Acme

Gro

up

2008Hormonal Production

Facility added

Evo

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Acme is a leading provider of Contract Manufacturing and Development services to the pharmaceutical industry for Oral Solid and Sterile dosage form. Acme began its journey in 2005 and in a decade has transformed into a trusted partner and a complete solution provider. The Group has expanded into niche segments of Oral Hormones, both Sex Hormones and Levothyroxine, along with General Injectables - Liquids and Lyophilized, catering through three state-of-the-art manufacturing facilities.

Today it employs more than 2000 highly-skilled workforce at its facilities which are located in Northern India. The facilities are

spread over an area of approx 500,000 sq ft having an annual capacity of 15 Billion Tablets, 3 Billion Capsules and 42 Million Ampoules / Vials.

In our journey over the past decade we have been audited and approved by various international regulatory agencies including UK-MHRA, EU-GMP, ANVISA, PICS, INVIMA, WHO-Geneva. Apart from this the Group has approvals across major countries in Asia, Africa, CIS and Latin Countries. US FDA filing is planned for Q2, 2018 as we continue our journey towards building a sustainable future.

At Acme we offer Quality, Speed and Value by combining our technical competencies and cost effective solutions. Across our sites our development teams are proficient in

Analytical Development: Method development and Validation

Pre-Formulation Studies: Chemical / physical characterization and Drug / Excipient compatibility

Formulation Development

Stability Studies: Stability testing, Container closure compatibility, Storage at all Major ICH conditions

Manufacturing and Supply

With an invesment in excess of USD 150 million, Acme proudly serves more than 25 customers including many of the world’s leading companies. With an unwavering focus on Service and Quality, Acme is strategically positioned to serve as a preferred business partner.

2005First OSD Facility

Commences Operations

2010In-house

R&D Centre started

2012New Sterile FDF

Facility added

EU-GMP/ UKMHRA/ ANVISA /PICS approval received.

New R&D Centre atBangalore commences operations

2016 2017TGA Australia

Approval

New OSDFacility added

2014 2015WHO Geneva Pre Qualification/

INVIMA approval received

2018Q1 filling USA

2000 Highly Skilled Staff

500,000 sq. ft. area across 3 Facilities

Multi Dosage & Complex Pharmaceutical Products Dedicated Facilities

Exclusively focused on CMO as well as Risk Reward Partnership Models

Oral Solid Dosage (Tablets & Capsules) in General Category

Dedicated Female Sex/ Levothyroxine Hormone/Tablets Suite

Liquid & Lyophilized Injections

Serving Top 25 Indian Pharmaceutical Companies & 5 Global MNCs

Exporting to 40+ Countries in 3 continents

Contract Development Solid Orals, Liquids, Topicals, Opthalmics, Parenterals, Oncology

Capacity 15 Billion Tablets, 3 Billion Capsules, 30 million ampoules, 12 million lyophilized vials

International Accreditations WHO GENEVA / PICS/ INVIMA / UK MHRA/ ANVISA/US FDA*

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ine

nc

e

ORAL SOLID

DOSAGE

FACILITY

General

(Tablets/Capsules)

Levothyroxine

Tablets

EU-GMP

Approved

ORAL SOLID

DOSAGE FACILITY

General

(Tablets/Capsules)

Female Sex

Hormones

(Tablets)

WHO Geneva

pre-qualified

STERILE FDF

FACILITY

General

Liquid Injections

(Ampoules & Vials)

Lyophilized

(Vials)

UK MHRA/

ANVISA/PICS

Approved

R&D CENTER

Complex/Innovative

Generic Drug

Development

Capabilities

Oncology / High

Potency/Opthalmics/

Oral Solids/

Oral Liquids/

Dermatology

ACME FORMULATION

Solid Dosage Facility(GENERAL AND HORMONAL CATEGORY)

Tablets & CapsulesAvailable Dosage

Approvals WHO-Geneva, Tanzania, Nigeria, Ethiopia Ghana, Kenya, Yemen, Zimbabwe, Vietnam, Philippines, Zambia, Mozambique, Niger, Senegal, Sierra leone.

Capacity 3.5 Billion Tablets & 0.5 Billion capsules per annum

75000 sq. ft.Facility area

Gen

esis

IMMACULE LIFESCIENCES

New Sterile Facility (Liquid Injections & Lyophilized Vials)

Available Dosage Liquid Injections (Vials and Ampoules) & Lyophilized Vials

Approval UK-MHRA, ANVISA, INVIMA, PICS, TGA Australia* & US FDA*

Capacity 30 Million Ampoules / Vials & 12 Million Lyophilized Vials

Facility area 1,00,000 Sq. ft.

Ris

ing

* Filing scheduled in Q1 2018

VERITAS RESEARCHVeritas Research is a leading Research and Development Company with a team of over 30 professionals.With sound processes and systems in place including: QMS with well defined SOP's/ Plan/ Policy & Quality Manual, Validated metric management & IQA, Compliance to GCP, GLP, ISO standards & CFR Part 11 requirements, we are well entrenched to take your product from the idea to the commercializa�on stage.

Generic Drug Development (US, EU, Lat-AM and others) Solid Orals - IR, MR Tablets / Capsules Liquid orals - Solutions, Suspensions, Dry Syrups Topicals - Ointments/ Creams / Gels Ophthalmics – Suspension / Ointments / Solutions Parenterals - Liquid Injections – Vials, Ampoules, PFS,

Innovative Generics [505 (B) (2)] Fixed dose combination immediate release tablets/capsules Fixed dose combination extended release capsules

Inn

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Innovative Drug Delivery Technologies• Effervescent Formulation (Lubrication optimizations studies)• Tablet in Tablet Formulation (Compression coating)• Novel drug delivery systems including LiposomesDedicated Oncology / High Potency Products Area with Isolators• Dermatology product development Labs• Process Development Laboratories• Process Scale Up Facilities• Analytical Testing Laboratories• ICH Stability Chambers• In-vitro binding

ACME GENERICS

New Solid Dosage Facility (General Tablets/Capsules and Levothyroxine Tablets)

Available Dosage Tablets & Capsules

Approvals EU-GMP Hungary, TGA Australia. US-FDA *

Capacity 6 Billion Tablets from Levothyroxine Block. 10 Billion Tablets and 2 Billion Capsules from General Block

Facility area 300000 Sq. ft.

Mo

me

ntu

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* Filing scheduled in Q1 2018

Accre

dit

ati

on

s

NIGERIA

NAFDAC

COLOMBIA

GHANA

TANZANIA

National Drug Authority

UGANDA

Direction de la Pharmacie, du Médicamentet des Laboratoires de Côte d´lvoire

IVORY COAST YEMEN FMHACA ETHIOPIA

ZIMBABWE

MC AZ

KENYA

UKRAINE

HUNGARY

UK

WHOBRAZIL

ANVISA

VIETNAM

YTỘ ÊB

PHILIPPINES

SIERRA LEONE

MINISTRY OF HEALTH & SANITATION

MINISTÈRE DE LA SAMTÉ ETDE L’ACTION SOCIALE

SENEGAL ZAMBIA

AUSTRALIA

Australian Government

Department of Health and Ageing

Cre

ati

onProduct Development Injectable

S.No. Name of Product RLD Nature of Product Ampoule/ Vials12345

678

910111213141516171819202122

23

24

Esomeprazole InjectionEssential Phospholipid InjectionKetorolac InjectionOmeperazole InjectionOndansetronOxytocinPantaprazole InjectionRabeprazole InjectionRocuronium Bromide Injection0.9% Sodium Chloride Injection5% Sodium Bicarbonate InjectionTranexamic Acid Injection 100 mg/ml(5ml)Tranexamic Acid Injection 100 mg/ml(10ml)Vancomycin Injection(500mg)

Vancomycin Injection(1000mg)

Voriconazole Injection

AcyclovirAzithromycin InjectionCaspofungin 50mg/ 70 mgClarithromycin InjectionCiticholine Injection 250 mg/ml(2ml/4ml)Preservative FreeColistithemate Sodium Injection 1 M IU/VialColistithemate Sodium Injection 2 M IU/VialCyanocobalamin

ZoviraxZedbac,ZithromaxCancidasKlaricidNA

ColomycinColomycinCynocobalamin-American ReagentNexiumEssentialeKetorolac TrometamolOmeprazole MylanZofranSyntocinonProtium, ProtonixRabelocZemuronSodium ChlorideSodium BicarbonateCyklokapronCyklokapronVanocin,Vancomycin FreseniusVanocin,Vancomycin FreseniusVfend

LyophilizedLyophilizedLyophilizedLyophilizedLiquid

LyophilizedLyophilizedLiquid

LyophilizedLiquidLiquidLyophilizedLiquidLiquidLyophilizedLyophilizedLiquidLiquidLiquidLiquidLiquidLiquid

Lyophilized

Lyophilized

VialsVialsVialsVialsAmpoules

VialsVialsAmpoules

VialsAmpoulesVialsVialsAmpoulesAmpoulesVialsVialsVialsAmpoulesAmpoulesAmpoulesVialsVials

Vials

Vials

Product Development Solid Oral

S.No. Name of Product RLD Nature of Product Tablets12345678

Carbimazole 5 & 20mgDapsone 50,100mgLevothyroxineLevothyroxine Oral SolutionLiothyronin 20mcgMethocarbamol 750mgMetformin SR 500,750, 1000mgPropylthiouracil 50mg

CarbimazoleDapsoneEltroxin/LevothyroxineLevothyroxineTertroxin/Liothyronin NaMethocarbamolGlucophage SRPropylthiouracil

SolidSolidSolidSolidSolidSolidSolidSolid

TabletTabletTabletTabletTabletTabletTabletTablet

GYNAECOLOGY & FEMALE HORMONAL PRODUCTS

Levonorgestrel Tablets 0.75mg/1.5mg AvailableMifepristone Tablets 200mg AvailableMisoprostol Tablets 200mcg/100mcg /25mcg Available

Lyophilized Injections

Esomeprazole 40mg AvailablePantoprazole 40mg AvailableOmeprazole Inj. 40 mg AvailableRabeprazole 20mg AvailableClarithromycin 500mg AvailableAzithromycin 500mg AvailableVoriconazole Inj. 100mg AvailableAcyclovir Inj. 500mg/ 1g Q2 2018Vancomycin 500mg, 1000mg AvailableTeicoplanin 400mg Q2 2018Tigecycline 50mg Q2 2018Multivitamin B1-20mg,B2-5mg, B3-40mg,B6-5mg, B12-103mcg Q1 2018Caspofungin 50mg/70mg AvailableColistithemate Sodium Inj. 1 M IU/Vial & 2M IU/ Vial Under Development

THYROID MANAGEMENT

Levothyroxine Tablets 12.5/25/50/75/ 88/100/ 112/125/ 137/150/200/ 300 mcg AvailableLevothyroxine Oral Solution Under Development

Liothyronin 5mcg, 20mcg, 25mcg, 50mcg Under DevelopmentPropylthiouracil 50mg Under DevelopmentCarbimazole Tablets 5/10/20 mg Under Development

ANTIDIABETIC

Acarbose Tablets 25/50mgGlibenclamide Tablets 2.5/5mg Tech PackGlibenclamide & Metformin HCl Tablets 5/500mg AvailableGliclazide Tablets 80mg Tech PackGliclazide & Metformin Tablets 80/500mg Tech PackGlimepiride Tablets 1/2/3/4mg AvailableGlimepiride & Metformin HCl SR Tablets 1+500mg & 2+500mg AvailablePioglitazone Tablets 15/30mg Q4 2017Pioglitazone & Metformin HCl Tablets 15+500mg & 30+500mg Tech PackPioglitazone & Glimepiride Tablets 15+1mg & 15+2mg Tech PackVoglibose Tablets 0.2/0.3mg Tech PackVoglibose & Metformin Tablets 0.2+500mg & 0.3+500mg Tech PackVoglibose,Metformin & Glimepiride Tablets 0.2+500+1mg & 0.2+500+2mg Metformin SR Tablets 500mg SR/ 750 SR/1000mg SRMetformin Hydrochloride Tablets 500 mg Available

CENTRAL NERVOUS DRUGS

Zolpidem Tartrate E.R Tablets 6.25/12.5mgMethocarbamol Tablets 750 mg Under DevelopmentDothiepin HCl Tablets 25/50/75mgAlprazolam Tablets 0.25/0.50mgClonazepam Tablets 0.25/0.50mgZolpidem Tablets 5/10mgCinitapride Tablets 1mgLevetiracetam Tablets 250mg/500 mg AvailableLacosamide Tablets 50/100/150/200mg

ANALGESICS/PAIN MANAGEMENT

Paracetamol Tablets 500/650 mg Tech PackParacetamol +Caffeine Tablets 650+32.5 mg Tech PackParacetamol+Dicylcomine Tablets 500+20mg Tech PackIbuprofen+Paracetamol+Caffeine TabletTramadol Hydrochioride Capsules 50mg AvailableTramadol Hydrochioride & Paracetamol Tablets 37.5+325 Q1 2018Ibuprofen & Paracetamol Tablets 400+325mg Tech PackDiclofenac Sodium S.R. Tablets 100mg Tech PackDiclofenac Potassium Tablets 50 mg Tech PackDiclofenac Sodium & Paracetamol Tablets 50+325 mg/50+500mg AvailableDicloefenac Potassium & Thiocolchicoside Tablets 50 mg & 4 mg Tech PackThiocolchicoside Capsules 4mg/8mg Tech Pack

STERILE PORTFOLIO

Liquid Injections

Rocuronium Bromide Injection 50mg AvailableCyanocobalamin 1ml, 10ml,30ml Under DevelopmentTranexamic Acid Ampoules 100 mg/ml(5ml) AvailableTranexamic Acid Vials 100 mg/ml(10ml) AvailableEssential Phospolipids Ampoules AvailableCiticholine Inj 250mg/ml AvailableKetorolac Injection 30mg Q1 2018Ondansetron Injection 4mg/8mg Q1 20180.9% Sodium Chloride Injection 0.90% Under Development5% Sodium Bicarbonate Injection 5% Under DevelopmentOxytocin Injection Under Development

Comb kit one Mifepristone, Four Misoprostol Tablets 200mg+200mcg AvailableTranexamic Acid & Mefenamic Acid Tablets 500+250mg Tech PackNorethisterone Tablets 5mg Q1 2018Tranexamic Acid Tablets 500 mg Available

CARDIOVASCULAR DRUGS/HYPERTENSION

Atenolol Tablets 25/50/100mg AvailableAtenolol & Amlodipine Tablets 50+5mg Tech PackAtenolol and Chlorthalidone Tablets 50+12.5 /100+25 mgRamipril Capsules/Tablets 2.5/5/10mg AvailableLosartan Potassium Tablets 25/50mg AvailableLosartan Potassium & Hydrochlorothiazide Tablets 50+12.5mg AvailableLosartan Potassium & Amlodipine Tablets 50+5mg & 25+2.5mg Tech PackLosartan Potassium & Ramipril Tablets 50/2.5 mg + 50/5 mg Tech PackAmlodipine Tablets 5/10mg AvailableOlmesartan Medoxomil Tablets 5/20/40mg Q1 2018Olmesartan Medoxomil & HCTZ Tablets 20+12.5mg & 40+25mg Q1 2018Olmesartan + Amlodipine Tablets 20+5 mg & 40+5 mg Tech PackOlmesartan + Chlorthalidone Tablets 20+12.5mg & 40+12.5mg Tech PackTelmisartan Tablets 20/40/80mg AvailableTelmisartan + Chlorthalidone Tablets 40/12.5mg & 40/6.25mg & 80/12.5mg Tech PackTelmisartan and HCTZ Tablets 40/80 and 12.5 mg Q1 2018Atorvastatin Tablets 10/20/80mg AvailableAtorvastatin + Aspirin Capsules 10/75 mg & 10/150 mg Q1 2018Atorvastatin + Aspirin + Ramipril Capsules 10/75/5 mg Atorvastatin & Ezetimibe Tablets 10+10mg Q1 2018Bisoprolol Tablets 5/10mg AvailableBisoprolol & HCTZ Tablets 2.5/6.25 & 5/6.25 Tech PackBisoprolol + Amlodipine Tablets 2.5+5mg/ 5+5mg Tech PackClopidogrel tablets 75 mgCilnidipine Tablet 5/10/20 mg Tech PackCilnidipine +Telmisartan Tablets 10+40 mg Tech PackPravastatin Tablets 10 mg Q4 2017

Product List Emerging Market

ANTIBIOTICS

Azithromycin DT Tablets 50/100mgAzithromycin Tablets 250/500/1000mg AvailableRoxithromycin Tablets 150mgSparfloxacin Tablets 200mgOfloxacin Tablets 100/200/400mg Tech PackOfloxacin & Ornidazole Tablets 200+500mg Tech PackOfloxacin & Tinidazole Tablets 200+600mgCiprofloxacin HCl Tablets 250/500mg AvailableCiprofloxacin HCl & Tinidazole Tablets 500+500mg Q1 2018Fluconazole, Azithromycin & Secnidazole Tablets Combikit 150+1000+1000mg AvailableFluconazole & Tinidazole Tablets Combikit 150+1000mgGatifloxacin Tablets 200/400mgLevofloxacin Tablets 250/500mg Q4 2017Ornidazole Tablets 500mgTinidazole Tablets 500mg AvailablePrulifloxacin Tablets 600mgGemifloxacin Mesylate Tablets 320mgBalofloxacin Tablets 100mgClarithromycin Tablets USP 500mgLinezolid Tablets 600 mg Q1 2018Metronidazole Tablets 500 mg

ANTIFUNGALS

Fluconazole 50 DT Tablets 50mgFluconazole Tablets/Capsules 150mg AvailableFluconazole Tablets 200 mg AvailableItraconazole Capsules 100mg AvailableClotrimazole Tablets 100mg

ANTACIDS/GASTROLOGY/ANTIVERTIGO

Omeprazole & Sodium Bicarbonate Tablets 20+1100mg & 40+1100mgRabeprazole Sodium Tablets 20mg AvailableRabeprazole Sodium & Domperidone SR Capsules 20+30mg Tech PackRabeprazole & Levosulpiride SR Capsules 20+75mg SR Tech PackMagaldrate & Simethicone Tablets 400+20mgEsomeprazole Tablets 20/40mg AvailableEsomeprazole & Domperidone Capsules 20+30mg ( SR) Tech PackEsomeprazole & Levosulpiride SR Capsules Tech PackOmeprazole Capsules 10/20mg AvailableOmeprazole & Domperidone Capsules 20+10mg Tech PackLansoprazole Capsules 30mg AvailableOmeprazole & Domperidone SR Capsules 20+30mg Tech PackPantoprazole EC Tablets 20/40mg AvailablePantoprazole & Domperidone Capsules 20+10mg Tech PackPantoprazole + Itopride Capsules 40+150mg Tech PackRabeprazole Sodium & Sodium Bicarbonate as buffer Tablets 20+1100mg /40+1100mgPantoprazole Sodium with Sodium Bicarbonate as buffer Tablets 20+1100mg /40+1100mgDomperidone Tablets 10mg Tech PackDexrabeprazole Sodium Enteric Coated Tablets 5/10mgBalsalazide Disodium Dihydrate Capsules 750mg Tech PackLevosulpiride Tablets 25mg Tech PackLevosulpiride SR Tablets 75/100/150/200mg Tech PackLafutidine Tablets 5mg/10ng Tech PackOndansetron Tablets 4/8 mg Tech PackRanitidine Tablets 150 mgBetahistine Tablets 4/8/16 mg Q4 2017Albendazole Tablets 400mg Q1 2018

Etoricoxib Tablets 60/90/120mg AvailableEtoricoxib + Thiocolchicoside Tablets 60+4mg/ 60+8mg AvailableDiclofenac Sodium,Chlorzoxazone & Paracetamol Tablets 50,250 and 500 Tech PackDiclofenac Potassium,Chlorzoxazone & Paracetamol Tablets 50,250 and 325 mg Tech PackAceclofenac Tablets 100mg AvailableAceclofenac & paracetamol Tablets 100+500mg AvailableAceclofenac (S.R) Tablets 200mg Tech PackAceclofenac, Paracetamol & Serratiopeptidase Tablets 100+500+10mg Tech PackAceclofenac +Thiocolchicoside Tablets 100+4mg/100+8mg Tech PackDiacerein Capsules 50mg Tech PackLornoxicam Tablets 4/8mg AvailableLornoxicam & Paracetamol Tablets 4+500mg & 8+500mgEtodolac SR Tablets 600mg Tech PackTapentadol SR Tablets 100/150/200mgTapentadol Tablets 50/75/100mg Tech PackDosulepin 25/75mg Tech PackCelecoxib Capsules 200 mgDicyclomine +Paracetamol tablets 20mg+500mg Tech PackAspirin Tablets 75 mg

HPYLORI KITS

Combikit of Clarithromycin/Tinidazole & Rabeprazole Tablets AvailableCombikit of Clarithromycin/Tinidazole & Esomeprazole Tablets Available

URINARY TRACT RELATED DRUGS

Alfuzosin ER Tablets 10mg AvailableTerazosin HCl Tablets 1/2/5mg Tech Pack

LIVER DRUGS

Ursodeoxycholic 150/300mg Q1 2018

ANTICOLD/ANTIALLERGIC

Cetrizine Dihydrochloride Tablets 10mg AvailableLevocetrizine HCl Tablets 5mg AvailableLevocetirizine & Montelukast Sodium Tablets 5+10mg & 4+2.5mg Q1 2018Montelukast Sodium Tablets 4/5/10mg AvailableLevocetrizine Dispersible Tablets 5mgFexofenadine Hydrochloride Tablets 120/180 mg Q1 2018Loratadine Tablets 10 mg Q4 2017

VITAMINS & IRON SUPPLEMENTS

Ferrous Fumurate (equ. to El. Iron) & Folic Tablets 50+0.5mgFerrous Fumurate (equ. to El. Iron 50mg), Folic Acid 0.5mg & Elemental Zinc 20mg Tablets 50+0.5+20mgFolic Acid Tablets 5mg AvailableFerrous Ascorbate (eq. to elemental iron) & Folic Acid Tablets 50+1.5mg & 100+1.5mgFerrous Ascorbate (equ. To elemental iron), Folic Acid & El. Zinc Tablets 100+1.5+22.5mgMecobalamin Tablets 500mcg/1500 mcg Tech Pack

ENZYME

Serratiopeptidase Tablets 10mgTrypsin Chymotrypsin Tablets 50K/100K/200K Available Armour Unit

Acme Generics LLPPlot No. 115, HPSIDC Industrial AreaDavni, P.O. Gurumajra, Tehsil Nalagarh,Distt. Solan (H.P.) - 174 101Board Lines : +91 1795-332601Direct Lines : +91 1795-332606E-mail : viral@acmegenerics.in

Immacule Lifesciences(P) Ltd. IndiaVillage Thanthewal, Ropar Road,Nalagarh, Distt. Solan (H.P.) - 174 101Mobile No. : +91 98160-62744Tel : +91 1795-331406E-mail : viral@immacule.in

Acme Formulation Pvt. Ltd.Ropar Road, Nalagarh,Distt. Solan (H.P.) - 174 101Mobile No. : +91 98160-62744Board Lines : +91 1795-308001Direct Lines : +91 1795-308006E-mail : viralshah@acmeformulation.com

Veritas Research Inc.75-A, 15th cross, 1st phase, J.P. Nagar, Bengaluru, Karnataka 560078Tel : +91 80-42627200Fax : +91 80-26640683www.veritasresearch.in

GIANT STRIDES TOWARDS A GLOBAL FOOTPRINT

Fo

otp

rin

t

ASIANepal, Sri Lanka, Philippines,Vietnam, Cambodia, Laos, Thailand, Yemen, Myanmar

NORTH AMERICAUS (Filing planned in Q1 2018), Canada

SOUTH ANERICABrazil, Colombia, Guatemala, Nicaragua,Paraguay, Uruguay, Chille, Costa Rica,Venezuela, Peru

EUROPEUnited Kingdom, Hungary

CISKazakhstan, Uzbekistan, Ukraine

ANZAustralia

AFRICAEthiopia, Nigeria, Ghana. Tanzania, Kenya, Uganda, Zambia, Malawi, Sierra Leone, Madagascar, Angola, Zimbabwe, Mozambique, Cameroon, Senegal, South Sudan