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Page 1: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY
Page 2: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY
Page 3: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

www.hasco-lek.pl

Page 4: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

4 I COMPANY PROFILE

Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience.

COMPANY PROFILE

Page 5: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

5 I COMPANY PROFILE

The company complies Europeanquality requirements; this is confirmedby following certifications:

> GMP (Good Manufacturing Practice) > GLP (Good Laboratory Practice), > PN–EN ISO 13845:2005 (Management System Certificate – Medical Devices) > PN-EN ISO 14001:2004 (Environmental Management System Certificate) > PN-EN ISO 22000:2006 (Food Safety System Certificate)

All quality certificates are obtained on a basis of strict audits and controls performed by relevant authorities according to the European Union requirements.

Please find some of our services below:> Contract Manufacturing> Pharmaceutical development> Formulation development according to customer’s requirements> Re-formulation of existing products> Manufacturing process development> Manufacturing of trial, technological, pilot batches> Development and production consultancy> Production process validation> Scale-up/technological transfer

Analytical services> development of analytical methods> validation and revalidation of analytical methods> quality control of API, bulk and finished products> microbiological and physical-chemical testing> Stability testing in different climate conditions (ICH, ongoing)

Additional services> Storage of product samples> Managing of the documents required to apply for Marketing Authorizations

Various products areavailable in 8 modern forms: > Syrups > Suspensions > Drops > Tablets > Ointments > Gels > Suppositories > Powders

Flexible Packaging Divisions: > Bulk > Unitary boxes with blisters > Bottles > Other forms per clients’ requests

Page 6: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

6 I LICENSE - OUT

A01AD02 - Benzydamine hydrochloride

Active ingredient / dosage - Benzydamine hydrochloride 1.5 mg/mlPackaging and form - Bottle of 30 g with dispenser (spray)ATC group - A01AD02Dossier Status - AvailableIndication - Anti-inflammatory, analgesic effect, anaesthetic, disinfectantClassification + reference product - Generic - Tantum Verde, liquid, AziendeChimiche Riunite Angelini Francesco

Active ingredient / dosage - Benzydamine hydrochloride 3.0 mg/mlPackaging and form - Bottle of 30 g with dispenser (spray)ATC group - A01AD02Dossier Status - AvailableIndication - Anti-inflammatory, analgesic effect, anaesthetic, disinfectantClassification + reference product - Generic - Tantum Verde, liquid, AziendeChimiche Riunite Angelini Francesco

A03AD02 - Drotaverine

Active ingredient / dosage - Drotaverine 40 mgPackaging and form - Box of 20, 40 tabletsATC group - A03AD02Dossier Status - AvailableIndication - Smooth muscle contractions related to bile ducts diseases, urinary tract diseases, supplementary in contractions of alimentary tract smooth muscles and gynecological disorders Classification + reference product - Well Established Use

Active ingredient / dosage - Drotaverine 80 mgPackaging and form - Box of 20 tabletsATC group - A03AD02Dossier Status - AvailableIndication - Smooth muscle contractions related to bile ducts diseases, urinary tract diseases, supplementary in contractions of alimentary tract smooth muscles and gynecological disorders Classification + reference product - Well Established Use

Alimentary tract and metabolism

Page 7: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

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A06AD11 - Lactulose

Active ingredient / dosage - Lactulose 5 g/10 mlPackaging and form - glass bottle of 150 ml, syrupATC group - A06AD11Dossier Status - AvailableIndication - Constipation, hepatic encephalopathyClassification + reference product - Well Established Use

A07AX03 - Nifuroxazide

Active ingredient / dosage - Nifuroxazide 100 mgPackaging and form - Box of 24 tabletsATC group - A07AX03Dossier Status - AvailableIndication - Acute and long-lasting diarrhea in bacterial infections of thealimentary tractClassification + reference product - Generic, Ercefuryl, tablets, 100 mg,Sanofi Synthelabo

Active ingredient / dosage - Nifuroxazide 200 mgPackaging and form - Box of 12 tabletsATC group - A07AX03Dossier Status - AvailableIndication - Acute and long-lasting diarrhea in bacterial infections of thealimentary tractClassification + reference product - Generic, Ercefuryl, tablets, 200 mg,Sanofi Synthelabo

A11CC03 - Cholecalciferol

Active ingredient / dosage - Cholecalciferol 0.5mg/1 mlPackaging and form - drops in glass bottle of 10ml, unit carton boxATC group - A11CC03Dossier Status - AvailableIndication - Vitamin deficiency (for babies)Classification + reference product - Well Established Use

Page 8: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

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A12AA20 - Calcium lactogluconate

Active ingredient / dosage - Calcium lactogluconate 29.40g/100 ml, Calcium lactobionate 6.40 g/100 mlPackaging and form - Bottle of 150 ml, syrupfour tastes available: banana / strawberry / orange / colaATC group - A12AA20Dossier Status - AvailableIndication - Fever of various origin, e.g. in flu, colds or other infectiousdiseases as well as in post-vaccinal reaction; headaches, throat and musclepains, toothachesClassification + reference product - Well Established Use

A12AA20 - Calcium lactogluconate

Active ingredient / dosage - Calcium lactogluconate 29.40g/100 ml, Calcium lactobionate 6.40 g/100 mlPackaging and form - Bottle of 150 ml, syrupWithout artificial colorants and flavoring substancesATC group - A12AA20Dossier Status - AvailableIndication - Fever of various origin, e.g. in flu, colds or other infectiousdiseases as well as in post-vaccinal reaction; headaches, throat and musclepains, toothachesClassification + reference product - Well Established Use

B03BB01 - Folic acid

Active ingredient / dosage - Folic acid 5 mgPackaging and form - Box of 30, 60, 90 tabletsATC group - B03BB01Dossier Status - AvailableIndication - Folic acid deficiency, anemiaClassification + reference product - Well Established Use

Active ingredient / dosage - Folic acid 15 mgPackaging and form - Box of 30, 60, 90 tabletsATC group - B03BB01Dossier Status - AvailableIndication - Folic acid deficiency, anemiaClassification + reference product - Well Established Use

Blood and blood forming organs

Page 9: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

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Cardiovascular system

C05BA03 - Heparin

Active ingredient / dosage - Heparin 250 i.u./gPackaging and form - tube of 35g, gelATC group - C05BA03Dossier Status - AvailableIndication - Topical supportive treatment of superficial Venous diseases: thrombophlebitis, varicose legs, swelling, contusions, hematomaClassification + reference product - Well Established Use

Active ingredient / dosage - Heparin 1000 i.u./gPackaging and form - tube of 35g, gelATC group - C05BA03Dossier Status - AvailableIndication - Topical supportive treatment of superficial Venous diseases: thrombophlebitis, varicose legs, swelling, contusions, hematomaClassification + reference product - Well Established Use

Active ingredient / dosage - Heparin 2400 i.u./gPackaging and form - tube of 30g, gelATC group - C05BA03Dossier Status - AvailableIndication - Topical supportive treatment of superficial Venous diseases: thrombophlebitis, varicose legs, swelling, contusions, hematomaClassification + reference product - Well Established Use

C05BX01 - Calcium dobesilate monohydrate

Active ingredient / dosage - Calcium dobesilate monohydrate 250 mgPackaging and form - Box of 30 tabletsATC group - C05BX01Dossier Status - AvailableIndication - Venous and lymphatic insufficiencyClassification + reference product - Generic, Doxium, 250 mg, tablets, OMPharma

Active ingredient / dosage - Calcium dobesilate monohydrate 500 mgPackaging and form - Box of 30 tabletsATC group - C05BX01Dossier Status - AvailableIndication - Venous and lymphatic insufficiencyClassification + reference product - Generic, Doxium, 500 mg, hard gelatin capsules OM Pharma

Page 10: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

10 I LICENSE - OUT

C05CA03 - Diosmin micronized

Active ingredient / dosage - Diosmin micronized 500 mgPackaging and form - Box of 30 or 60 tabletsATC group - C05CA03Dossier Status - AvailableIndication - Venous circulation failure, feeling of „heavy legs”Classification + reference product - Well Established Use

Active ingredient / dosage - Diosmin micronized 1000 mgPackaging and form - Box of 30 or 60 tabletsATC group - C05CA03Dossier Status - AvailableIndication - Venous circulation failure, feeling of „heavy legs”Classification + reference product - Well Established Use

C07AB07 - Bisoprolol fumarate

Active ingredient / dosage - Bisoprolol fumarate 5 mgPackaging and form - Box of 30 tabletsATC group - C07AB07Dossier Status - AvailableIndication - Hypertension, cardiac ischemiaClassification + reference product - Generic, Concor, tablets, 5mg, Merck KgaA

Active ingredient / dosage - Bisoprolol fumarate 10 mgPackaging and form - Box of 30 tabletsATC group - C07AB07Dossier Status - AvailableIndication - Hypertension, cardiac ischemiaClassification + reference product - Generic, Concor, tablets, 10mg, Merck KgaA

Page 11: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

11 I LICENSE - OUT

C09AA06 - Quinapril hydrochloride

Active ingredient / dosage- Quinapril hydrochloride 5 mgPackaging and form - Box of 30 tabletsATC group - C09AA06Dossier Status - AvailableIndication - ACE inhibitor, plainClassification + reference product - Generic, Accupro 5 mg, tablets, Pfizer Inc.

Active ingredient / dosage - Quinapril hydrochloride 10 mgPackaging and form - Box of 30 tabletsATC group - C09AA06Dossier Status - AvailableIndication - ACE inhibitor, plainClassification + reference product - Generic, Accupro 10 mg, tablets, Pfizer Inc.

Active ingredient / dosage - Quinapril hydrochloride 20 mgPackaging and form - Box of 30 tabletsATC group - C09AA06Dossier Status - AvailableIndication - ACE inhibitor, plainClassification + reference product - Generic, Accupro 20 mg, tablets, Pfizer Inc.

D07AD01 - Clobetasol 0,50 mg/g

Active ingredient / dosage - Clobetasol 0,50 mg/gPackaging and form - tube of 25g, ointmentATC group - D07AD01Dossier Status - AvailableIndication - Symptomatic treatment of skin diseases reacting to corticosteroids: psoriasis (excluding the generalized changes) ; lichen planus, systemic lupus erythematosus (SLE), recurrent eczema, skin diseases difficult to cure, unsuccessfully treated with milder corticosteroids. Classification + reference product - Well Established Use

Dermatologicals

Page 12: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

12 I LICENSE - OUT

G03AC05 - Megestrol acetate

Active ingredient / dosage - Megestrol acetate 40 mg / mlPackaging and form - Oral suspension in 240 ml glass bottleATC group - G03AC05Dossier Status - AvailableIndication - Treatment of anorexiaClassification + reference product - Generic, Megace, oral suspension, 40 mg / ml, Bristol-Myers Squibb

Genito-urinary system and sex hormones

G04CX02 - Saw palmetto fruit extr.

Active ingredient / dosage - Saw palmetto fruit extr. (serenoa repens) 160 mgPackaging and form - Box of 60 softgelsATC group - G04CX02Dossier Status - AvailableIndication - Mild prostate hypertrophy (pollakiuria, frequent urination at night, decrease of urinary flow, urine retention and painful ailments)Classification + reference product - Well Established Use

Page 13: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

13 I LICENSE - OUT

Antiinfectives for systemic use

J01XE - Furaginum

Active ingredient / dosage - Furaginum 50 mgPackaging and form - Box of 30, 60 tabletsATC group - J01XEDossier Status - AvailableIndication - Treatment of severe and recurrent lower urinary tract infections without complications.Classification + reference product - Well Established Use

Active ingredient / dosage - Furaginum 100 mgPackaging and form - Box of 15, 30 tabletsATC group - J01XEDossier Status - AvailableIndication - Treatment of severe and recurrent lower urinary tract infections without complications.Classification + reference product - Well Established Use

J05AB01 - Aciclovir

Active ingredient / dosage - Aciclovir 50 mg/gPackaging and form - tube of 5 g lipogel, unit carton boxATC group - J05AB01Dossier Status - AvailableIndication - Cold sores caused by herpes simplexClassification + reference product - Well Established Use

Active ingredient / dosage - Aciclovir 200 mgPackaging and form - Box of 30 tabletsATC group - J05AB01Dossier Status - AvailableIndication - Cold sores caused by herpes simplexClassification + reference product - Generic, Zovirax, 200 mg, tablets, Glaxo-Wellcome Group

Active ingredient / dosage - Aciclovir 400 mgPackaging and form - Box of 30 tabletsATC group - J05AB01Dossier Status - AvailableIndication - Cold sores caused by herpes simplexClassification + reference product - Generic, Zovirax, 400 mg, tablets, Glaxo-Wellcome Group

Active ingredient / dosage - Aciclovir 800 mgPackaging and form - Box of 30 tabletsATC group - J05AB01Dossier Status - AvailableIndication - Cold sores caused by herpes simplexClassification + reference product - Well Established Use

Page 14: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

14 I LICENSE - OUT

M01AC06 - Meloxicam

Active ingredient / dosage - Meloxicam 7,5 mgPackaging and form - Box of 10, 20, 30 tablets ODTATC group - M01AC06Dossier Status - AvailableIndication - Anti-inflammatory pain killing drug, used in bone and joint pain as well as muscle pain related to rheumatoid diseases and degenerative joint disease. Classification + reference product - Well established use

Active ingredient / dosage - Meloxicam 15 mgPackaging and form - Box of 10, 20, 30 tablets ODTATC group - M01AC06Dossier Status - AvailableIndication - Anti-inflammatory pain killing drug, used in bone and joint pain as well as muscle pain related to rheumatoid diseases and degenerative joint disease. Classification + reference product - Well established use

M01AE01 - Ibuprofen

Active ingredient / dosage - Ibuprofen 100 mg / 5 mlPackaging and form - Bottle 130 ml two tastes available: banana / raspberryATC group - M01AE01Dossier Status - AvailableIndication - Fever of various origin, e.g. in flu, colds or other infectious diseases as well as in post-vaccinal reaction; headaches, throat and muscle pains, toothachesClassification + reference product - Generic, Nurofen suspension, 0.01 g / 5ml, Boots Healthcare International

Active ingredient / dosage - Ibuprofen 200 mg / 5 mlPackaging and form - Bottle 100 ml, 130 ml - oral suspension two tastes available: banana / raspberryATC group - M01AE01Dossier Status - AvailableIndication - Fever of various origin, e.g. in flu, colds or other infectious diseases as well as in post-vaccinal reaction; headaches, throat and muscle pains, toothachesClassification + reference product - Generic, Nurofen susp., 0.02 g / 5ml, Boots Healthcare Int.

Musculo-skeletal system

Page 15: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

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Nervous system

N02BE51 - Paracetamol, Diphenhydramine hydrochloride

Active ingredient / dosage - Paracetamol 500 mg, Diphenhydramine hydrochloride 25mgPackaging and form - Box of 6, 12 tabletsATC group - N02BE51Dossier Status - AvailableIndication - Headache, bone and joint pain, muscle pain, toothache, menstruation pain, neuralgia, pain related to colds and flu, causing sleep problems.Classification + reference product - Well Established Use

N05AA02 - Levomepromazine

Active ingredient / dosage - Levomepromazine 25 mgPackaging and form - Box of 30, 50, 60, 100 tabletsATC group - N05AA02Dossier Status - AvailableIndication - Schizophrenia. Other mental illnesses and disorders with excitement, aggression or psychosis. Anxiety - in small dosages, singular dosage in the evening in sleep disorder. Treatment of chronic pain (e.g. in cancer), to prevent pain in monotherapy or in combination with other analgesic drugs.Classification + reference product - Well Established Use

M01AE01 - Lysine Ibuprofen

Active ingredient / dosage - Lysine Ibuprofen 684 mg (eqv. Ibuprofen 400mg)Packaging and form - Box of 15, 30 tabletsATC group - M01AE01Dossier Status - AvailableIndication - Severe headache in the course of migraine with or without aura. Tension headache. Various aches (back pain, toothache, muscle and joint ache, painful menstruation, neuralgia). Pain and fever in the course of colds and flu.Classification + reference product - Well established use

Page 16: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

16 I LICENSE - OUT

N05AB10 - Perazine

Active ingredient / dosage - Perazine 25 mgPackaging and form - Box of 20 tabletsATC group - N05AB10Dossier Status - AvailableIndication - Antipsychotic (psychosis, schizophrenia)Classification + reference product - Well Established Use

Active ingredient / dosage - Perazine 100 mgPackaging and form - Box of 30 tabletsATC group - N05AB10Dossier Status - AvailableIndication - Antipsychotic (psychosis, schizophrenia) Classification + reference product - Well Established Use

N05AL01 - Sulpride

Active ingredient / dosage - Sulpride 50 mgPackaging and form - Box of 24, 30, 60, 120 tabletsATC group - N05AL01Dossier Status - AvailableIndication - Severe chronic psychosis in schizophrenia, Chronic alcohol related psychosis, psychosomatic disorders, depressive disorders, migraine and dizziness of various etiology (e.g. Ménière’s disease), supplementary in treatment of alcohol dependenceClassification + reference product - Well Established Use

Active ingredient / dosage - Sulpride 100 mgPackaging and form - Box of 24, 30, 60, 120 tabletsATC group - N05AL01Dossier Status - AvailableIndication - Severe chronic psychosis in schizophrenia, Chronic alcohol related psychosis, psychosomatic disorders, depressive disorders, migraine and dizziness of various etiology (e.g. Ménière’s disease), supplementary in treatment of alcohol dependenceClassification + reference product - Well Established Use

Active ingredient / dosage - Sulpride 200 mgPackaging and form - Box of 24, 30, 60, 120 tabletsATC group - N05AL01Dossier Status - AvailableIndication - Severe chronic psychosis in schizophrenia, Chronic alcohol related psychosis, psychosomatic disorders, depressive disorders, migraine and dizziness of various etiology (e.g. Ménière’s disease), supplementary in treatment of alcohol dependenceClassification + reference product - Well Established Use

Page 17: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

17 I LICENSE - OUT

N05BB0I - Hydroxyzine

Active ingredient / dosage - Hydroxyzine 10 mgPackaging and form - Box of 30 tabletsATC group - N05BB0IDossier Status - AvailableIndication - Symptomatic treatment of anxiety in adults, symptomatic treatment of itchy skin, premedication before surgeryClassification + reference product - Well Established Use

Active ingredient / dosage - Hydroxyzine 25 mgPackaging and form - Box of 30 tabletsATC group - N05BB0IDossier Status - AvailableIndication - Symptomatic treatment of anxiety in adults, symptomatic treatment of itchy skin, premedication before surgeryClassification + reference product - Well Established Use

N05C - Valerian dry extract

Active ingredient / dosage - Valerian dry extract 60 mg, Hop dry extract 40 mg,Passiflora dry extract 40 mgPackaging and form - Box of 30 softgelsATC group - N05CDossier Status - AvailableIndication - Sedative, antidepressant, soothes, eases the process of falling asleepClassification + reference product - Herbal drug (local regulation)

N06BX03 - Piracetam

Active ingredient / dosage - Piracetam 1200 mgPackaging and form - Box of 10, 20, 30 tabletsATC group - N06BX03Dossier Status - AvailableIndication - PsychostimulantClassification + reference product - Well Established Use

Page 18: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

18 I LICENSE - OUT

R01BA52 - Paracetamol, Pseudoephedrine hydrochloride, Dextromethorphan hydrobromide

Active ingredient / dosage - Paracetamol 300 mg + Pseudoephedrine hydrochloride 30 mg+ Dextromethorphan hydrobromide 12 mgPackaging and form - box of 10 or 20 softgelsATC group - R01BA52Dossier Status - AvailableIndication - Anti-fever, flu and derivate states, sinus inflammatory, cold, cough, running nose, headache, muscle acheClassification + reference product - Well established use

R01BA52 - Triprolidine hydrochloride, Pseudoephedrine HCl, Dextromethorphan hydrobromide

Active ingredient / dosage - Triprolidine hydrochloride 1.25 mg, Pseudoephedrine HCl 30 mg, Dextromethor-phan hydrobromide 10 mgPackaging and form - Glass bottle 100 ml, with metal cap in a unitary boxATC group -R01BA52Dossier Status - AvailableIndication - Flu, colds, and other infections of the upper respiratory tract, anti-cough, in treatment of nasal mucous membrane swelling and watery nasal dischargeClassification + reference product - Well Established Use

R03DX03 - Fenspiride hydrochloride

Active ingredient / dosage - Fenspiride hydrochloride 2mg/mlPackaging and form - Glass bottle 150 ml, with metal cap in a unitary boxATC group -R03DX03Dossier Status - AvailableIndication - Symptomatic treatment (cough and expectoration) in inflammatory diseases of bronchi and lungs Classification + reference product - Well Established Use

R05DA09 - Dextromethorphan hydrobromide

Active ingredient / dosage - Dextromethorphan hydrobromide 30 mgPackaging and form - Box of 15 softgelsATC group - R05DA09Dossier Status - AvailableIndication - Acute, dry and hard cough of a different etiologyClassification + reference product - Well Established Use

R05DB13 - Butamirate

Active ingredient / dosage - Butamirate 7,5 mg/5 mlPackaging and form - Glass bottle of 100ml, 200 m with metal cap in a unitary boxATC group - R05DB13Dossier Status - AvailableIndication - Treatment of different types of coughClassification + reference product - Well Established Use

Respiratory system

Page 19: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

19 I LICENSE - OUT

R05CB06 - Ambroxol hydrochloride

Active ingredient / dosage - Ambroxol hydrochloride 30 mgPackaging and form - Box of 15, 30 tabletsATC group - R05CB06Dossier Status - AvailableIndication - Severe chronic lung and bronchi diseases, with disorder in mucus secretion and problems with its transportClassification + reference product - Generic (biowaiver), Mucosolvan, Boehringer Ingelheim International GmbH

Active ingredient / dosage - Ambroxol hydrochloride 60 mgPackaging and form - Box of 15, 30 tabletsATC group - R05CB06Dossier Status - AvailableIndication - Severe chronic lung and bronchi diseases, with disorder in mucus secretion and problems with its transportClassification + reference product - Generic (biowaiver), Mucosolvan, Boehringer Ingelheim International GmbH

Active ingredient / dosage - Ambroxol hydrochloride 30 mg/5 mlPackaging and form - Glass bottle of 150 ml, with metal cap in a unitary box, syrupATC group - R05CB06Dossier Status - AvailableIndication - Severe chronic lung and bronchi diseases, with disorder in mucus secretion and problems with its transportClassification + reference product - Generic (biowaiver), Mucosolvan, Boehringer Ingelheim International GmbH

Active ingredient / dosage - Ambroxol hydrochloride 15 mg/5 mlPackaging and form - Glass bottle of 150 ml, with metal cap in a unitary box, syrupATC group - R05CB06Dossier Status - AvailableIndication - Severe chronic lung and bronchi diseases, with disorder in mucus secretion and problems with its transportClassification + reference product - Generic (biowaiver), Mucosolvan, Boehringer Ingelheim International GmbH

R06AX13 - Loratadine

Active ingredient / dosage - Loratadine 10 mgPackaging and form - Box of 7, 10 softgelsATC group - R06AX13Dossier Status - AvailableIndication - Allergic inflammation of the nasal mucosa, chronic idiopathic urticariaClassification + reference product - Generic, Claritine, tablets, 10 mg, company Schering-Plough

Page 20: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

20 I PRIVATE LABEL

Product name - Ulgix BabyForm / packaging - Drops in 40 g bottlewith a pumpStatus - Medical device

Composition - Simethicone5 mg in 1 pump press

Action Removes and soothes intestinal colic and gases gathered in intesti-nes in infants

Product name - Ulgix Flatulence MaxForm / packaging - Box of 15 or 30 soft-gelsStatus - Medical device

Composition - Simethicone 240 mg

Action Acts 3 times more effectively than Ulgix Flatulence of the dosage80 mg simethicone

MEDICAL

DEVICE

Removal of excessive gathering of gases in the intestine - to be used ad hoc

Line of excellent products for digestive system, which successfully solve common and frequent alimentary disorders

Product name - Ulgix Flatulence SpeedForm / packaging - Oral powder in 2 g sachetStatus - Medical device

Composition - Simethicone160 mg in 1 sachet

Action Removes excessive gases gathered in intestines - it is enough to pour the powder on one’s tongue, no water needed

Product name - Ulgix FlatulenceForm / packaging - Box of 25, 50 or 100 softgelsStatus - Medical device

Composition - Simethicone 80 mg

Action Releases intestines from gases excessively gathered inside, acts against feeling of „fullness” in abdominal cavity, as an auxiliary agent is administrated before diagnostic tests (ultrasonography, radiography and endoscopy)

Product name - Ulgix LaxiForm / packaging - Box of 30 capsulesStatus - DrugShelf life: 2 years

Composition - Docusate sodium (Natrii docusas) 50 mg

Indication Constipation prevention and chronic constipation treatment; As an adjuvant treatment to patient with haemorrhoids and/or rectal fissures and for patients with contraindication for intensive straining when opening bowels; Preparation for diagnostic and surgical procedures.

Page 21: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

21 I PRIVATE LABEL

Line of excellent products for digestive system, which successfully solve common

and frequent disorders, like:

Product name - Ulgix DigestionForm / packaging - Box of 30 softgels Status - Dietary supplement

2. Indigestion, especially after rich meals - to be used ad hoc as an SOS agent

Composition Black radish dry extract 200 mgArtichoke dry extract 35 mgTurmeric dry extract 20 mgPeppermint dry extract 15 mg

Action Supports the process of digestion: especially of fats, carbohydrates and proteins. Helps with ensuring a healthy digestive tract and minimizes the effects of bad eating habits. Beneficial in case of slow digestive processes (so-called “lazy digestion”)

Product name - Ulgix Liver protectionForm / packaging - Box of 30 tabletsStatus - Dietary supplement

1. Liver troubles - Protection and stimulation = hepatoprotector, to be used prophylactically in long-term treatment

Composition L-Ornithine L-Aspartate 180 mgExtract from Schisandra Chinensis berries 40 mg

Action Supports proper functioning of the liver cells and protects it against harmful outer factors, e.g. stimulants, bad diet, pharmacological treatment

Product name - Ulgix Digestion drops Form / packaging - Bottle of 45 ml in a box Status - Dietary supplement

Composition (per 30 drops) Black radish dry extract 67 mgArtichoke dry extract 15.75 mgMint oil 6.75 mg

Action Stimulates the process of digestion by good impact on intestines, enhances production of digestive juices, supports liver activity, influences on a proper work of stomach; recommended after rich and fatty meals, in states of stomach fullness

Product name - Ulgix TotalForm / packaging - Box of 30 softgels Status - Dietary supplement

Composition Fennel fruit extract 120 mgSchisandra chinensis fruit extract 40 mgArtichoke dry extract 35 mgPeppermint dry extract 15 mg

Action Helpful in soothing the consequences of dietetic mistakes; stimulates the process of digestion; recommended after rich and fatty meals, for people who eat irregularly and in a hurry, in states of stomach fullness

Page 22: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

22 I PRIVATE LABEL

Line of unique cosmetics with DIOSMIN important for: blood vessels protection and improvement of skin condition on the legs

Product name- DIH Lipogel with diosmin and heparinForm / packaging - Tube of 100 g in a boxStatus - Cosmetic

Composition -Diosmin, heparin, menthol, aqua, propylene glycol, lecithin, carbomer, sodium hydroxide, parfum, sodium, methylparaben, disodium EDTA, limonene, citral

Action Recipe based on diosmin, heparin and menthol - recommended for skin with a tendency to so called „spider veins effect”

Product name- DIH Blood Vessels lipogelForm / packaging - Tube of 30 g in a boxStatus - Cosmetic

Composition - Diosmin, troxerutin, aqua, propylene glycol, lecithin, disodium EDTA, ammonium acryloyldimethyltaurate vp copolymer, parfum, limonene, hexyl cinnamal

Action Anti-oxidative formulation, protecting blood vessels, which removes red stains on skin and vessel extensions (“spider veins on legs”). Soothes the feeling of „heavy legs” and touch sensitiveness. Builds tension of vessels and makes them more flexible

Product name- DIH Spray lipogel Form / packaging - Bottle of 50 g with an applicator in a boxStatus - Cosmetic

Composition - Diosmin, aqua, propylene glycol, lecithin, potassium phosphate, carbomer, sodium hydroxide, sodium benzoate, potassium sorbate, sodium heparin hydroxycitronellal, hyfroxyisohexyl 3-cyclohexane carboxaldehyde, butylphenyl methylpropianol, citronellol, hexyl cinnamal, limonene, parfum

Action Removes blood vessel extensions (“spider veins on legs”), improves the look of the skin on legs. Soothes the feeling of „heavy legs” and reduces the swelling.

All 3 products are especially designed to release popular and frequent feeling of tiredness and „heavy legs” as well as to prevent legs from blood vessels disorders. Recommended for people exposed to work in standing or sitting position, travelling and living in hot weather conditions.

Page 23: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

23 I PRIVATE LABEL

Line of unique medicines with DIOSMIN important for: blood vessels protection and improvement of skin condition on the legs

The products are especially designed to release popular and frequent feeling of tiredness and „heavy legs” as well as to prevent legs from blood vessels disorders. Recommended for people exposed to work in standing or sitting position, travelling and living in hot weather conditions.

Product name- DIH MaxForm / packaging - Box of 30 tablets Status - OTC medicineShelf life: 18 months

Composition -Diosminmicronized 1000 mg

Action Doubled dosage of diosmin, especially helpful in night’s pain and leg muscle cramps, elimination of the feeling of „heavy legs”; an agent in treatment of varicose veins.

Product name- DIH Cyclo Form / packaging - Box of 30 capsulesStatus - Dietary supplementShelf life: 18 months

Composition - Micronised Diosmin 200 mgButcher’s broom extract – 100 mg including ruscogenins – 5 mg

Action Butcher’s broom root extract: stimulates proper function of blood vessels; increases the wall tension of blood vessels and stimulates the Venous blood and lymph flow to prevent blood and lymph stasis and oedema; gives the sensation of light legs; revitalises, refreshes and relieves tired and heavy legs. Diosmin is a valuable bioflavonoid. Due to micronisation, fine diosmin particles are better absorbed from the gastro-intestinal tract.

Product name- DIH CrampsForm / packaging - Box of 30 capsulesStatus - Dietary supplementShelf life: 18 months

Composition - Diosmin – 150 mg Troxerutin – 25 mg Magnesium – 30 mg Vitamin C – 6 mg

Action Diosmin and troxerutin are bioflavonoids.Due to micronisation, fine diosmin particles are better absorbed from the gastro-intestinal tract.Magnesium supports proper function of muscles, including the cardiac muscle. Vitamin C as an antioxidant helps protect cells against oxidative stress (free radicals). It also stimulates collagen production to ensure proper function and flexibility of blood vessels.

Product name- Diosmin HascoForm / packaging - Box of 30 tablets Status - Dietary supplementShelf life: 3 years

Composition -Diosmin micronized 300 mg

Action In states of fatigued and tired legs, feeling of “heavy legs”, for people working long hours in sitting or standing position.

Product name- DIH Form / packaging - Box of 30 tabletsStatus - OTC medicineShelf life: 3 years

Composition - Diosmin micronized 500 mg

Action • symptoms of Venous circulation failure • night’s pain and leg muscle cramps • feeling of „heavy legs” • symptomatic treatment of haemorrhoids

Page 24: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

24 I PRIVATE LABEL

Line of excellent products with well absorbable MAGNESIUM

Product name - BluMag CardioForm / packaging - Box of 30 softgelsStatus - Dietary supplement

1. Full magnesium DAILY dosage in 1 capsule + healthy stimulation of heart and cardiovascular system (OMEGA-3 acids)

Composition - Magnesium oxide (magnesium ions) 375 mgVitamin B6 1,4 mg; Omega 3 fatty acids: 253 mgEPA (eicosapentaenoic acid) 152 mgDHA (docosahexaenoic acid) 101 mg

Action Recommended for people with tendency to:- higher triglycerides level- improper cholesterol metabolism - weakness and tiredness - nervous tension and increased susceptibility to stress - increased physical effort Unsaturated Omega-3 fatty acids: EPA and DHA:- support heart activity and circulatory system - promote normalization of triglycerides level and arterial pressure - play an important role in proper development and functioning of the nervous system - support immunity

Product name - Magmil Bio specialForm / packaging - Box of 30 tabletsStatus - Dietary supplement

2. Innovative version of magnesium supplement for the sake of your health

Composition - Magnesium lactate 1000 mg (magnesium ions 100 mg)Vitamin B6 0.21 mg

Action The product supplements a diet with the componentssupporting physical and mental efficiency increase.Designed especially for people:- having difficulty with concentration;- with busy and exhausting lifestyle;- physically and sports active; - overtired, overworked and weakened;- exposed to stress.

Product name - Magmil Bio special kidsForm / packaging - PET bottle 150 mlStatus - Dietary supplement

3. Special elixir for kids, increasing natural physical and mental abilities, reducing nervous tension and irritability

Composition - Magnesium 0.443 g / 100 gVit. B6 0.013 g / 100 g

Action Product for children as a supplement of magnesium and vitamin B6 in daily diet, in states of:- increased nervous tension and excessive irritability - impaired ability to concentrate and remember- reduced physical and mental ability- increased susceptibility to stress

Page 25: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

25 I PRIVATE LABEL

Special care and supplementation for babies in comfortable and user-friendly packaging for the caring parent.

Product name - Juvit Baby D3

Form / packaging - Bottle 10 ml in a unitary boxStatus - Food for special dietary use

Composition - in 2 doses (2 pump presses): - vitamin D3 10 µg (400 i.u.)

Action 2 presses of pump give an amount containing 10 µg of vit. D3 (400 i.u), which complies with RDA for breast-fed infants. Recommended for kids from fourth month of living.

1. Drops covering daily recommended dosage of vit. D3 for babies

Product name - Juvit KForm / packaging - Bottle 10 mlin a unitary boxStatus - Food for special dietary use

Composition - in 1 dose (pump press): - vitamin K 12.5 µg (500 i.u.)

Action 2 presses of pump give an amount containing 25 µg of vit. K, which complies to RDA for breast-fed infants. The product is for a dietetic use in breast-fed infants. Recommended for kids of age within the range: two weeks up till the end of third month. One unitary packaging is enough for 1 month of use.

2. Drops covering daily recommended dosage of vit. K for babies

Product name - Juvit K+D3

Form / packaging - Bottle 10 ml in a unitary boxStatus - Food for special dietary use

Composition - in 2 doses(2 pump presses):- vitamin K 25 µg (1000 i.u.)- vitamin D3 10 μg (400 i.u)

Action 2 presses of pump give an amount containing 25 µg of vit. K and 10 µg (400 i.u.) - vit. D3, which complies to RDA for breast-fed infants. The product is for a dietetic use in breast-fed infants. Recommended for kids of age within the range: 8th day up till the end of third month. One unitary packaging is enough for 1 month of use.

3. Drops covering daily recommended dosage of vit. K and D3 for babies

Vitamins in drops for babies

Page 26: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

26 I PRIVATE LABEL

Product name – Medicerum SeboricalHair FOAMForm / packaging – Bottle with dispenser 125 mlStatus – Cosmetic

Active substances – ciclopirox olamine, piroctone olamine

Action Reduces seborrhea production of head skin and epidermal flaking, eliminates syndromes of dandruff and prevents from its regeneration, moisturizes and soothes epidermis, ease head skin cleaning from excess of flaked epidermis, soothes skin irritation, reduces redness and itching

Product name – Medicerum Atopical Body BALMForm / packaging – Bottle 200 gStatus – Cosmetic

Active substances – butyro-spermum parkii butter, hydroxyethyl urea, isopropylpalmitate, ceramide NP, ceramide AP, ceramide EOP

Action Strengthens natural lipid layer of epidermis, moisturizes and oils the skin, reduces dryness and roughness, improves skin condition and look, soothes irritation and redness; for dry, sensitive and atopic skin types

Product name – Medicerum Psorical CREAMForm / packaging – Tube 75 g Status – Cosmetic

Active substances – lactic acid, salicylic acid, allantoin, troxerutin, butyrospermum parkii butter

Action For special care of flaking epidermis with tendency to keratosis and irritation; reduces epidermal keratosis, removes thickened epidermis, soothes skin by moisturizing and oiling, soothes irritation and redness; for dry, sensitive and atopic skin types

Product name – Hascoderm lipogelForm / packaging – Tube 30 g in a box Status – Cosmetic

Composition – azelaicacid, propylene glycol, aqua,dimethicone, carbomer, sodiumhydroxide, lecithin, disodiumEDTA

Action Antibacterial, liposomal formula in form of gel for special careof greasy kind of skin, with sebborhea and tendencies to acne; brightensdiscolorations, balances natural skin colour

Innovative liposomal gel for acne skin on face, neck, chest and back

LINE of excellent dermal cosmeticswith focus on your head skin and body

Unique LINE of dermal cosmetics for sensitive skin types with tendency of flaking epidermis, dandruff, epidermal keratosis, irritation and redness

Page 27: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

27 I LICENSE - OUT

Page 28: 4 I COMPANY PROFILE Hasco-Lek, a pharmaceutical manufacturer, offers contractual services as well as finished products having more than 30 years of professional experience. COMPANY

28 I LICENSE - OUT

Headquarters and manufacturing site

Pharmaceutical Production Company Hasco-Lek S.A. ul. Żmigrodzka 242E, 51-131 Wrocław, Poland

tel.: +48 71 352 95 22; e-mail: [email protected]

You need support in:

International Distribution

Olena DenysyukInternational Trade Manager

tel. +48 71 327 19 [email protected]

Contract Manufacturing and Licenses

Maryana KatyńskaBusiness Development Manager

tel. +48 71 327 19 [email protected]

License in/out

Dominique MoreauProject Coordinator

tel. +48 71 327 19 [email protected]

Procurement

Anna RogowskaProcurement Directortel. +48 71 327 19 70

[email protected]