Ready IOR DCP underway

Simvastatin Tablet - Film coated 10 mg, 20 mg, 40 mg, 80 mg ANDA Ready IOR PLG

Sirolimus Tablet 1 mg, 2 mg CTD In-Dev N / A DCP slot booked

Sodium Valproate Tablet - SR 300 mg, 500 mg CTD In-Dev N / A NRP

Solifenacin succinate Tablet - Film coated 5 mg, 10 mg CTD In-Dev N / A DCP slot booked

Sumatriptan Succinate Tablet 50 mg, 100 mg CTD Ready Finland PLG

Tacrolimus Capsule - Hard gel 0.5 mg, 1 mg, 5 mg CTD Ready IOR DCP underway

Tacrolimus Capsule - Hard gel 0.5 mg, 1 mg, 5 mg ANDA Ready IOR NRP

Tacrolimus Ointment 0.01%, 0.03% CTD In-Dev N / A NRP

Tadalafil Tablet 2.5 mg, 5 mg, 10 mg, 20 mg CTD In-Dev N / A DCP slot booked

Telmisartan Tablet 20 mg, 40 mg, 80 mg CTD In-Dev N / A DCP slot booked

Telmisartan + HCTZ Tablet 40 mg + 12.5 mg, 80 mg + 12.5 mg CTD In-Dev N / A NRP

ASTRON RESEARCH LTD




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Temozolomide Capsule - Hard gel 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg CTD Ready IOR NRP

Temozolomide Capsule - Hard gel 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg ANDA Ready IOR NRP

Terazosin Tablet 1 mg, 2 mg, 5 mg, 10 mg CTD Ready IOR PLG

Tolterodine Capsule - XR 2 mg, 4 mg CTD In-Dev N / A DCP slot booked

Tolterodine Capsule - SR 4 mg ANDA In-Dev N / A NRP

Tolterodine Tablet - IR 1 mg, 2 mg CTD Ready IOR PLG

Topiramate Tablet 25 mg, 50 mg, 100 mg, 200 mg CTD Ready IOR PLG

Topotecan Injection - Powder 4 mg CTD Ready IOR PLG

Topotecan Injection - Ready-to-use 4 mg CTD In-Dev N / A NRP

Vardenafil Tablet - Film coated 5 mg, 10 mg, 20 mg CTD In-Dev N / A NRP

Vitamin C Tablet - Effervescent 500 mg CTD In-Dev N / A NRP

Voriconazole Tablet 50/200 mg CTD In-Dev N / A NRP

Warfarin Tablet1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, 10 mg

CTD In-Dev N / A DCP slot booked

Warfarin Tablet1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, 10 mg

ANDA Ready IOR NRP

Ziprasidone Capsule 20 mg, 40 mg, 60 mg, 80 mg CTD In-Dev N / A NRP

ASTRON RESEARCH LTD

9


IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)

COMPANY NAMEAurobindo

COUNTRYIndia

CITYHyderabad

Aurobindo Pharma was born of a vision. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardiovascular, gastroenterology, etc. Over the years, the Au-robindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country manufacturing facilities, and is becoming a marketing conglomerate across the world. Aurobindo Pharma created a name for itself in the manufacture of bulk actives, its area of core competence. The formulation busi-ness is systematically organized with a divisional structure, and has a focused team for each key international market. Aurobindo believes in gaining volume and market share in every business/segment it enters. Core Sales Territory: Global Regulated MarketsCore Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, DistributionContact Person: Mr Vivek Shah; Business Support Manager


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Alendronate sodium Tablet 10, 70 mg; CTD Ready IOR IOR

Alendronate sodium + Cholecalciferol Tablet 70mg+2800IU, 70mg+5600IU CTD Ready IOR IOR

Alfuzosin HCl Tablet - XR 10 mg CTD Ready IOR IOR

Alfuzosin HCl Tablet 2.5mg CTD Ready IOR IOR

Alprazolam Tablet 0.25,0.5,1mg CTD Ready IOR IOR

Amisulpride Tablet 50, 100, 200, 400mg CTD Ready IOR IOR

Amlodipine Tablet 5&10 mg; CTD Ready IOR IOR

Amlodipine Capsule 5,10mg CTD Ready IOR IOR

Amoxicillin Capsule 250,500mg CTD Ready IOR IOR

Amoxicillin Tablet 1G CTD Ready IOR IOR

Amoxicillin + Clavulanic Acid PFOS 125+31.25, 250+62.5 mg: Sugar free CTD Ready IOR IOR

Azithromycin Suspension - Oral 200mg/5ml, 500mg/5ml* CTD Ready IOR IOR

Azithromycin Tablet 250/500/600mg CTD Ready IOR IOR

Benazepril Tablet 5, 10, 20mg CTD Ready IOR IOR

Betahistine Tablet 8,16,24mg CTD Ready IOR IOR

Bisoprolol Fumarate Tablet 1.25,2.5,3.75,5mg CTD Ready IOR IOR

Carvedilol Tablet 3.125,6.25,12.5,25mg CTD Ready IOR IOR

Cefixime Suspension - Oral 100mg/5ml CTD Ready IOR IOR

Cefixime Tablet 200,400mg CTD Ready IOR IOR

AUROBINDO PHARMA

10




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Cefpodoxime Proxetil Suspension - Oral 40mg/5ml CTD Ready IOR IOR

Cefpodoxime Proxetil Tablet 100, 200mg CTD Ready IOR IOR

Cefprozil PFOS 125, 250mg/5ml CTD Ready IOR IOR

Cefprozil Tablet 250, 500mg CTD Ready IOR IOR

Cefuroxime Axetil Tablet 250,500mg; UK, PL 125 mg CTD Ready IOR IOR

Cephalexin Capsule 250,500mg CTD Ready IOR IOR

Cetirizine HCl Tablet 10 mg CTD Ready IOR IOR

Ciprofloxacin HCl Tablet 250,500,750mg CTD Ready IOR IOR

Citalopram HBr Tablet 10,20,40 mg CTD Ready IOR IOR

Clarithromycin Tablet 250,500mg CTD Ready IOR IOR

Clindamycin HCl Capsule 150, 300 mg CTD Ready IOR IOR

Cloxacillin Capsule 250, 500mg CTD Ready IOR IOR

Didanosine Capsule - EC 200250400 CTD Ready IOR IOR

Doxazosin Mesylate Tablet 1,2,4,8mg CTD Ready IOR IOR

Enalapril Maleate Tablet 5, 10, 20mg CTD Ready IOR IOR

Esomeprazole Magnesium Tablet - DR 20,40mg CTD Ready IOR IOR

Finasteride Tablet 5mg CTD Ready IOR IOR

Finasteride Tablet 1mg CTD Ready IOR IOR

Fluconazole Suspension - Oral 50, 200 mg / 5ml, CTD Ready IOR IOR

Fluconazole Capsule 50,100,150,200mg CTD Ready IOR IOR

Fluoxetine HCl Solution - Oral 20mg/5ml CTD Ready IOR IOR

Fluoxetine HCl Capsule 10, 20, 40, 60mg CTD Ready IOR IOR

Fosinopril + HCTZ Tablet 20+12.5mg CTD Ready IOR IOR

Fosinopril Sodium Tablet 10, 20 mg CTD Ready IOR IOR

Furosemide Tablet 20, 40mg CTD Ready IOR IOR

Gabapentin Capsule 100,300,400mg CTD Ready IOR IOR

Gabapentin Tablet 600,800mg; CTD Ready IOR IOR

AUROBINDO PHARMA

11




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Glimepiride Tablet 1,2,3,4mg CTD Ready IOR IOR

Lamotrigine Tablet 25, 50, 100, 200 mg CTD Ready IOR IOR

Lamotrigine Tablet - Chewable 2, 5, 25, 50, 100, 200mg CTD Ready IOR IOR

Lansoprazole Capsule - DR 15,30mg CTD Ready IOR IOR

Lansoprazole Tablet - Dispersible (ODT) 15, 30 mg CTD Ready IOR IOR

Levetiracetam Solution - Oral 100mg/ml CTD Ready IOR IOR

Levetiracetam Tablet 250,500,750mg, 1g CTD Ready IOR IOR

Lisinopril Tablet 5, 10, 20, 30, 40 mg CTD Ready IOR IOR

Lisinopril + HCTZ Tablet 10+12.5,20+12.5mg CTD Ready IOR IOR

Losartan Potassium Tablet 12.5, 25, 50, 100mg CTD Ready IOR IOR

Losartan Potassium + HCTZ Tablet 50+12.5, 100+25mg CTD Ready IOR IOR

Meloxicam Tablet 7.5,15mg CTD Ready IOR IOR

Metformin HCl Tablet 500,850,1000mg CTD Ready IOR IOR

Metoprolol Tartrate Tablet 50,100 & 200MG CTD Ready IOR IOR

Mirtazapine Tablet - Dispersible (ODT) : 15, 30, 45mg CTD Ready IOR IOR

Mirtazapine Plain Tablet 15,30,45mg CTD Ready IOR IOR

Modafinil Tablet 100 mg CTD Ready IOR IOR

Moxifloxacin HCl Tablet 400mg CTD Ready IOR IOR

Naproxen Tablet 250, 500mg CTD Ready IOR IOR

Naproxen Sodium Tablet 550mg CTD Ready IOR IOR

Nevirapine TFOS 50 mg PEPFAR PED CTD Ready IOR IOR

Nevirapine Tablet 200mg CTD Ready IOR IOR

Nitrofurantoin Capsule 100mg (75mg MH + 25 Mcryst) CTD Ready IOR IOR

Olanzapine Tablet 2.5, 5, 7.5, 10, 15, 20 mg CTD Ready IOR IOR

Olanzapine Tablet - Dispersible (ODT) 5,10,15,20 mg CTD Ready IOR IOR

Omeprazole Pellet - DR 10,20,40mg CTD Ready IOR IOR

Ondansetron Tablet - Dispersible (ODT) 4,8mg CTD Ready IOR IOR

AUROBINDO PHARMA

12




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Ondansetron HCl Tablet 4,8 mg CTD Ready IOR IOR

Pantoprazole sodium Tablet - DR 20,40mg CTD Ready IOR IOR

Paroxetine HCl Tablet 20,30mg CTD Ready IOR IOR

Pen V potassium Tablet 250, 800, 1000mg, 1.0 m.u, 1.5m.u CTD Ready IOR IOR

Perindopril Erbumine Tablet 2,4,8mg CTD Ready IOR IOR

Phenytoin Sodium Tablet EU: 50,100mg CTD Ready IOR IOR

Pioglitazone Tablet 15,30,45mg CTD Ready IOR IOR

Pramipexole Tablet 0.125, 0.25, 0.5, 1, 1.5 mg CTD Ready IOR IOR

Pravastatin Tablet 10, 20, 40mg CTD Ready IOR IOR

Quinapril HCl Tablet 5,10,20,40mg CTD Ready IOR IOR

Quinapril HCl + HTZ Tablet 10+12.5, 20+12.5, 20+25 mg CTD Ready IOR IOR

Ramipril Capsule 1.25,2.5,5,10mg: CTD Ready IOR IOR

Ramipril Tablet 1.25, 2.5, 5,10mg; CTD Ready IOR IOR

Ranitidine HCl Syrup 15mg/1ml CTD Ready IOR IOR

Repaglinide Tablet 0.5, 1, 2 mg CTD Ready IOR IOR

Ribavirin Capsule 200mg CTD Ready IOR IOR

Ribavirin Tablet 200, 400mg CTD Ready IOR IOR

Risedronate Tablet 5, 30, 35mg CTD Ready IOR IOR

Risedronate Sodium+Calcium carbonate

Tablet 35+500mg; CTD Ready IOR IOR

Risperidone Tablet 0.5,1,2,3,4,6mg, CTD Ready IOR IOR

Risperidone Solution - Oral 1mg/ml CTD Ready IOR IOR

Rizatriptan Tablet 5, 10mg CTD Ready IOR IOR

Rizatriptan Tablet - Dispersible (ODT) 5, 10mg CTD Ready IOR IOR

Ropinirole Tablet 0.25,0.5,1,2,5 mg CTD Ready IOR IOR

Rosuvastatin Ca Tablet 5, 10, 20, 40mg CTD Ready IOR IOR

Sertraline HCl Tablet 50,100mg CTD Ready IOR IOR

AUROBINDO PHARMA

13




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Sertraline HCl Tablet 50,100mg CTD Ready IOR IOR

Sertraline HCl Capsule 25,50,100mg CTD Ready IOR IOR

Simvastatin Tablet 5,10,20,30,40,60,80mg; CTD Ready IOR IOR

Sotalol Tablet 40, 80, 160mg CTD Ready IOR IOR

Sumatriptan Succinate Tablet 50,100 mg; CTD Ready IOR IOR

Tamsulosin HCl Capsule 0.4mg CTD Ready IOR IOR

Terbinafine Tablet 125, 250mg CTD Ready IOR IOR

Topiramate Tablet 25,50,100,200mg CTD Ready IOR IOR

Torsemide Tablet 5,10mg CTD Ready IOR IOR

Tramadol HCl Capsule 50 mg CTD Ready IOR IOR

Tramadol HCl + Acetaminophen Tablet 37.5+325 mg CTD Ready IOR IOR

Trandolapril Capsule 0.5,1,2, 4mg CTD Ready IOR IOR

Ursodiol Tablet 150, 250, 300, 400, 450, 500mg | CTD Ready IOR IOR

Ursodiol Capsule 150, 200, 250, 300mg CTD Ready IOR IOR

Valacyclovir Tablet 500,1000 mg; CTD Ready IOR IOR

Venlafaxine HCl Tablet 25,37.5,50,75mg CTD Ready IOR IOR

Venlafaxine HCl Capsule - XR 37.5, 75, 150mg CTD Ready IOR IOR

Zidovudine Capsule 100, 250mg CTD Ready IOR IOR

Zolpidem Tartrate Tablet 5,10mg CTD Ready IOR IOR

AUROBINDO PHARMA

14



COUNTRYPortugal

CITYCoimbra

COMPANY NAMEBluepharma

Bluepharma is a privately owned pharmaceutical company, based in Portugal. The main activities of the company include development, manufacturing and marketing of generic products for human use. Bluepharma has human resources and dedicated facilities allocated to R&D activities, covering formulation, development and validation of analytical methods, scale-up, manufacturing of pilot batches, stability studies and regulatory affairs. Our company is approved for the manufacturing and packaging of human investigational medicinal products. Starting in 2010 Bluepharma has the capacities to develop oncology products. The manufacturing site of the company exhibits a modern layout and is equipped with state of the art equipment for the manufacturing of solid dosage forms. We account for a significant track record of successful developments, as well as for innumerous partnerships with top players in the pharmaceutical industry worldwide, including USA.

Core Sales Territory: Global Regulated MarketsCore Operation: Sales and Marketing, Finished Dose Manufacture, DistributionContact Person: Mr. André Garnel Freitas; Head of Business Development


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Acarbose Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG

Aripiprazole Tablet 5 mg, 10 mg, 15 mg, 20 mg, 30 mg CTD Ready N / A NRP

Atorvastatin Tablet - Film coated 10 mg, 20 mg, 40 mg, 80 mg CTD Ready Portugal IOR

Azithromycin Tablet - Film coated 500 mg CTD Ready Portugal PLG

Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD Ready Portugal PLG

Candesartan + HCTZ Tablet 8 mg + 12.5 mg, 16 mg + 12.5 mg CTD Ready Portugal PLG

Clarithromycin Tablet - Film coated 250 mg, 500 mg CTD Ready Portugal PLG

Clopidogrel Besylate Tablet 75 mg CTD Ready N / A IOR

Ibandronate / Ibandronic Acid Tablet - Film coated 50 mg, 150 mg CTD Ready N / A IOR

Irbesartan Tablet - Film coated 75 mg, 150 mg, 300 mg CTD Ready N / A DCP underway

Irbesartan + HCTZ Tablet - Film coated150 mg + 12.5 mg, 300 mg + 12.5 mg, 300 mg + 25 mg

CTD Ready N / A DCP underway

Levetiracetam Solution - Oral 100 mg/ml CTD Ready Portugal PLG

Levetiracetam Tablet - Film coated 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready Portugal PLG

Losartan Tablet - Film coated 12.5 mg, 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG

Losartan + HCTZ Tablet - Film coated 50 mg + 12.5 mg, 100 mg + 25 mg CTD Ready Portugal PLG

Nicorandil Tablet 10 mg, 20 mg CTD Ready Portugal PLG

Nimesulide Tablet 100 mg CTD Ready Portugal PLG

Pramipexole Tablet - Film coated 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg CTD Ready Portugal NRP

Propiverine Tablet - Film coated 5 mg, 15 mg CTD Ready Portugal PLG



COUNTRYIreland

CITYLoughrea

COMPANY NAMEChanelle

The Chanelle Group was established in 1983 as a distributor of animal health products and is now the largest veterinary pharma-ceutical manufacturer and distributor in Ireland. It diversified in 1980 into the development and manufacture of veterinary generic pharmaceutical products and is also a major player in the pet care market. A further diversification in 1995 with Chanelle Medical been established as a developer & manufacturer of medical generic products. Chanelle Medical are a one-stop-shop where we offer; formulation development, method development & validation, pilot batches, stability studies, monitoring of BE studies, compilation of dossier, registration of dossier, sale of dossier, manufacture and packing finish product. This company has approximately 900 generic product licenses (both Vet & Med) granted to date in 80 countries. The Group is privately owned, has a turnover of €60m, 220 employees with it’s head office in Loughrea, Co. Galway and offices in UK, France & Jordan. Core Sales Territory: Western EuropeCore Operation: Sales and Marketing, Finished Dose ManufactureContact Person: Mrs. Chanelle McCoy; Director of Medical Business


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Alkamed (Gaviscon) Solution - Oral 0.5% CTD Ready Ireland PLG

Amlodipine Capsule 5 mg, 10 mg CTD Ready Ireland PLG

Amorolfine Nail Lacquer 5% CTD Ready Ireland DCP underway

Atenolol Solution - Oral 25 mg / 5 ml CTD Ready Ireland PLG

Bisacodyl Tablet 5 mg CTD Ready Ireland PLG

Bisoprolol Tablet 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg CTD Ready Ireland PLG

Cefaclor Capsule 250 mg, 500 mg CTD Ready Ireland PLG

Cetirizine Solution - Oral 1 mg/ml CTD Ready Ireland PLG

Cetirizine Tablet 10 mg CTD Ready Ireland PLG

Citalopram Tablet 10 mg, 20 mg, 40 mg CTD Ready Ireland PLG

Clindamycin Capsule 75 mg, 150 mg, 300 mg CTD Ready Ireland PLG

Doxycycline Capsule 50 mg, 100 mg CTD Ready Ireland PLG

Escitalopram Solution - Oral 20 mg/ml CTD Ready N / ADCP slot booked (Dec 2011)

Exemestane Tablet 25 mg CTD Ready Ireland DCP underway

Fexofenadine Tablet 120 mg, 180 mg CTD Ready Ireland PLG

Frovatriptan Tablet 2.5 mg CTD In-Dev N / ADCP slot booked (Dec 2011)

Glibenclamide Tablet 1.25 mg, 2.5 mg, 5 mg CTD Ready Ireland PLG

Glucosamine Sulphate Tablet - Film coated 500 mg (3x daily), 750 mg (2x daily), 1000 mg (1x daily) CTD Ready Ireland PLG




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Lacidipine Tablet 4 mg, 6 mg CTD In-Dev N / A NRP

Macrogol (Movicol) Sachet 6.86g, 13.72g CTD Ready N / A DCP underway

Meloxicam Tablet 7.5 mg, 15 mg CTD Ready Ireland PLG

Memantine Solution - Oral 10 mg/ml CTD In-Dev N / A DCP slot booked

Metronidazole Tablet 200 mg, 400 mg CTD Ready Ireland PLG

Mirtazapine Tablet - Dispersible (ODT) 15 mg, 30 mg, 45 mg CTD Ready Ireland PLG

Naratriptan Tablet 2.5 mg CTD Ready N / A DCP underway

Olanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg CTD Ready Ireland PLG

Paroxetine Hemihydrate Tablet 20 mg, 30 mg CTD Ready Ireland PLG

Riluzole Tablet 50 mg CTD In-Dev N / ADCP slot booked (Febr 2012)

Risperidone Solution - Oral 1 mg/ml CTD Ready Ireland PLG

Roxithromycin Tablet 150 mg CTD Ready Ireland PLG

Sodium Bicarbonate Capsule 500 mg CTD Ready Ireland PLG

Sumatriptan Succinate Tablet 50 mg, 100 mg CTD Ready Ireland PLG

Zonisamide Capsule 25 mg, 50 mg, 100 mg CTD In-Dev N / A NRP

CHANELLE MEDICAL

54



COUNTRYIndia

CITYMaharashtra

COMPANY NAMEFamycare

Famy Care Ltd, was established in 1987 with a vision to become a key player in the Family Planning & Women’s Healthcare. Today, we are a leading manufacturer of Oral Contraceptive Pills, contraceptive injectables, Intrauterine Devices and Condoms in a short span of time. Famy Care has been very active in Regulated market such as US, EU and South Africa. We have filed more than 20 ANDAs with the USFDA in less than 18 months which highlights our technical competence and capabilities. In Semi-Regulated markets, we have attained a pan global leadership status within the contraceptive segment .We export to more than 60 countries in Asia, Latin America and Africa. We work closely with various leading international bodies like UNFPA, IPPF, PSI etc to bring high quality, afford-able contraceptives in the markets that need them the most.

Core Sales Territory: Global Non Regulated MarketsCore Operation: Finished Dose Manufacture, Sales and MarketingContact Person: Mr Ashutosh Dharmadhikari; Business Development


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Chlormadinone + EE Tablet 2mg+0.03mg eCTD In-Dev N / A DCP slot booked

Desogestrel Tablet 0.075mg eCTD In-Dev N / A DCP slot booked

Desogestrel + EE Tablet 0.15mg+0.03mg eCTD Ready India DCP underway

Desogestrel + EE Tablet 0.15mg+0.02mg eCTD Ready India DCP underway

Dienogest + EE Tablet 2mg+0.03mg eCTD In-Dev N / A DCP slot booked

Drospirenone + EE Tablet 3mg+0.02mg eCTD In-Dev N / A NRP

Drospirenone + EE Tablet 3mg+0.03mg eCTD In-Dev N / A NRP

Gestodene + EE Tablet 0.06mg+0.015mg eCTD In-Dev N / A DCP slot booked



Levonorgestrel Tablet 1.5 mg eCTD In-Dev N / A NRP

Levonorgestrel + EE Tablet 0.15mg+0.03mg eCTD Ready India PLG

Levonorgestrel + EE Tablet 0.10mg+0.02mg eCTD Ready India DCP underway

Medroxyprogesterone Acetate Injection 150mg/1ml eCTD In-Dev N / A NRP

Mifepristone Tablet 200 mg eCTD In-Dev N / A NRP

Norgestimate + EE Tablet 0.25mg+0.035mg eCTD Ready India DCP slot booked

18



COUNTRYSpain

CITYBarcelona

COMPANY NAMEFarmaprojects

Farmaprojects S.A. has 23 years of experience in development, registration and supply of generic drug products to third parties. Farmaprojects bases its out-licensing activities around the four key areas of: ensuring a top quality dossier, giving expert IP advice, regulatory affairs and registration support and pricing support throughout the product life cycle.Farmaprojects has also recently become an exclusive partner for commercialization through out-licensing agreements of all Polpharma products in European markets, thus significantly increasing its product portfolio and development pipeline. Our mission: Your success is what matters to us - An MAA dossier that exceeds the strictest standards of today’s pharmaceutical markets.

Core Sales Territory: Global Regulated MarketCore Operation: API Manufacture, API Manufacture, Finished Dose Manufacture, Finished Dose Manufacture, Sales and Market-ing, Sales and Marketing, DistributionContact Person: Tomasz Pawliszewski; International Business Development Manager


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Aciclovir Tablet 200mg – 400mg – 800mg eCTD Ready IOR

Alendronate/Alendronic Acid Tablet 70mg eCTD Ready IOR

Bicalutamide Tablet - Film coated 50mg - 150 mg eCTD Ready IOR

Bimatoprost Drops - Eye 0,3 mg/ml eCTD In-Dev N / A

Candesartan Tablet 4mg - 8mg - 16mg - 32mg eCTD Ready IOR

Candesartan + HCTZ Tablet 8mg/12,5mg – 16mg/12,5mg eCTD In-Dev N / A

Ciprofloxacin Tablet 250mg – 500mg eCTD Ready IOR

Citalopram Solution - Oral 40mg/ml eCTD Ready IOR

Citalopram Injection - Solution 20mg/0,5ml - 40mg/1ml eCTD Ready IOR

Citalopram Tablet - Film coated 10mg - 20mg - 30mg - 40 mg eCTD Ready IOR

Clarithromycin Powder - Infusion 500mg eCTD Ready IOR

Desloratadine Tablet - Film coated 5mg eCTD In-Dev N / ADCP Slot: February 2011

Desloratadine Solution - Oral 0,5mg/ml eCTD In-Dev N / ADCP Slot: February 2011

Dorzolamide Drops - Eye 20mg/ml eCTD Ready IOR

Dorzolamide + Timolol Drops - Eye 20mg+5mg/ml eCTD Ready IOR

Doxylamine Tablet 15mg - 25mg eCTD Ready IOR

Enalapril Tablet 5mg – 10mg – 20mg eCTD In-Dev N / A

Enalapril Tablet 5mg – 10mg – 20mg eCTD Ready IOR

19




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Enalapril + HCTZ Tablet 20mg/12,5mg eCTD Ready IOR

Eplerenone Tablet 25mg - 50mg eCTD Ready IOR

Escitalopram Tablet - Film coated 5mg - 10mg- 15mg - 20mg eCTD Ready IOR

Esomeprazole Powder - Infusion 40mg eCTD Ready IOR

Fenspiride Tablet 80mg eCTD Ready IOR

Gabapentin Capsule - Hard gel 100mg - 300mg - 400mg eCTD Ready IOR

Ibuprofen Suspension - Oral 100mg/ 5ml eCTD Ready IOR

Imatinib Tablet 100mg – 400mg eCTD In-Dev N / ADCP Slot: November 2011

Indapamide Tablet - SR 1,5mg eCTD Ready IOR

Irbesartan Tablet - Film coated 75mg – 150mg – 300mg eCTD Ready IOR

Irbesartan + HCTZ Tablet - Film coated 150mg/12,5mg - 300mg/12,5mg - 300mg/25mg eCTD Ready IOR

Levetiracetam Tablet 250mg - 500mg - 750mg - 1000mg eCTD Ready IOR

Levetiracetam Injection - Solution 100mg/ml eCTD Ready IOR

Levetiracetam Solution - Oral 100mg/ml eCTD Ready IOR

Levofloxacin Injection - Solution 250mg/50ml – 500mg/100ml eCTD Ready IOR

Levofloxacin Tablet - Film coated 250mg – 500mg eCTD Ready IOR

Linezolid Injection - Solution 2mg/ml eCTD In-Dev N / A

Losartan Tablet - Film coated 12,5mg - 25mg - 50mg – 100mg eCTD Ready IOR

Losartan + HCTZ Tablet - Film coated 50mg/12,5mg – 100mg/25mg eCTD Ready IOR

Meloxicam Injection - Solution 15mg/1,5ml eCTD Ready IOR

Memantine Tablet - Film coated 10mg – 20 mg eCTD In-Dev N / A

Memantine Drops - Oral 10mg/g eCTD In-Dev N / A

Metoprolol Succinate Tablet - SR 23,75mg - 47,5mg - 95mg - 190mg eCTD Ready IOR

Montelukast Sodium Tablet - Film coated 10mg eCTD Ready IOR

Montelukast Sodium Tablet - Chewable 4mg - 5mg eCTD Ready IOR

Montelukast Sodium Sachet 4mg eCTD In-Dev N / A DCP Slot: July 2011

FARMAPROJECTS

20




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Moxifloxacin Drops - Eye 15mg/3ml eCTD Ready IOR

Olanzapine Tablet 2,5mg - 5mg - 7,5mg - 10mg - 15mg - 20mg eCTD Ready IOR

Olanzapine Tablet - Dispersible (ODT) 5mg - 10mg - 15mg - 20mg eCTD Ready IOR

Olopatadine Drops - Eye 0.10% eCTD In-Dev N / A

Omeprazole Powder - Infusion 40mg eCTD Ready IOR

Ondansetron Injection - Solution 4mg/2ml - 8mg/4ml eCTD Ready IOR

Ondansetron Tablet - Dispersible (ODT) 4mg - 8mg eCTD Ready IOR

Opipramol HCl Tablet - Film coated 50mg eCTD Ready IOR

Orlistat Capsule 60mg - 120mg eCTD Ready IOR

Pantoprazol Injection - Lyophilisate for solution

40mg eCTD Ready IOR

Perindopril Tablet 4mg - 8mg eCTD Ready IOR

Piracetam Tablet - Film coated 800mg – 1200mg eCTD Ready IOR

Quetiapine Tablet - Film coated 25mg – 100mg – 150mg – 200mg 300mg eCTD Ready IOR

Rosuvastatin Tablet - Film coated 5mg – 10mg – 20mg – 40mg eCTD Ready IOR

Sildenafil Tablet 25mg – 50 mg – 100mg eCTD Ready IOR

Simethicone Drops - Oral 66mg/66ml eCTD Ready IOR

Simvastatin Tablet - Film coated 10mg – 20mg – 40mg – 80mg eCTD Ready IOR

Sumatriptan Tablet - Film coated 50mg, 100mg eCTD Ready IOR

Tianeptine Tablet - Film coated 12,5mg eCTD In-Dev N / ADCP Slot: March 2011

Topiramate Tablet 25mg – 50mg – 100mg – 200mg eCTD Ready IOR

Tramadol + Paracetamol Tablet - Film coated 37,5mg/ 325mg eCTD Ready IOR

Travoprost Drops - Eye 0,04mg/ml eCTD In-Dev N / A

Valsartan Tablet - Film coated 40mg – 80mg – 160mg – 320mg eCTD Ready IOR

Valsartan + HCTZ Tablet - Film coated 80/12,5mg - 160/12,5mg 160/25mg eCTD Ready IOR

Venlafaxine Tablet 25mg - 37,5mg - 50mg –75mg eCTD Ready IOR

Venlafaxine Capsule - PR 37,5mg - 75mg - 150mg eCTD Ready IOR

FARMAPROJECTS

21



COUNTRYJordan

CITYAmman

COMPANY NAMEHikma

Operations structured in three Business Units: Injectables, Generics and Branded Generics. Manufacturing operations established among 15 manufacturing sites in MENA, Western Europe and USA all 100% owned by Hikma.

Core Sales Territory: Middle East and North Africa, Regulated MarketCore Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, DistributionContact Person: Mr. Eyad Hylooz; Business development and Allianze Manager


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Acarbose Tablet 50 mg CTD Ready IOR PLG

Acarbose Tablet 100 mg CTD Ready IOR PLG

Acetylsalicylic Acid Tablet 100 mg CTD Ready IOR PLG

Aciclovir Tablet 200 mg CTD Ready IOR PLG



Aciclovir Injection 250 mg CTD Ready IOR PLG

Alendronate / Alendronic Acid Tablet 5 mg CTD Ready IOR PLG



Allopurinol Tablet 100 mg CTD Ready IOR PLG

Allopurinol Tablet 300 mg CTD Ready IOR PLG

Alprazolam Tablet 0.25 mg CTD Ready IOR PLG

Alprazolam Tablet 0.5 mg CTD Ready IOR PLG

Alprazolam Tablet 1 mg CTD Ready IOR PLG

Alprazolam Tablet 2 mg CTD Ready IOR PLG

Aluminium Hydroxide + Magnesium Carbonate + Magnesium Hydroxide

Tablet 282 mg, 85 mg CTD Ready IOR PLG

Amikacin Injection 100 mg/ 2 ml CTD Ready IOR PLG

22




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Amikacin Injection 500 mg/ 2 ml CTD Ready IOR PLG

Amiodarone Injection 150 mg/ 3 ml CTD Ready IOR PLG

Amiodarone Injection 150 mg/ 3 ml ANDA Ready IOR PLG

Amlodipine Tablet 2.5 mg CTD Ready IOR PLG

Amlodipine Tablet 5 mg CTD Ready IOR PLG

Amlodipine Capsule 5 mg CTD Ready IOR PLG

Amlodipine Tablet 10 mg CTD Ready IOR PLG

Amlodipine + Valsartan Tablet 5 mg, 160 mg CTD Ready IOR PLG

Amoxicillin Capsule 250 mg CTD Ready IOR PLG

Amoxicillin Capsule 500 mg CTD Ready IOR PLG

Amoxicillin Tablet 1 g CTD Ready IOR PLG

Amoxicillin Syrup 125 mg/ 5 ml CTD Ready IOR PLG

Amoxicillin Syrup 250 mg/ 5 ml CTD Ready IOR PLG

Amoxicillin Drops 100 mg/ ml CTD Ready IOR PLG

Amoxicillin + Clavulanic Acid Tablet 875 mg, 125 mg CTD Ready IOR PLG

Amoxicillin + Clavulanic Acid Syrup 125 mg, 31.25 mg/ 5 ml CTD Ready IOR PLG


Amoxicillin + Clavulanic Acid Solution - Oral 600 mg, 42.9 mg/ 5 ml CTD Ready IOR PLG

Amoxicillin + Clavulanic Acid Injection 500 mg, 100 mg CTD Ready IOR PLG

Amoxicillin + Clavulanic Acid Injection 1000 mg, 200 mg CTD Ready IOR PLG




Amoxicillin + Clavulanic Acid Solution - Oral 400 mg, 57 mg/ 5 ml CTD Ready IOR PLG

Anusol - generic Suppository 59 mg, 24 mg, 49 mg, 296 mg CTD Ready IOR PLG

Anusol - generic Topical 2.25 g, 0.875 g, 1.875 g, 10.75 g CTD Ready IOR PLG

Aripiprazole Tablet 10 mg CTD Ready IOR PLG

HIKMA

23




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Aripiprazole Tablet 15 mg CTD Ready IOR PLG

Ascorbic Acid Capsule 250 mg CTD Ready IOR PLG

Ascorbic Acid Capsule 500 mg CTD Ready IOR PLG

Atenolol Tablet 50 mg CTD Ready IOR PLG

Atenolol Tablet 100 mg CTD Ready IOR PLG

Atenolol + Chlortalidone Tablet 100 mg CTD Ready IOR PLG

Atorvastatin Tablet 10 mg CTD Ready IOR PLG




Atracurium Besylate Injection 25 mg/ 2.5 ml CTD Ready IOR PLG

Atracurium Besylate Injection 50 mg/ 5 ml CTD Ready IOR PLG

Atropine Injection 0.6 mg/ 1 ml CTD Ready IOR PLG

Azithromycin Capsule 250 mg CTD Ready IOR PLG

Azithromycin Capsule 500 mg CTD Ready IOR PLG

Azithromycin Tablet 500 mg CTD Ready IOR PLG

Azithromycin Syrup 100 mg/ 5 ml CTD Ready IOR PLG

Azithromycin Syrup 200 mg/ 5 ml CTD Ready IOR PLG

Azithromycin Solution - Oral 300 mg/ 7.5 ml CTD Ready IOR PLG

Azithromycin Injection 500 mg CTD Ready IOR PLG

Benzatropine mesylate Injection 1 mg/ ml ANDA Ready IOR PLG

Benzhexol Hydrochloride Tablet 2 mg CTD Ready IOR PLG

Benzhexol Hydrochloride Tablet 5 mg CTD Ready IOR PLG

Betamethasone + Gentamicin + Tolnaphtate + Clioquionol

Topical 0.5 mg, 1 mg, 10 mg, 10 mg/ g CTD Ready IOR PLG

Betamethasone + Neomycin Topical 1 mg, 5 mg/ g CTD Ready IOR PLG

Betamethasone Valerate Topical 1.25 mg/ g CTD Ready IOR PLG

HIKMA

24




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Bisacodyl Tablet 5 mg CTD Ready IOR PLG

Bisacodyl Suppository 5 mg CTD Ready IOR PLG

Bisacodyl Suppository 10 mg CTD Ready IOR PLG

Bismuth Subgallate, Bismuth oxide, Balsam peru, Zinc oxide

Suppository 59 mg, 24 mg, 49 mg, 296 mg CTD Ready IOR PLG

Bismuth Subgallate, Bismuth oxide, Balsam peru, Zinc oxide

Topical 2.25 g, 0.875 g, 1.875 g, 10.75 g CTD Ready IOR PLG

Bisoprolol + HCTZ Tablet 2.5 mg, 6.25 mg CTD Ready IOR PLG

Bisoprolol + HCTZ Tablet 5 mg, 6.25 mg CTD Ready IOR PLG

Bisoprolol + HCTZ Tablet 5 mg, 12.5 mg CTD Ready IOR PLG

Bisoprolol Fumarate Tablet 2.5 mg CTD Ready IOR PLG

Bisoprolol Fumarate Tablet 5 mg CTD Ready IOR PLG

Bisoprolol Fumarate Tablet 10 mg CTD Ready IOR PLG

Bromhexine Syrup 4 mg/ 5 ml CTD Ready IOR PLG

Bromocriptine Tablet 2.5 mg CTD Ready IOR PLG

Buflomedil HCl Tablet 150 mg CTD Ready IOR PLG

Bupivacaine Injection 0.25% (vials) CTD Ready IOR PLG

Bupivacaine Injection 0.50 % (vials) CTD Ready IOR PLG

Butorphanol tartrate Injection 1 mg/ ml ANDA Ready IOR PLG

Butorphanol tartrate Injection 2 mg/ ml ANDA Ready IOR PLG

Butorphanol tartrate Injection 20 mg/ 10 ml ANDA Ready IOR PLG

Calcipotriol Topical 0.05 mg/ g CTD Ready IOR PLG

Calcipotriol + Betametasone Dipropionate

Topical 0.05 mg, 0.5 mg/ g CTD Ready IOR PLG

Calcium Carbonate, Magnesium Hydroxide, Zinc Gluconate, Vitamin D3

Syrup375 mg (eq. to 150 mg Calcium), 180 mg (eq. to 75 mg magnesium), 21 mg (eq. to 3 mg zinc), 75 IU/ 5 ml

CTD Ready IOR PLG

Calcium Levulinate, Vitamin D3, Vitamin B12

Syrup 50 mg, 1000 IU, 10 mcg/ 5 ml CTD Ready IOR PLG

HIKMA

25




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Carboplatin Injection 50 mg/ 5 ml (Vials) CTD Ready IOR PLG

Carboplatin Injection 150 mg/ 15 ml CTD Ready IOR PLG



Carvedilol Tablet 3.125 mg CTD Ready IOR PLG



Carvedilol Tablet 25 mg CTD Ready IOR PLG

Cefaclor Syrup 125 mg/ 5 ml CTD Ready IOR PLG

Cefaclor Syrup 250 mg/ 5 ml CTD Ready IOR PLG

Cefaclor Capsule 250 mg CTD Ready IOR PLG

Cefaclor Capsule 500 mg CTD Ready IOR PLG

Cefadroxil Capsule 500 mg CTD Ready IOR PLG

Cefadroxil Syrup 250 mg/ 5 ml CTD Ready IOR PLG

Cefadroxil Solution - Oral 500 mg/ 5 ml CTD Ready IOR PLG

Cefalexin Capsule 250 mg CTD Ready IOR PLG

Cefalexin Capsule 500 mg CTD Ready IOR PLG

Cefalexin Syrup 125 mg/ 5 ml CTD Ready IOR PLG

Cefalexin Syrup 250 mg/ 5 ml CTD Ready IOR PLG

Cefazolin Injection 500 mg (vials) ANDA Ready IOR PLG

Cefazolin Injection 1 g (vials) CTD Ready IOR PLG

Cefazolin Injection 1 g (vials) ANDA Ready IOR PLG

Cefazolin Granules 2 g (vials) CTD Ready IOR PLG

Cefazolin Injection 10 g (vials) ANDA Ready IOR PLG

Cefixime Capsule 200 mg CTD Ready IOR PLG

Cefixime Capsule 400 mg CTD Ready IOR PLG

Cefixime Syrup 100 mg/ 5 ml CTD Ready IOR PLG

HIKMA

26




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Cefotaxime Injection 500 mg (vials) ANDA Ready IOR PLG

Cefotaxime Injection 1 g (vials) ANDA Ready IOR PLG



Cefoxitin Injection 1 g (vials) ANDA Ready IOR PLG

Cefradine Capsule 250 mg CTD Ready IOR PLG

Cefradine Capsule 500 mg CTD Ready IOR PLG

Ceftriaxone Injection 250 mg CTD Ready IOR PLG

Ceftriaxone Injection 250 mg ANDA Ready IOR PLG

Ceftriaxone Injection 500 mg CTD Ready IOR PLG

Ceftriaxone Injection 500 mg ANDA Ready IOR PLG

Ceftriaxone Injection 1 g CTD Ready IOR PLG

Ceftriaxone Injection 1 g ANDA Ready IOR PLG

Ceftriaxone Injection 2 g CTD Ready IOR PLG

Ceftriaxone Injection 2 g ANDA Ready IOR PLG

Cefuroxime Axetil Tablet 250 mg (Tablets) CTD Ready IOR PLG

Cefuroxime Axetil Tablet 500 mg (Tablets) CTD Ready IOR PLG

Cefuroxime Sodium Injection 750 mg CTD Ready IOR PLG

Cefuroxime Sodium Injection 750 mg ANDA Ready IOR PLG

Cefuroxime Sodium Injection 1.5 g CTD Ready IOR PLG

Cefuroxime Sodium Injection 1.5 g ANDA Ready IOR PLG

Cefuroxime Sodium Injection 7.5 g ANDA Ready IOR PLG

Cetirizine Dihydrochloride Tablet 10 mg CTD Ready IOR PLG

Chlordiazepoxide + Clidinium bromide Tablet 5 mg, 2.5 mg CTD Ready IOR PLG

Chlorphenamine Maleate + Caffeine Anhydrous + Paracetamol + Phenylephrine

Tablet 2 mg, 65 mg, 300 mg, 10 mg CTD Ready IOR PLG

HIKMA

27




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Chlorphenamine Maleate Syrup 2.5 mg/ 5 ml CTD Ready IOR PLG

Chlorphenamine Maleate Tablet 4 mg CTD Ready IOR PLG

Chlorphenamine Maleate Injection 10 mg/ 1 ml CTD Ready IOR PLG

Chlorzoxazone + Paracetamol Capsule 250 mg, 300 mg CTD Ready IOR PLG

Cilostazol Tablet 50 mg CTD Ready IOR PLG

Cilostazol Tablet 100 mg CTD Ready IOR PLG

Ciprofloxacin Tablet 250 mg CTD Ready IOR PLG



Ciprofloxacin Injection 2 mg/ ml CTD Ready IOR PLG

Ciprofloxacin Injection 2 mg/ ml ANDA Ready IOR PLG

Ciprofloxacin Injection 10 mg/ ml ANDA Ready IOR PLG

Citalopram Tablet 20 mg CTD Ready IOR PLG

Citalopram Tablet 40 mg CTD Ready IOR PLG

Clarithromycin Tablet 250 mg CTD Ready IOR PLG

Clarithromycin Tablet 500 mg CTD Ready IOR PLG

Clindamycin Phosphate Injection 300 mg/ 2 ml CTD In-Dev N / A IOR

Clindamycin Phosphate Injection 600 mg/ 4 ml CTD In-Dev N / A IOR

Clopidogrel Tablet 75 mg CTD Ready IOR PLG

Codeine phosphate + Chlorphenamine + Guaifenesin + Potassium Citrate + Sodium Benzoate + Liquid Extract of Liquorice

Syrup7.5 mg, 2.5 mg, 100 mg, 300 mg, 300 mg, 750 mg/ 10 ml

CTD Ready IOR PLG

Deferoxamine Mesylate Injection 500 mg (vials) CTD Ready IOR PLG

Desloratadine Syrup 0.5 mg/ 1 ml CTD Ready IOR PLG

Dexamethasone Sodium Phosphate Injection 4 mg/ ml CTD Ready IOR PLG

Dextromethorphan HBr Syrup 15 mg/ 5 ml CTD Ready IOR PLG

HIKMA

28




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Dextromethorphan HBr + Pseudoephedrine HCl + Chlorphenamine Maleate + Guaifenesin

Syrup 10 mg, 30 mg, 1.25 mg, 50 mg/ 5 ml CTD Ready IOR PLG

Diazepam Injection 10 mg/ 2 ml CTD Ready IOR PLG

Diclofenac Potassium Powder 50 mg CTD Ready IOR PLG

Diclofenac Potassium Tablet 50 mg CTD Ready IOR PLG

Diclofenac Sodium Tablet 25 mg (EC Tablets) CTD Ready IOR PLG

Diclofenac Sodium Suppository 25 mg CTD Ready IOR PLG


Diclofenac Sodium Tablet 50 mg (EC Tablets) CTD Ready IOR PLG

Diclofenac Sodium Tablet 75 mg (SR Tablets) CTD Ready IOR PLG


Diclofenac Sodium Capsule 100 mg CTD Ready IOR PLG



Diclofenac Sodium Suppository 12.5 mg CTD Ready IOR PLG

Diclofenac Sodium Topical 10 mg/ 1 g (Gel, Emulgel) CTD Ready IOR PLG

Diclofenac Sodium Topical 1 % (TGEL) CTD Ready IOR PLG

Diclofenac Sodium Injection 75 mg/ 3 ml CTD Ready IOR PLG

Dill seed oil, Sodium bicarbonate Syrup 2.3 mg, 52.5 mg/ 5 ml CTD Ready IOR PLG

Diosmin + Hesperidin Tablet 450 mg, 50 mg CTD Ready IOR PLG

Dipyridamole Tablet 75 mg CTD Ready IOR PLG

Doxazosin Tablet 1 mg CTD Ready IOR PLG

Doxazosin Tablet 4 mg CTD Ready IOR PLG

Doxycycline Hyclate Capsule 50 mg CTD Ready IOR PLG

Doxycycline Hyclate Capsule 100 mg CTD Ready IOR PLG

Enalapril Injection 1.25 mg/ ml ANDA Ready IOR PLG

HIKMA

29




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Ephedrine HCl, Chlorphenamine Maleate, Guaifenesin, Potassium Citrate, Sodium Benzoate, Liquid Extract of Liquorice

Syrup10 mg, 2.5 mg, 100 mg, 300 mg, 300 mg, 750 mg/ 10 ml

CTD Ready IOR PLG

Epinephrine Injection 1 mg/ ml ANDA Ready IOR PLG

Epirubicin HCl Injection 10 mg/ 5 ml CTD Ready IOR PLG

Epirubicin HCl Granules 50 mg/ 25 ml CTD Ready IOR PLG

Epirubicin HCl Injection 200 mg/ 100 ml CTD Ready IOR PLG

Erythromycin Syrup 125 mg/ 5 ml CTD Ready IOR PLG

Erythromycin Syrup 200 mg/ 5 ml CTD Ready IOR PLG

Erythromycin Solution - Oral 400 mg/ 5 ml CTD Ready IOR PLG

Erythromycin Tablet 250 mg CTD Ready IOR PLG

Erythromycin Tablet 500 mg CTD Ready IOR PLG

Escitalopram Tablet 5 mg (Tablets) CTD Ready IOR PLG



Esmolol Injection 2.5 mg/ 10 ml CTD Ready IOR PLG

Famotidine Tablet 10 mg CTD Ready IOR PLG



Fexofenadine HCl Tablet 120 mg CTD Ready IOR PLG

Fexofenadine HCl Tablet 180 mg CTD Ready IOR PLG


Fluconazole Capsule 50 mg CTD Ready IOR PLG

Fluconazole Capsule 150 mg CTD Ready IOR PLG

Fluconazole Injection 2 mg/ ml CTD Ready IOR PLG

Fluconazole Injection 2 mg/ ml ANDA Ready IOR PLG

Flumazenil Injection 0.1 mg/ ml CTD Ready IOR PLG

HIKMA

30




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Flumazenil Injection 0.1 mg/ ml ANDA Ready IOR PLG

Fluoxetine Capsule 20 mg CTD Ready IOR PLG

Flutamide Capsule 250 mg (Capsules) CTD Ready IOR PLG

Folic Acid (Vitamin B9) Tablet 5 mg CTD Ready IOR PLG

Folic acid + Ferrous Sulphate Tablet 0.5 mg, 150 mg CTD Ready IOR PLG

Folic acid + Ferrous Sulphate + Zinc Oxide

Tablet 0.5 mg, 150 mg, 61.8 mg CTD Ready IOR PLG

Folinic Acid Injection 10 mg/ ml (Vials) CTD Ready IOR PLG

Fosphenytoin Sodium Injection 75 mg/ ml ANDA Ready IOR PLG

Furosemide Tablet 40 mg CTD Ready IOR PLG

Furosemide Injection 20 mg/ 2 ml CTD Ready IOR PLG

Fusidic Acid Topical 20 mg/ g CTD Ready IOR PLG

Fusidic Acid + Betamethasone Valerate Topical 20 mg, 1 mg/ g CTD Ready IOR PLG

Gabapentin Capsule 100 mg CTD Ready IOR PLG



Gemcitabine Injection 1 g (Vials) CTD Ready IOR PLG

Gemcitabine Injection 200 mg (Vials) CTD Ready IOR PLG

Gemfibrozil Tablet 600 mg CTD Ready IOR PLG

Gentamicin Sulphate Injection 10 mg/ ml (vials) CTD Ready IOR PLG

Gentamicin Sulphate Injection 40 mg/ ml (vials) CTD Ready IOR PLG

Glibenclamide Tablet 5 mg CTD Ready IOR PLG

Glimepiride Tablet 1 mg CTD Ready IOR PLG






HIKMA

31




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Granisetron Injection 1 mg/ 1 ml CTD Ready IOR PLG

Granisetron Injection 1 mg/ 1 ml ANDA Ready IOR PLG

Granisetron Injection 3 mg/ 3 ml CTD Ready IOR PLG

Guaifenesin Syrup 100 mg/ 5 ml CTD Ready IOR PLG

Guaifenesin + Dextromethorphan HBr + Diphenhydramine HCl + Ephedrine HCl

Syrup 50 mg, 6.25 mg, 5 mg, 7.5 mg/ 5 ml CTD Ready IOR PLG

Hexetidine Solution - Oral 0.1 % w/v CTD Ready IOR PLG

Hydrocortisone Acetate, Balsam peru, Zinc Oxide, Benzyl benzoate, Bismuth Oxide, Bismuth Subgallate

Suppository 10 mg, 49 mg, 296 mg, 33 mg, 24 mg, 59 mg CTD Ready IOR PLG

Hydrocortisone Acetate, Balsam peru, Zinc Oxide, Benzyl benzoate, Bismuth Oxide, Bismuth Subgallate

Topical 0.25 g, 1.875 g, 10.75 g, 1.25 g, 0.875 g, 2.25 g CTD Ready IOR PLG

Hydrocortisone Hemisuccinate Injection 100 mg CTD Ready IOR PLG

Hydroxychloroquine Tablet 200 mg CTD Ready IOR PLG

Hyoscine Butylbromide Tablet 10 mg CTD Ready IOR PLG

Hyoscine Butylbromide Syrup 5 mg/ 5 ml CTD Ready IOR PLG

Hyoscine Butylbromide Injection 20 mg/ 1 ml CTD Ready IOR PLG

Ibuprofen Syrup 100 mg/ 5 ml CTD Ready IOR PLG

Ibuprofen Tablet 400 mg CTD Ready IOR PLG


Ibuprofen Suppository 200 mg CTD Ready IOR PLG


Ibuprofen + Paracetamol Syrup 100 mg, 125 mg/ 5 ml CTD Ready IOR PLG

Imatinib Mesilate Tablet 100 mg (Tablets) CTD Ready IOR PLG

Imatinib Mesilate Tablet 400 mg (Tablets) CTD Ready IOR PLG

Indometacin Capsule 25 mg CTD Ready IOR PLG

Irinotecan Injection 40 mg/ 2 ml CTD Ready IOR PLG

HIKMA

32




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Irinotecan Injection 100 mg/ 5 ml CTD Ready IOR PLG

Isoconazole Nitrate Topical 10 mg/ g CTD Ready IOR PLG

Isoconazole Nitrate + Diflucortolone Valerate

Topical 10 mg, 1 mg/ g CTD Ready IOR PLG

Itopride HCl Tablet 50 mg CTD Ready IOR PLG

Itraconazole Capsule 100 mg CTD Ready IOR PLG

Ketamine Injection 50 mg/ ml (vials) CTD Ready IOR PLG

Ketotifen Tablet 1 mg CTD Ready IOR PLG

Ketotifen Syrup 1 mg/ 5 ml CTD Ready IOR PLG

Lamotrigine Tablet 25 mg CTD Ready IOR PLG



Leflunomide Tablet 10 mg CTD Ready IOR PLG



Levetiracetam Syrup 100 mg/ 1 ml CTD Ready IOR PLG

Levetiracetam Tablet 250 mg CTD Ready IOR PLG



Levofloxacin Tablet 500 mg CTD Ready IOR PLG

Levofloxacin Tablet 750 mg CTD Ready IOR PLG

Levofloxacin Injection 5 mg/ ml (vials) CTD Ready IOR PLG

Levofloxacin Injection 5 mg/ ml (bags) CTD Ready IOR PLG

Lincomycin Injection 300 mg/ ml (vials) CTD Ready IOR PLG

Lisinopril Tablet 5 mg CTD Ready IOR PLG



HIKMA

33




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS


Lomefloxacin hydrochloride Tablet 400 mg CTD Ready IOR PLG

Loratadine Tablet 10 mg CTD Ready IOR PLG

Loratadine Syrup 5 mg/ 5 ml CTD Ready IOR PLG

Losartan Potassium Tablet 25 mg CTD Ready IOR PLG



Losartan Potassium + HCTZ Tablet 50 mg, 12.5 mg CTD Ready IOR PLG

Losartan Potassium + HCTZ Tablet 100 mg, 25 mg CTD Ready IOR PLG

Mebeverine HCl Tablet 135 mg CTD Ready IOR PLG

Mefenamic Acid Capsule 250 mg CTD Ready IOR PLG

Mefenamic Acid Tablet 250 mg CTD Ready IOR PLG

Mefenamic Acid Tablet 500 mg CTD Ready IOR PLG

Mefenamic Acid Syrup 50 mg/ 5 ml CTD Ready IOR PLG

Meloxicam Capsule 7.5 mg CTD Ready IOR PLG

Meloxicam Capsule 15 mg CTD Ready IOR PLG

Metformin HCl Tablet 500 mg CTD Ready IOR PLG

Metformin HCl Tablet 850 mg CTD Ready IOR PLG

Methylprednisolone Injection 40 mg CTD Ready IOR PLG

Metoclopramide HCl Injection 10 mg/ 2 ml CTD Ready IOR PLG

Metoprolol Tartrate Injection 5 mg/ 5 ml ANDA Ready IOR PLG

Metronidazole Syrup 125 mg/ 5 ml CTD Ready IOR PLG

Metronidazole Syrup 200 mg/ 5 ml CTD Ready IOR PLG

Metronidazole Tablet 250 mg CTD Ready IOR PLG

Metronidazole Tablet 500 mg CTD Ready IOR PLG

Metronidazole + Diloxanide furoate Tablet 200 mg, 250 mg CTD Ready IOR PLG

Metronidazole + Spiramycin Tablet 125 mg, 750.000 IU CTD Ready IOR PLG

HIKMA

34




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Midazolam Injection 1 mg/ ml (Ampoules) CTD Ready IOR PLG

Midazolam Injection 5 mg/ ml (Ampoules) CTD Ready IOR PLG

Milrinone Injection 1 mg/ ml CTD Ready IOR PLG

Milrinone Injection 1 mg/ ml ANDA Ready IOR PLG

Milrinone Injection 2 mg/ ml ANDA Ready IOR PLG

Montelukast Tablet 5 mg CTD Ready IOR PLG

Montelukast Tablet 10 mg CTD Ready IOR PLG

Multivitamins Syrup Combination of 9 vitamins CTD Ready IOR PLG

Multivitamins Tablet Combination of 12 vitamins CTD Ready IOR PLG

Naftidrofuryl Oxalate Capsule 200 mg CTD Ready IOR PLG

Naloxone HCl Injection 0.02 mg (Ampoules) CTD Ready IOR PLG

Naloxone HCl Injection 0.4 mg (Ampoules) CTD Ready IOR PLG

Naproxen Tablet 250 mg CTD Ready IOR PLG

Naproxen Suppository 500 mg CTD Ready IOR PLG

Naproxen Tablet 500 mg CTD Ready IOR PLG

Naproxen Syrup 125 mg/ 5 ml CTD Ready IOR PLG

Nebivolol Tablet 5 mg CTD Ready IOR PLG

Nicorandil Tablet 10 mg CTD Ready IOR PLG

Nicorandil Tablet 20 mg CTD Ready IOR PLG

Nifuroxazide Capsule 200 mg CTD Ready IOR PLG

Nifuroxazide Syrup 220 mg/ 5 ml CTD Ready IOR PLG

Nimesulide Tablet 100 mg CTD Ready IOR PLG

Nimesulide Suppository 200 mg CTD Ready IOR PLG

Norethisterone Tablet 5 mg CTD Ready IOR PLG

Norfloxacin + Tinidazole Tablet 400 mg, 600 mg CTD Ready IOR PLG

Olanzapine Tablet 5 mg CTD Ready IOR PLG

Ondansetron Injection 32 mg/ 50 ml (Bags) CTD Ready IOR PLG

HIKMA

35




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Ondansetron Tablet 4 mg (Tablets) CTD Ready IOR PLG

Ondansetron Tablet 8 mg (Tablets) CTD Ready IOR PLG

Ondansetron Injection 4 mg/ 2 ml CTD Ready IOR PLG

Ondansetron Injection 4 mg/ 2 ml ANDA Ready IOR PLG

Ondansetron Injection 8 mg/ 4 ml CTD Ready IOR PLG

Orlistat Capsule 120 mg CTD Ready IOR PLG

Ornidazole Tablet 500 mg CTD Ready IOR PLG

Oxomemazine + Sodium Benzoate + Guaifenesin + Paracetamol

Syrup 1.65 mg, 33.3 mg, 33.3 mg, 33.3 mg/ 5 ml CTD Ready IOR PLG

Pamidronate / Pamidronic Acid Injection 15 mg/ 5 ml CTD Ready IOR PLG




Pancuronium Bromide Injection 2 mg/ ml (Ampoules) CTD Ready IOR PLG

Paracetamol Syrup 120 mg/ 5 ml CTD Ready IOR PLG



Paracetamol Tablet 500 mg CTD Ready IOR PLG

Paracetamol Tablet 500 mg CTD Ready IOR PLG

Paracetamol Suppository 250 mg CTD Ready IOR PLG








HIKMA

36




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Paracetamol Drops 100 mg/ ml CTD Ready IOR PLG

Paracetamol Injection 1 g/ 100 ml (Vials) CTD Ready IOR PLG

Paracetamol + Caffeine Tablet 500 mg, 65 mg CTD Ready IOR PLG

Paracetamol + Codeine Tablet 500 mg, 10 mg CTD Ready IOR PLG

Paracetamol + DL - Methionine Tablet 500 mg, 100 ml CTD Ready IOR PLG

Paracetamol + Phenobarbital Suppository 125 mg, 10 mg CTD Ready IOR PLG

Paracetamol + Phenobarbital Suppository 250 mg, 20 mg CTD Ready IOR PLG

Paracetamol + Pseudoephedrine HCl Tablet 500 mg, 30 mg CTD Ready IOR PLG

Paracetamol + Pseudoephedrine HCl + Chlorpheniramine maleate

Tablet 500 mg, 30 mg, 2 mg CTD Ready IOR PLG


Tablet 500 mg, 30 mg, 2 mg CTD Ready IOR PLG


Syrup 160 mg, 15 mg, 1 mg/ 5 ml CTD Ready IOR PLG

Phenobarbital Tablet 15 mg CTD Ready IOR PLG



Phenytoin Injection 50 mg/ ml CTD Ready IOR PLG

Phenytoin Injection 50 mg/ ml ANDA Ready IOR PLG

Piroxicam Injection 20 mg/ ml CTD Ready IOR PLG

Pizotifen Syrup 0.5 mg/ 5 ml CTD Ready IOR PLG

Prednisolone Tablet 5 mg CTD Ready IOR PLG

Prednisolone Tablet 25 mg CTD Ready IOR PLG

Prednisolone Syrup 5 mg CTD Ready IOR PLG

Prednisolone Syrup 15 mg CTD Ready IOR PLG

Pregabalin Capsule 75 mg CTD Ready IOR PLG

Pregabalin Capsule 150 mg CTD Ready IOR PLG

Progesterone Injection 50 mg/ ml ANDA Ready IOR PLG

HIKMA

37




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Promethazine Injection 25 mg/ ml ANDA Ready IOR PLG

Promethazine Injection 50 mg/ ml CTD Ready IOR PLG

Promethazine Injection 50 mg/ ml ANDA Ready IOR PLG

Propranolol Tablet 10 mg CTD Ready IOR PLG



Propranolol Injection 1 mg/ ml ANDA Ready IOR PLG

Ranitidine Tablet 75 mg CTD Ready IOR PLG



Ranitidine Injection 50 mg/ 2 ml CTD Ready IOR PLG

Ribavirin Capsule 200 mg CTD Ready IOR PLG

Ribavirin Capsule 400 mg CTD Ready IOR PLG

Risedronate Tablet 35 mg CTD Ready IOR PLG

Risedronate Sodium+Calcium carbonate Tablet 35 mg, 1250 mg CTD Ready IOR PLG

Risperidone Tablet 1 mg CTD Ready IOR PLG



Rivastigmine tartrate Capsule 1.5 mg CTD Ready IOR PLG

Rivastigmine tartrate Capsule 3 mg CTD Ready IOR PLG

Rivastigmine tartrate Capsule 4.5 mg CTD Ready IOR PLG

Rivastigmine tartrate Capsule 6 mg CTD Ready IOR PLG

Rosuvastatin Ca Tablet 10 mg CTD Ready IOR PLG

Rosuvastatin Ca Tablet 20 mg CTD Ready IOR PLG

Salbutamol Tablet 2 mg CTD Ready IOR PLG

Salbutamol Syrup 2 mg/ 5 ml CTD Ready IOR PLG

Sennosides Tablet 7.5 mg CTD Ready IOR PLG

HIKMA

38




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Sertraline Tablet 50 mg CTD Ready IOR PLG

Sertraline Tablet 100 mg CTD Ready IOR PLG

Sildenafil Tablet 50 mg CTD Ready IOR PLG

Simvastatin Tablet 10 mg CTD Ready IOR PLG



Simvastatin + Ezetimibe Tablet 20 mg, 10 mg CTD Ready IOR PLG

Simvastatin + Ezetimibe Tablet 40 mg, 10 mg CTD Ready IOR PLG

Sitagliptin Tablet 50 mg CTD Ready IOR PLG

Sitagliptin Tablet 100 mg CTD Ready IOR PLG

Sitagliptin + Metformin Tablet 50 mg, 1 g CTD Ready IOR PLG

Sodium Bicarbonate Capsule 500 mg CTD Ready IOR PLG

Sodium Fusidate Topical 20 mg/ g CTD Ready IOR PLG

Sodium Iron Edetate Syrup 15 mg Iron/ 5 ml CTD Ready IOR PLG

Sodium Valproate Injection 100 mg/ ml ANDA Ready IOR PLG

Somatostatin Injection 1 mg + 2 ml, 3 mg + 2 ml CTD Ready IOR PLG

Sufentanil (citrate) Injection 10 mcg/ 2 ml CTD Ready IOR PLG




Sulfamethoxazole + Trimethoprim Syrup 200 mg, 40 mg/ 5 ml CTD Ready IOR PLG

Sulfamethoxazole + Trimethoprim Tablet 400 mg, 80 mg CTD Ready IOR PLG

Sulfamethoxazole + Trimethoprim Tablet 800 mg, 160 mg CTD Ready IOR PLG

Sumatriptan Succinate Tablet 50 mg CTD Ready IOR PLG

Sumatriptan Succinate Capsule 100 mg CTD Ready IOR PLG

Teicoplanin Injection 200 mg (vials) CTD Ready IOR PLG

Teicoplanin Injection 400 mg (vials) CTD Ready IOR PLG

HIKMA

39




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Terbinafine HCl Topical 10 mg/ g CTD Ready IOR PLG

Terbutaline Sulphate Injection 1 mg/ ml ANDA Ready IOR PLG

Thiamine HCl, Pyridoxine HCl, Riboflavin 5-phosphate Sodium, Nictotinamide, Ascorbic Acid, Sodium D-panthothenate

Syrup1.67 mg, 1.00 mg, 1.41 mg, 6.67 mg, 33.33 mg, 1.67 mg/ 5 ml

CTD Ready IOR PLG

Tioconazole Topical 10 mg/ g CTD Ready IOR PLG

Tizanidine HCl Tablet 4 mg CTD Ready IOR PLG

Tramadol HCl Capsule 50 mg CTD Ready IOR PLG

Tramadol HCl Tablet 200 mg CTD Ready IOR PLG

Tramadol HCl Injection 100 mg/ 2 ml CTD Ready IOR PLG

Triamcinolone Acetonide + Neomycin + Gramicidin + Nystatin

Topical 1 mg, 2.5 mg, 0.25 mg, 100 000 IU/ g CTD Ready IOR PLG

Tribenoside + Lidocaine Topical 5 mg, 2 g CTD Ready IOR PLG

Triprolidine + Pseudoephedrine HCl Syrup 1.25 mg, 30 mg/ 5 ml CTD Ready IOR PLG

Triprolidine + Pseudoephedrine HCl Tablet 2.5 mg, 60 mg CTD Ready IOR PLG

Triprolidine + Pseudoephedrine HCl + Dextromethorphan HBr

Syrup 1.25 mg, 30 mg, 10 mg/ 5 ml CTD Ready IOR PLG

Triprolidine + Pseudoephedrine HCl + Guaifenesin


Triprolidine + Pseudoephedrine HCl + Paracetamol


Triprolidine + Pseudoephedrine HCl + Paracetamol

Tablet 2.5 mg, 50 mg, 300 mg CTD Ready IOR PLG

Trospium Tablet 20 mg CTD Ready IOR PLG

Valacyclovir Tablet 1 g CTD Ready IOR PLG

Vancomycin HCl Injection 500 mg CTD Ready IOR PLG

Vancomycin HCl Injection 1000 mg CTD Ready IOR PLG

Vecuronium Bromide Injection 4 mg (Vials) CTD Ready IOR PLG

Vecuronium Bromide Injection 10 mg (Vials) CTD Ready IOR PLG

HIKMA

40



COMPANY NAMELogenex

COUNTRYGermany

CITYHamburg

LOGENEX Pharm GmbH offers sophisticated services and products for pharmaceutical companies. The company’s main business is the development of registration dossiers for generic drugs and worldwide licensing - with a special focus on oncology. We work closely with external experts in the field of drug development, API sourcing and Regulatory Affairs. This guarantees high quality results at competitive conditions for our Customers.

Core Sales Territory: Global Regulated MarketsCore Operation: Distribution, Finished Dose Manufacture, API ManufactureContact Person: Mr. Franz Rieger; Area Manager


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Topotecan Injection - Powder 1 mg, 4 mg CTD Ready Germany DCP underway

Zoledronic Acid Injection - Solution 4 mg / 5 ml CTD In-Dev N / ADCP slot booked (Aug 2011)

Alprazolam Tablet 0.5 mg IOR Ready Brazil Approved

Ambroxol Solution - Oral 3 mg/ml, 6 mg/ml IOR Ready Brazil Approved

41



COUNTRYUnited Kingdom

CITYKnutsford

COMPANY NAMELupin

Established in 1968 in India, Lupin’s vision is to be an innovation led transnational pharmaceutical company. Lupin is amongst the top 5 Indian pharmaceutical companies with world class EU GMP and USFDA approved manufacturing facilities. Lupin aims to be the partner of choice for economic and high quality pharmaceutical development and manufacturing. Offers: out-licensing and supply arrangements for its generic products/dossiers (CTD format), supply of APIs, generic dossier co-development and contract research & development.A drive for excellence through technology and research has earned Lupin a position in the top league of pharmaceutical companies from India. Lupin has become a global leader in the anti-TB segment and one of the world’s largest integrated manufacturers of cephalosporins, having sterile injectable, tablet, capsule and suspensions for reconstitution forms available. Lupin also leads in the manufacture of cardiovascular drugs, has significant fermentation capabilities producing drugs from the Statin class; and a range of developments spanning Sartans and Prazoles. Lupin’s Innovation Cell is focused on the development of drug delivery systems including taste-masking, chewable, tablet to liquid, invasive to noninvasive, oral controlled release and others.Core Sales Territory: Global Regulated MarketsCore Operation: Distribution, Sales and Marketing, Finished Dose Manufacture, API ManufactureContact Person: Mr. Andrew Macaulay; Vice President (BD)


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Aspirin + Dipyridamole Capsule - XR 25 + 200mg eCTD In-Dev N / A IOR

Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg eCTD In-Dev N / A IOR

Bimatoprost Drops - Eye 0.03% eCTD In-Dev N / A IOR

Bimatoprost + Timolol Drops - Eye 0.03% + 0.5% eCTD In-Dev N / A IOR

Brimonidine Drops - Eye 0.2% eCTD In-Dev N / A IOR

Brimonidine + Timolol Drops - Eye 0.2% + 0.5% eCTD In-Dev N / A IOR

Brinzolamide Drops - Eye 1% eCTD In-Dev N / A IOR

Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg eCTD In-Dev N / A IOR

Candesartan + HCTZ Tablet8 mg + 12.5 mg, 16 mg + 12.5 mg, 32 mg + 12.5 mg, 32 mg + 25 mg

eCTD In-Dev N / A IOR

Cefixime Suspension 100 mg/5ml CTD Ready IOR DCP underway

Cefixime Tablet 200, 400mg CTD Ready IOR DCP underway

Cefotaxime Injection - Solution 500 mg, 1000 mg, 2000 mg NTA Ready UK IOR

Cefpodoxime Proxetil Suspension 40 mg / 5ml CTD Ready France DCP underway

Cefpodoxime Proxetil Tablet 100 mg, 200 mg CTD Ready France DCP underway

Ceftriaxone Injection - Solution 250 mg, 500 mg, 1000 mg, 2000 mg NTA Ready UK IOR

Cephalexin Capsule 250 mg, 500 mg eCTD Ready IOR DCP underway

Chlormadinone + EE Tablet 2 mg + 0.03 mg eCTD In-Dev N / A IOR

42




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Clarithromycin Tablet - XR 500 mg eCTD In-Dev N / A IOR

Desloratadine Tablet 5 mg CTD Ready IOR IOR

Desogestrel Tablet 0.075 mg eCTD In-Dev N / A IOR

Desogestrel + EE Tablet 0.15 mg + 0.02 mg eCTD In-Dev N / A IOR

Desogestrel + EE Tablet 0.15 mg + 0.03 mg eCTD In-Dev N / A IOR

Diacerein Capsule 50 mg CTD Ready IOR IOR

Dienogest + EE Tablet 2 mg + 0.03mg eCTD In-Dev N / A IOR

Dienogest + Estradiol Valerate Tablet 2 mg + 1 mg, 2 mg + 2 mg eCTD In-Dev N / A IOR

Dienogest + Estradiol Valerate Tablet 0/3 + 2/2 + 3/2 + 0/1mg eCTD In-Dev N / A IOR

Dorzolamide Drops - Eye 2% eCTD In-Dev N / A IOR

Dorzolamide + Timolol Drops - Eye 2%/0.5% eCTD In-Dev N / A IOR

Drospirenone + EE Tablet 3 mg + 0.03 mg eCTD In-Dev N / A IOR

Drospirenone + EE Tablet 3 mg + 0.02 mg eCTD In-Dev N / A IOR

Duloxetine Capsule 20 mg, 30 mg, 40 mg, 60 mg eCTD In-Dev N / A IOR

Escitalopram Tablet 5 mg, 10 mg, 15 mg, 20 mg CTD Ready IOR IOR

Esomeprazole Tablet 20 mg, 40 mg eCTD In-Dev N / A IOR

Flupirtine Capsule 100 mg eCTD In-Dev N / A IOR

Flupirtine Tablet - SR 400 mg eCTD In-Dev N / A IOR

Gestodene + EE Tablet 0.075/0.02mg eCTD In-Dev N / A IOR



Gliclazide Tablet - SR 30 mg eCTD In-Dev N / A IOR

Irbesartan Tablet 75 mg, 150 mg, 300 mg eCTD In-Dev N / A IOR

Irbesartan + HCTZ Tablet150 mg + 12.5 mg, 300 mg + 12.5 mg, 300 mg + 25 mg


Ketoprofen Tablet - XR 150 mg eCTD In-Dev N / A IOR

Lamivudine + Zidovudine Tablet 150 mg + 300 mg eCTD In-Dev N / A IOR

LUPIN

43




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Lansoprazole Capsule 15 mg, 30 mg eCTD In-Dev N / A IOR

Lansoprazole Tablet - Dispersible (ODT) 15 mg, 30 mg eCTD In-Dev N / A IOR

Latanoprost Drops - Eye 50 µg/ml (2.5 ml) eCTD In-Dev N / A IOR

Latanoprost + Timolol Drops - Eye 0.005% + 0.5% eCTD In-Dev N / A IOR

Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready IOR DCP underway

Levonorgestrel Tablet 1.5 mg eCTD In-Dev N / A IOR

Levonorgestrel + EE Tablet 0.15 mg + 0.03 mg eCTD In-Dev N / A IOR



Levonorgestrel + EE Tablet0.05 mg + 0.03 mg, 0.075 mg + 0.04 mg, 0.125 mg + 0.03 mg


Lisinopril Tablet 2.5 mg, 5 mg, 10 mg, 20 mg CTD Ready France MRP underway: UK

Lisinopril + HCTZ Tablet 10 mg + 12.5 mg, 20 mg + 12.5 mg CTD Ready UK MRP underway: UK

Losartan Tablet 12.5, 25, 50, 100mg CTD Ready France MRP underway: UK

Losartan + HCTZ Tablet50 mg + 12.5 mg, 100 mg + 12.5 mg, 100 mg + 25 mg

CTD Ready France MRP underway: UK

Memantine Tablet 5 mg, 10 mg, 15 mg, 20 mg eCTD Ready IOR IOR

Memantine Tablet 5 mg, 10 mg, 15 mg, 20 mg ANDA Ready IOR PLG

Norgestimate + EE Tablet 0.25 mg + 0.35 mg eCTD In-Dev N / A IOR

Omeprazole Capsule 10, 20, 40mg eCTD In-Dev N / A IOR

Pantoprazol Tablet 20 mg, 40 mg CTD Ready IOR DCP underway

Perindopril Tablet 2 mg, 4 mg, 8 mg CTD Ready France MRP underway: UK

Perindopril + Indapamide Tablet 2 mg + 0.625 mg, 4 mg + 1.25 mg CTD Ready IOR PLG

Pregabalin Capsule25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg


Quetiapine Tablet 25mg, 100mg, 150mg, 200mg, 300mg eCTD In-Dev N / A IOR

Quetiapine Tablet - SR 50 mg, 200 mg, 300 mg, 400 mg eCTD In-Dev N / A IOR

LUPIN

44




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Quinapril Tablet 5 mg, 10 mg, 20 mg, 40 mg CTD Ready UK MRP underway: UK

Rabeprazole Tablet 10 mg, 20 mg eCTD In-Dev N / A IOR

Ramipril Capsule 1.25, 2.5, 5, 10mg CTD Ready UK MRP underway: UK

Ramipril Tablet 1.25, 2.5, 5, 10mg eCTD In-Dev N / A IOR

Ramipril + HCTZ Tablet2.5 mg + 12.5 mg, 5 mg + 12.5 mg, 5 mg + 25 mg


Risperidone Tablet 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg CTD Ready IOR DCP underway

Sertraline Tablet 50 mg, 100 mg CTD Ready UK MRP underway: UK

Sevelamer Tablet 400 mg, 800 mg eCTD In-Dev N / A IOR

Simvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg CTD Ready UK MRP underway: UK

Tianeptine Tablet 12.5 mg eCTD In-Dev N / A IOR

Tobramycin + Dexamethasone Drops - Eye 0.3%/0.1% eCTD In-Dev N / A IOR

Tolterodine Capsule - XR 2 mg, 4 mg eCTD In-Dev N / A IOR

Topiramate Tablet 25 mg, 50 mg, 100 mg, 200 mg CTD Ready France DCP underway

Tramadol + Paracetamol Tablet 37.5 mg + 325 mg eCTD In-Dev N / A IOR

Trandolapril Capsule 0.5 mg, 1 mg, 2 mg, 4 mg CTD Ready France MRP underway: UK

Travoprost Drops - Eye 0.004% eCTD In-Dev N / A IOR

Travoprost + Timolol Drops - Eye (0.04 mg + 5 mg)/ml eCTD In-Dev N / A IOR

Trimetazidine Tablet - SR 35 mg eCTD Ready IOR DCP underway

Trospium Tablet 5, 10, 15, 20, 30mg eCTD In-Dev N / A IOR

Urapidil Capsule - XR 30 mg, 60 mg, 90 mg eCTD In-Dev N / A IOR

Valsartan Tablet 40 mg, 80 mg, 160 mg, 320 mg CTD Ready France DCP underway

Valsartan + HCTZ Tablet80 mg + 12.5 mg, 160 mg + 12.5 mg, 160 mg + 25 mg, 320 mg +25 mg


Venlafaxine Capsule - XR 37.5, 75, 150mg CTD Ready IOR DCP underway

Ziprasidone Capsule 20 mg, 40 mg, 60 mg, 80 mg eCTD In-Dev N / A IOR

LUPIN

45



COUNTRYSwitzerland

CITYOberwill

COMPANY NAMENaari

NAARI AG is focused in the female healthcare segment, specializing in female hormonal products in which we are fully integrated. We are producing key intermediates, API’s and finished hormonal formulationsCore Sales Territory: Global Regulated MarketsCore Operation: API Manufacture, Finished Dose Manufacture, Sales and MarketingContact Person: Mr Supreet Sharma; Business Development Manager


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Chlormadinone + EE Tablet 2 MG + 0.03 MG CTD In-Dev N / A DCP slot booked

Dienogest Tablet 2 MG CTD IOR N / A IOR

Dienogest + EE Tablet 2 MG + 0.03 MG CTD In-Dev N / A IOR

Disulfiram Tablet 200 MG & 500 MG CTD In-Dev N / ADCP slot booked (Apr 2012)

Levonorgestrel Tablet 0.75 MG CTD Ready N / A IOR

Levonorgestrel Tablet 1.5 MG CTD In-Dev N / A IOR

Levonorgestrel + EE Tablet 0.15 MG + 0.03 MG CTD In-Dev N / A IOR

Mifepristone Tablet 200 MG CTD In-Dev N / A IOR

Misoprostol Tablet 200 MCG CTD In-Dev N / A IOR

Norethisterone Tablet 5 MG CTD In-Dev N / A IOR

46



COUNTRYBelgium

CITYDiegem

COMPANY NAMENeogen

Neogen is a company dedicated to the development of injectable products. All products are manufactured in EU-GMP facilities, mainly in Europe. Neogen is looking for partners with a presence in the hospital market.

Core Sales Territory: Global Regulated MarketsCore Operation: Sales and Marketing, Finished Dose ManufactureContact Person: Mr Thomas Jacobsen; Licensing Director


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Diclofenac Drops - Eye 0.1 % (unitdose) NTA Ready Denmark PLG

Esomeprazole Injection - Powder 40 mg eCTD In-Dev N / A DCP slot booked

Fluconazole Injection - Solution 2 mg/ml (50 ml, 100 ml, 200 ml) eCTD Ready France PLG

Fucidic Acid Cream 2% eCTD Ready N / A DCP underway

Ipratropium Nebuler 0.125 g/ml (2 ml) eCTD Ready Denmark PLG

Ipratropium Nebuler 0.25 g/ml (0.5 ml, 1 ml, 2 ml) eCTD Ready Denmark PLG

Ipratropium + Salbutamol Inhaler 2,5 + 0,5 mg eCTD Ready Denmark PL <12months

Ketotifen Drops - Eye 0.25 mg/ml (unitdose) eCTD Ready Denmark IOR

Ofloxacin Drops - Eye 0.3% (unit & multidose) eCTD Ready Denmark PL <12months

Pantoprazol Injection - Powder 40 mg eCTD Ready Denmark PLG

Paracetamol Injection 10 mg/ml eCTD Ready IOR PLG

Paracetamol Tablet 500 mg, 650 mg, 1000 mg eCTD In-Dev N / A DCP slot booked

Prednisolone Tablet 2,5; 5, 10, 20, 25 mg eCTD Ready IOR PLG

Ropivacaine Powder 2 mg/ml, 5 mg/ml, 7.5 mg/ml, 10 mg/ml eCTD Ready N / A NRP

Sodium Chromoglycate Drops - Eye 2 % (unitdose) eCTD Ready Denmark PLG

Teicoplanin Powder 200 mg, 400 mg eCTD Ready N / A PL <12months

Tropicamide Drops - Eye 0.5% (5 ml) (unit & multidose) eCTD Ready Denmark PLG

Xylometazoline Spray - Nasal 0,5 & 1 mg/ml eCTD Ready Europe PLG

Xylometazoline + eteric oil Spray - Nasal 0,05 & 0,1 % eCTD Ready N / A PL <12months

47



COUNTRYFinland

CITYEspoo

COMPANY NAMEOrion

Orion Corporation develops, manufactures and markets pharmaceuticals, active pharmaceutical ingredients and diagnostic tests for global markets. Orion has been building well-being for over 90 years.Orion’s clientele consists of healthcare service providers and professionals, such as doctors, pharmacies, hospitals, healthcare centers, clinics and laboratories. The core therapy areas in Orion’s product and research strategy are: central nervous system, oncology and critical care , and respira-tory medicines administered with the Easyhaler device. Orion has also a large portfolio of generic, off-patent prescription medicines, hospital treatments and self-care products. These products are sold mainly in Finland, other Nordic countries, the new EU countries and Germany. The subsidiary Fermion produces active pharmaceutical ingredients for both Orion and other pharmaceutical companies.Core Sales Territory: All of EuropeCore Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, DistributionContact Person: Mr Marko Salo; VP (Marketing & Sales)


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Propafenone Tablet - IR 150mg, 300mg eCTD Ready N/A DCP Slot booked

48



COUNTRYSwitzerland

CITYTicino

COMPANY NAMERivopharm

Rivopharm is a Swiss company located near Lugano in the Ticino area. The core business of the company is the development and manufacture of pharmaceutical products in the generic field.With a strong regulatory department, a well motivated and efficient Research & Development team and a modern factory, we are ready to provide a customer oriented approach towards Research and Development, registration and production, while maintain-ing the Swiss reputation of efficiency, high quality and reliability.

Core Sales Territory: All of EuropeCore Operation: Finished Dose Manufacture Contact Person: Mr Nico Pianta; Commercial Director


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Alfuzosin Tablet - SR 10 mg CTD Ready IOR PLG

Amiodarone Tablet 100 mg, 200 mg CTD Ready IOR PLG

Amisulpride Tablet 50 mg, 100 mg, 200 mg, 400 mg CTD Ready IOR PLG

Bisoprolol Tablet 5 mg, 10 mg CTD Ready IOR PLG

Citalopram Tablet 10 mg, 20 mg, 30 mg, 40 mg CTD Ready IOR PLG

Clindamycin Tablet 150 mg, 300 mg CTD Ready N / A DCP underway

Domperidone Tablet 10 mg CTD Ready IOR PLG

Gabapentin Capsule 100 mg, 300 mg, 400 mg CTD Ready IOR PLG

Gabapentin Tablet 600 mg, 800 mg CTD Ready IOR PLG

Lacidipine Tablet 2 mg, 4 mg, 6 mg CTD In-Dev N / A NRP

Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready N / A DCP slot booked

Milnacipram Capsule 25 mg, 50 mg CTD In-Dev N / A NRP

Moxifloxacin Tablet 400 mg CTD In-Dev N / A IOR

Nicorandil Tablet 10 mg, 20 mg CTD Ready IOR PLG

Repaglinide Tablet 0.5 mg, 1 mg, 2 mg CTD Ready IOR PLG

Ropinirole Tablet 0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg CTD Ready IOR PLG

Tranexamic Acid Tablet 500 mg CTD Ready IOR PLG

Zolpidem Tablet 5 mg, 10 mg CTD Ready IOR PLG

49



COUNTRYPortugal

CITYAbrunheira

COMPANY NAMETechnimede

Tecnimede Group is a privately owned group of pharmaceutical companies dedicated to the development, registration, manufac-turing, promotion and sale of pharmaceutical products for human use. We have a strong position in the generic medicines market and a clear orientation to quality and technological innovation. Considering R&D activities as a key factor in our development strategy, Tecnimede Group has been distinguished by Portuguese governmental institutions for its investment of important financial resources in R&D Activities.Working with CROs in Spain and Canada, we have a large experience in conducting BD / BE studies and a portfolio of more then 75 generic medicines that are being registered (locally, by DCP or MRP Procedure) all over Europe and in several countries outside the European Union. Core Sales Territory: All of Europe, Regulated MarketCore Operation: Finished Dose Manufacturer, Sales and MarketingContact Person: Ms Rita Ferreira; Business Development Manager


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Acarbose Tablet 50mg and 100mg eCTD Ready Portugal IOR

Alendronate / Alendronic Acid Tablet - Film coated 70mg eCTD Ready Portugal IOR

Amlodipine Tablet 5mg and 10mg eCTD Ready Portugal IOR

Aripiprazole Tablet - Dispersible (ODT) 2mg/ 5mg/ 10mg/ 15mg/ 20mg and 30mg eCTD In-Dev N / A IOR

Aripiprazole Tablet 2mg/ 5mg/ 10mg/ 15mg/ 20mg and 30mg eCTD In-Dev N / A IOR

Azithromycin Powder - Infusion 500mg eCTD Ready Portugal IOR

Bicalutamide Tablet - Film coated 50mg and 150mg eCTD Ready Portugal IOR

Calcipotriol Cream 0,05mg/g eCTD In-Dev N / A IOR

Calcipotriol Ointment 0,05mg/g eCTD In-Dev N / A IOR

Calcipotriol Solution - Cutaneous 0,05mg/g eCTD In-Dev N / A IOR

Calcipotriol + Betametasone Dipropionate

Ointment 0,05mg/g + 0,5mg/g eCTD In-Dev N / A IOR

Candesartan Tablet 2mg/ 4mg/ 8mg/ 16mg and 32mg eCTD In-Dev N / A IOR

Candesartan + HCTZ Tablet8mg + 12,5mg/ 16mg + 12,5mg and 32 mg + 25mg


Captopril Tablet 25mg and 50mg eCTD Ready Portugal IOR

Carvedilol Tablet 6,25mg and 25mg eCTD Ready Portugal IOR

Celecoxib Capsule 100mg and 200mg eCTD In-Dev N / A IOR

Cinnarizine + Dimenhydrinate Tablet 60mg and 120mg eCTD In-Dev N / A IOR

50




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Ciprofloxacin Tablet - Film coated 250mg and 500mg eCTD Ready Portugal IOR

Ciprofloxacin Injection - Bottle 2mg/ml - 100ml and 200ml eCTD Ready Portugal IOR

Clopidogrel + Aspirin (ASA) Tablet 75mg + 75mg and 75mg + 100mg eCTD In-Dev N / A IOR

Clopidogrel Hydrogenbisulphat Tablet - Film coated 75mg eCTD Ready Portugal IOR

Donepezil Tablet - Film coated 5mg and 10mg eCTD Ready Portugal IOR

Enalapril + HCTZ Tablet 20mg + 12,5mg eCTD Ready Portugal IOR

Eplerenone Tablet - Film coated 25mg and 50mg eCTD In-Dev N / A IOR

Escitalopram Solution - Oral 10mg/ml and 20mg/ml eCTD Ready Portugal IOR

Escitalopram Tablet - Film coated 5mg/ 10mg/ 15mg and 20mg eCTD Ready Portugal IOR

Esomeprazole Powder - Infusion 40mg eCTD In-Dev N / A IOR

Ezetimibe + Sinvastatina Tablet - Film coated10mg + 10mg/ 10mg + 20mg/ 10mg + 40mg and 10mg + 80mg


Finasteride Tablet 5mg eCTD Ready Portugal IOR

Fluconazole Capsule 50mg/ 150mg and 200mg eCTD Ready Portugal IOR

Fosfomycine Injection - Solution 1g and 4g eCTD In-Dev N / A IOR

Fosfomycine Granules 2g and 3g eCTD In-Dev N / A IOR

Gabapentin Tablet 600mg and 800mg eCTD Ready Portugal IOR

Gabapentin Capsule 100mg/ 300mg and 400mg eCTD Ready Portugal IOR

Ibandronate / Ibandronic Acid Tablet - Film coated 50mg and 150mg eCTD In-Dev N / A IOR

Ibandronate / Ibandronic Acid Injection - Solution 3mg/ml eCTD In-Dev N / A IOR

Ibandronate / Ibandronic Acid Injection - Solution 1mg/ml (4ml and 6ml) eCTD In-Dev N / A IOR

Irbesartan Tablet - Film coated 75mg/ 150mg and 300mg eCTD Ready Portugal IOR

Irbesartan + HCTZ Tablet - Film coated150mg + 12,5mg/ 300mg + 12,5mg and 300mg + 25mg

eCTD Ready Portugal IOR

Latanoprost Drops - Eye 50mg/ml eCTD In-Dev N / A IOR

Latanoprost + Timolol Drops - Eye 50mg/ml + 5mg/ml eCTD In-Dev N / A IOR

Leflunomide Tablet - Film coated 10mg/ 20mg and 100mg eCTD In-Dev N / A IOR

TECHNIMEDE

51




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Letrozole Tablet - Film coated 2,5mg eCTD Ready Portugal IOR

Levetiracetam Tablet - Film coated 250mg/ 500mg/ 750mg and 1000mg eCTD Ready Portugal IOR

Levetiracetam Solution - Oral 100mg/ml (300ml) eCTD Ready Portugal IOR

Levodopa + Carbidopa + Entecapone Tablet - Film coated

50mg + 12,5mg + 200mg/ 75mg + 18,75mg + 200mg/ 100mg + 25mg + 200mg/ 125mg + 31,25mg + 200mg/ 150mg + 37,5mg + 200mg and 200mg + 50mg + 200mg


Levofloxacin Tablet - Film coated 5mg/ml eCTD Ready Portugal IOR

Levofloxacin Injection - Solution eCTD Ready Portugal IOR

Losartan Tablet - Film coated 50mg and 100mg eCTD Ready Portugal IOR

Losartan + HCTZ Tablet - Film coated50mg + 12,5mg/ 100mg + 12,5mg and 100mg + 25mg


Memantine Tablet - Film coated 10mg eCTD Ready Portugal IOR

Memantine Tablet - Film coated 5mg/ 10mg/ 15mg and 20mg eCTD In-Dev N / A IOR

Midazolam Injection - Solution 15mg/3ml and 50mg/10ml eCTD In-Dev N / A IOR

Mirtazapine Tablet - Film coated 15mg/ 30mg and 45mg eCTD Ready Portugal IOR

Montelukast Tablet - Film coated 10mg eCTD Ready Portugal IOR

Montelukast Tablet - Chewable 4mg and 5mg eCTD Ready Portugal IOR

Mycophenelate Mofetil Tablet - Film coated 250mg and 500mg eCTD Ready Portugal IOR

Olanzapine Tablet - Film coated 5mg/ 7,5mg and 10mg eCTD Ready Portugal IOR

Ondansetron Injection - Solution 8mg/4ml eCTD Ready Portugal IOR

Oxcarbazepine Tablet - Film coated 300mg and 600mg eCTD Ready Portugal IOR

Pantoprazol Tablet - Gastro resistant 20mg and 40mg eCTD Ready Portugal IOR

Pantoprazol Injection - Powder 40mg eCTD In-Dev N / A IOR

Paracetamol Injection - Solution 10mg/ml eCTD Ready Portugal IOR

Pioglitazone Tablet 15mg/ 30mg and 45mg eCTD Ready Portugal IOR

Pioglitazone + Metformin Tablet - Film coated 15mg + 850mg eCTD In-Dev N / A IOR

Pravastatin Tablet 10mg/ 20mg and 40mg eCTD Ready Portugal IOR

TECHNIMEDE

52




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Pregabalin Capsule300mg/ 225mg/ 200mg/ 150mg/ 100mg/ 75mg/ 50mg and 25mg


Ranitidine Tablet - Film coated 150mg and 300mg eCTD Ready Portugal IOR

Rosuvastatin Ca Tablet - Film coated 5mg/ 10mg/ 20mg and 40mg eCTD In-Dev N / A IOR

Sertraline Tablet - Film coated 50mg and 100mg eCTD Ready Portugal IOR

Sildenafil Tablet - Film coated 25mg/ 50mg and 100mg eCTD Ready Portugal IOR

Tamoxifen Tablet 10mg and 20mg eCTD Ready Portugal IOR

Terbinafine Tablet 250mg eCTD Ready Portugal IOR

Topiramate Tablet - Film coated 25mg/ 50mg/ 100mg and 200mg eCTD Ready Portugal IOR

Valacyclovir Tablet - Film coated 250mg/ 500mg and 1000mg eCTD Ready Portugal IOR

Valsartan Tablet - Film coated 40mg/ 80mg/ 160mg and 320mg eCTD Ready Portugal IOR

Valsartan + HCTZ Tablet - Film coated80mg + 12,5mg/ 160mg + 12,5mg/ 160mg + 25mg/ 320mg + 12,5mg and 320mg + 25mg


Zoledronic Acid Injection - Solution 5mg/100ml eCTD In-Dev N / A IOR

Zoledronic Acid Injection - Solution 4mg/5ml eCTD In-Dev N / A IOR

TECHNIMEDE

53



COUNTRYUnited Kingdom

CITYWrexham

COMPANY NAMEWockhardt

Wockhardt UK is a diverse pharmaceutical business and is a major supplier of healthcare products to the Retail Pharmacy, Hospital Pharmacy and Grocery sectors. A wholly owned subsidiary of Mumbai-based Wockhardt Ltd, thriving Export and Contract Manufac-turing Divisions are helping to contribute to the company’s growth.Core Sales Territory: Global Regulated MarketsCore Operation: API Manufacture, API Manufacture, Finished Dose Manufacture, Finished Dose Manufacture, Sales and Market-ing, Sales and Marketing, DistributionContact Person: Mr Sanjeev Gulati; Director of In-Licensing


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Acetylsalicylic Acid Tablet 75 mg, 100 mg CTD Ready IOR IOR

Aciclovir Injection - Powder 250 mg CTD Ready IOR IOR

Aciclovir Tablet 200 mg, 400 mg, 800 mg CTD Ready IOR IOR

Aciclovir Cream 0.05 CTD In-Dev N / A IOR

Alendronate / Alendronic Acid Tablet 70 mg CTD Ready IOR IOR

Allopurinol Tablet 100 mg, 300 mg CTD Ready IOR IOR

Amiloride Tablet 5 mg CTD Ready IOR IOR

Amitriptyline Solution - Oral 10mg/5ml, 25mg / 5ml, 50mg/5ml CTD In-Dev N / A IOR

Amitriptyline Tablet 10 mg, 25 mg, 50 mg CTD Ready IOR IOR

Amlodipine Tablet 5 mg, 10 mg CTD Ready IOR IOR

Amoxicillin Capsule 250 mg, 500 mg CTD Ready IOR IOR

Amoxicillin Injection - Powder 250 mg, 500 mg, 1000 mg CTD Ready IOR IOR

Amoxicillin + Clavulanic Acid Powder 500 mg + 100 mg, 1000 mg + 200 mg CTD Ready IOR IOR

Aqueous Cream Cream 100gm, 500gm CTD In-Dev N / A IOR

Aspirin Tablet - Gastro resistant 75mg CTD In-Dev N / A IOR

Aspirin Tablet 300mg CTD In-Dev N / A IOR

Atenolol Tablet 25 mg, 50 mg, 100 mg CTD Ready IOR IOR

Atenolol + Chlortalidone Tablet 50 +12.5 mg, 100 + 25 mg CTD Ready IOR IOR

Atropine Sulphate Tablet 600mcg CTD Ready IOR IOR

54




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Bendroflumethazide Tablet 2.5 mg, 5 mg CTD Ready IOR IOR

Cefotaxime Injection - Powder 500mg, 1 g, 2 g CTD Ready IOR IOR

Ceftazidime Injection - Powder 1 g, 2 g CTD Ready IOR IOR

Ceftriaxone Injection - Powder 1 g, 2 g CTD Ready IOR IOR

Cetirizine Tablet 10 mg CTD Ready IOR IOR

Cetirizine Solution - Oral 5mg/5ml CTD In-Dev N / A IOR

Chlorpromazine Solution - Oral 25mg/5ml CTD In-Dev N / A IOR

Ciprofloxacin Tablet 250 mg, 500 mg CTD Ready IOR IOR

Citalopram Tablet 10mg, 20mg, 40mg CTD In-Dev N / A IOR

Clomifene Tablet 50 mg CTD Ready IOR IOR

Clopidogrel Tablet - Film coated 75mg CTD In-Dev N / A IOR

Co-Amilofruse (Amiloride + Furosemide) Tablet 2.5 / 20 mg, 5 / 40 mg, 10 / 80 mg CTD Ready IOR IOR

Co-Amilozide (Amiloride + HCTZ) Tablet 2.5 / 25 mg, 5 / 50 mg CTD Ready IOR IOR

Co-Amoxiclav Injection - Powder 600mg, 1.2g CTD In-Dev N / A IOR

Co-Codamol (Codeine + Paracetamol) Capsule 8/500mg, 30 / 500 mg CTD Ready IOR IOR

Co-Codamol (Codeine + Paracetamol) Tablet 30/500mg CTD In-Dev N / A IOR

Co-Danthramer Solution - Oral 25/200 / 5ml, 75/100 / 5ml CTD In-Dev N / A IOR

Codeine Linctus Solution - Oral 15mg/5ml CTD In-Dev N / A IOR

Codeine Phosphate Tablet 15 mg, 30 mg, 60 mg CTD Ready IOR IOR

Co-Dydramol Tablet 10 / 500 mg CTD Ready IOR IOR

Co-Fluampicil (Flucloxacillin + Ampicillin) Capsule 250mg/250mg CTD Ready IOR IOR

Co-Fluampicil (Flucloxacillin + Ampicillin) Injection - Powder 500 mg CTD Ready IOR IOR

Co-Fluampicil (Flucloxacillin + Ampicillin) Suspension 250 mg / 5 ml CTD Ready IOR IOR

Colchicine Tablet 500 mg CTD Ready IOR IOR

Co-Tenidone Tablet 50mg / 12.5mg, 100mg / 25mg CTD In-Dev N / A IOR

Cyproterone Acetate Tablet 50 mg, 100 mg CTD Ready IOR IOR

Diamorphine Injection 5 mg, 10 mg, 30 mg, 100 mg, 500 mg CTD Ready IOR IOR

WOCKHARDT

55




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Diazepam Injection 10 mg in 2ml CTD Ready IOR IOR

Diazepam Tablet 2 mg, 5 mg, 10 mg CTD Ready IOR IOR

Diazepam Rectal tubes 2.5 mg, 5 mg, 10 mg CTD Ready IOR IOR

Dihydrocodeine Tablet 30 mg CTD Ready IOR IOR

Disodium Pamidronate Injection 15 mg in 1ml , 30mg in 2ml, 60mg in 4ml, 90mg in 6ml

CTD Ready IOR IOR

Dobutamine Injection 250 mg in 20 ml CTD Ready IOR IOR

Domperidone Tablet 10 mg CTD Ready IOR IOR

Donepezil HCl Tablet - Film coated 5 mg, 10 mg CTD In-Dev N / A IOR

Emulsifying Ointment Ointment 100gm, 500gm CTD In-Dev N / A IOR

Ephedrine Tablet 15 mg, 30 mg CTD Ready IOR IOR

Ergotamine + Cyclizine + Caffeine Tablet 2 mg + 50 mg + 100 mg CTD Ready IOR IOR

Erythromycin (EES) Suspension 125 mg / 5 ml, 250mg / 5ml, 500mg / 5ml CTD Ready IOR IOR

Ferrous Sulphate Tablet 200mg CTD In-Dev N / A IOR

Finasteride Tablet 5 mg CTD Ready IOR IOR

Flucloxacillin Injection - Powder 250mg, 500mg, 1g CTD In-Dev N / A IOR

Fluconazole Capsule 50 mg, 150mg, 200 mg CTD Ready IOR IOR

Fluoxetine Capsule 20 mg CTD Ready IOR IOR

Fluoxetine Solution - Oral 20mg / 5ml CTD In-Dev N / A IOR

Fluvoxamine Tablet 50 mg, 100 mg CTD Ready IOR IOR

Folic Acid (Vitamin B9) Solution - Oral 2.5 mg / 5 ml CTD Ready IOR IOR

Folic Acid (Vitamin B9) Tablet 5mg CTD In-Dev N / A IOR

Furosemide Injection 250mg/25ml, 20 mg / 2 ml CTD Ready IOR IOR

Furosemide Solution - Oral 20mg/5ml, 40mg/5ml, 50mg/5ml CTD Ready IOR IOR

Furosemide Tablet 20 mg, 40 mg CTD Ready IOR IOR

Glibenclamide Tablet 2.5 mg, 5 mg CTD Ready IOR IOR

Gliclazide Tablet 80 mg CTD Ready IOR IOR

WOCKHARDT

56




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Haloperidol Solution - Oral 5mg/5ml, 10mg/5ml CTD In-Dev N / A IOR

Heartburn & indigestion liquid (sugar-free - Aniseed)

Suspension - Oral 500ml CTD In-Dev N / A IOR

Heartburn & indigestion liquid (sugar-free - Peppermint)

Suspension - Oral 500ml CTD In-Dev N / A IOR

Heparin Calcium Injection 5000 IU /0.2 ml CTD Ready IOR IOR

Heparin Sodium Injection 1,000 I.U./ml, 5,000 I.U./ml, 10,000 I.U./ml, 20,000 I.U./ml, 25,000 I.U./ml, 12,5000 I.U./ml

CTD Ready IOR IOR

Heparin Sodium Flush Solution Injection 50 IU, 200 IU CTD Ready IOR IOR

Hyaluronidase Injection - Powder 1500 IU CTD Ready IOR IOR

Hydrocortisone Cream 0.01 CTD In-Dev N / A IOR

Hydrocortisone Ointment 0.01 CTD In-Dev N / A IOR

Hyoscine Hydrobromide Injection 400mcg, 600mcg CTD Ready IOR IOR

Hypurin® Bovine Isophane Insulin Injection 100 IU/ml CTD Ready IOR IOR

Hypurin® Bovine Isophane Insulin Injection - Cartridge 100 IU/ml CTD Ready IOR IOR

Hypurin® Bovine Lente Insulin Injection 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Bovine Neutal Insulin Injection 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Bovine Neutal Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Bovine Protamine Zinc Insulin Injection 100 IU/ml CTD In-Dev N / A IOR

Hypurin® NPH Insulin, Pork Injection 100 IU/ml CTD Ready IOR IOR

Hypurin® Porcine 30/70 Mix Insulin Injection 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Porcine 30/70 Mix Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Porcine Isophane Insulin Injection 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Porcine Isophane Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Porcine Neutral Insulin Injection 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Porcine Neutral Insulin Injection - Cartridge 100 IU/ml CTD In-Dev N / A IOR

Hypurin® Regular Insulin, Pork Injection 100 IU/ml CTD Ready IOR IOR

WOCKHARDT

57




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Ibuprofen Tablet 200 mg, 400 mg CTD Ready IOR IOR

Ibuprofen Caplet 200mg CTD In-Dev N / A IOR

Ibuprofen Suspension - Oral 100mg/5ml CTD In-Dev N / A IOR

Ketoconazole Shampoo 0.02 CTD In-Dev N / A IOR

Ketoprofen Gel 2.5% CTD In-Dev N / A IOR

Levothyroxine Tablet 25mcg CTD Ready IOR IOR

Loperamide Capsule 2mg CTD In-Dev N / A IOR

Loratadine Syrup 5mg/5ml CTD In-Dev N / A IOR

Metformin Tablet 500 mg, 850 mg CTD Ready IOR IOR

Methadone Injection 10 mg/ml CTD Ready IOR IOR

Midazolam Injection 2 mg/ml CTD Ready IOR IOR

Mirtazapine Tablet 15 mg, 30 mg, 45 mg CTD Ready IOR IOR

Mirtazapine Tablet - Dispersible (ODT) 15 mg, 30 mg, 45 mg CTD In-Dev N / A IOR

Morphine Sulphate Injection 10 mg/ml, 15 mg/ml, 30 mg/ml CTD Ready IOR IOR

Mycophenelate Mofetil Tablet - Film coated 500 mg CTD In-Dev N / A IOR

Naloxone Injection 400mcg CTD Ready IOR IOR

Naproxen Tablet 250 mg, 500 mg CTD Ready IOR IOR

Nitrazepam Tablet 5 mg CTD Ready IOR IOR

Norethisterone Tablet 5 mg CTD Ready IOR IOR

Ondansetron Tablet 4 mg, 8 mg CTD Ready IOR IOR

Ondansetron Injection 4 mg / 2 ml, 8 mg / 4 ml CTD Ready IOR IOR

Oxycodone HCl Injection 10 mg/1ml, 20mg/2ml CTD Ready IOR IOR

Pantoprazol Tablet - Gastro resistant 20 mg, 40 mg CTD Ready IOR IOR

Paracetamol Tablet 500 mg CTD Ready IOR IOR

Paracetamol Caplet 500mg CTD In-Dev N / A IOR

Paracetamol Capsule 500mg CTD In-Dev N / A IOR

Paracetamol Elixir 120mg/5ml CTD In-Dev N / A IOR

WOCKHARDT

58




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Paracetamol Suspension - Oral 120mg/5ml, 250mg/5ml CTD In-Dev N / A IOR

Paracetamol + Caffeine Tablet 500mg/65mg CTD In-Dev N / A IOR

Phenytoin Tablet 100 mg CTD Ready IOR IOR

Pholcodine Linctus Solution - Oral 5mg/5ml, 10mg/5ml CTD In-Dev N / A IOR

Piperacillin + Tazobactam Injection 2 g + 0.25 g, 4 g + 0.5 g CTD Ready IOR IOR

Prednisolone Tablet 1 mg, 5 mg CTD Ready IOR IOR

Propylthiouracil Tablet 50 mg CTD Ready IOR IOR

Protamine Sulphate Injection 50mg/5ml CTD Ready IOR IOR

Pyridoxine Tablet 500mg CTD In-Dev N / A IOR

Quinine Sulphate Tablet 300 mg CTD Ready IOR IOR

Risperidone Suspension - Oral 1 mg/ml CTD Ready IOR IOR

Risperidone Tablet - Film coated 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg CTD Ready IOR IOR

Ropinirole Tablet - Film coated 0.25mg, 0.5mg, 1mg, 2mg, 5mg CTD In-Dev N / A IOR

Salbutamol Syrup 2mh/5ml CTD In-Dev N / A IOR

Sertraline Tablet 50 mg, 100 mg CTD Ready IOR IOR

Simple Linctus Solution - Oral 114.29mg/5ml, 125mg/5ml, 500mg CTD In-Dev N / A IOR

Simvastatin Tablet 10mg, 20mg, 40mg, 80mg CTD In-Dev N / A IOR

Sodium Citrate Micro-Enema Solution - Rectal 5ml CTD In-Dev N / A IOR

Sodium Valproate Tablet 200mg,500mg CTD In-Dev N / A IOR

Sodium Valproate Solution - Oral 200mg/5ml CTD In-Dev N / A IOR

Sulfadiazine Tablet 500 mg CTD Ready IOR IOR

Sulpiride Tablet 200 mg, 400 mg CTD Ready IOR IOR

Sumatriptan Tablet 50mg, 100mg CTD In-Dev N / A IOR

Tamoxifen Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR IOR

Tamsulosin Capsule - MR 400mcg CTD Ready IOR IOR

Terbinafine Tablet 250 mg CTD Ready IOR IOR

Timolol Drops - Eye 0.25%, 0.5% CTD In-Dev N / A IOR

WOCKHARDT

59




DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Timolol Solution - Eye 0.25%, 0.5% CTD In-Dev N / A IOR

Trimethoprim Suspension 50 mg / 5 ml CTD Ready IOR IOR

Ursodeoxycholic Acid Tablet 300 mg CTD Ready IOR IOR

Vancomycin Injection 500 mg, 1g CTD Ready IOR IOR

Venlafaxine Capsule - MR 75mg, 150mg CTD In-Dev N / A IOR

WOCKHARDT

60



COUNTRYGermany

CITYBöblingen

COMPANY NAMEWörwag

Wörwag R&D GmbH as affiliate of Wörwag Pharma has a focus on dossier development, registration and out licensing of generic / OTC drugs, predominantly anti diabetic, cardiovascular and CNS products. Core Sales Territory: Global Regulated MarketsCore Operation: Sales and Marketing Contact Person: Mrs Linda Strehle; Research & Development


DOSSIER STATUS

APPROVED COUNTRY

REGULATORY STATUS

Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD In-Dev N / ADCP underway (Oct 2010)

Candesartan + HCTZ Tablet8 mg + 12.5 mg, 16 mg + 12.5 mg, 32 mg + 12.5 mg, 32 mg + 25 mg

CTD In-Dev N / A DCP slot booked

Clopidogrel Tablet - Film coated 75 mg eCTD Ready Germany PLG

Donepezil Tablet - Film coated 5 mg, 10 mg eCTD Ready Germany PLG

Enalapril + HCTZ Tablet 20 mg + 12.5 mg CTD Ready Germany Approved

Galantamine Capsule - XR 8 mg, 16 mg, 24 mg CTD In-Dev N / A DCP slot booked

HCTZ (Hydrochlorothiazide) Tablet 12.5 mg, 25 mg CTD Ready Germany Approved

Levetiracetam Tablet - Film coated 250 mg, 500 mg, 750 mg, 1000 mg eCTD Ready N / ADCP underway (Sept 2010)

Losartan Tablet - Film coated 12.5 mg, 25 mg, 50 mg, 100 mg CTD Ready Germany PLG

Losartan + HCTZ Tablet - Film coated50 mg + 12.5 mg, 100 mg + 12.5 mg, 100 mg + 25 mg

CTD Ready Germany Approved

Pioglitazone Tablet 15 mg, 30 mg, 45 mg eCTD In-Dev N / ADCP underway (Oct 2010)

Silymarin Capsule 86.5 mg CTD Ready Germany PLG

Silymarin Capsule 86,5 mg CTD In-Dev N / A NRP

Torsemide Tablet 2.5 mg, 5 mg, 10 mg, 20 mg CTD Ready Germany Approved

Valsartan Tablet 40 mg, 80 mg, 160 mg, 320 mg CTD Ready Germany DCP underway

Xipamide Tablet 10 mg, 20 mg, 40 mg CTD Ready Germany Approved

Give us a brief >> We agree a list of companies & products >>

We get a licensing offer from them >> You take it from there

[email protected]

WE'LL DO THE WORK!TAKE THE EFFORT OUT OF IN-LICENSING

www.findapharma.com

� Regulatory filings, variations and license maintenance

� Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA)

� Manufacturing GMP inspection preparation

� Manufacturing technical transfers

� Formulation development projects

Europe – North America – AustralasiaExpertise is offered both in-house and through industry leading partners.

Talk to us about your technical service requirements today.

CALL +44 (0)845 453 1376+1 (646) 374 4234

[email protected] dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.

Services Offered