DOSSIER LIST

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ALIMENTARY TRACT & METABOLISM

1. Esomeprazole (sodium)

Powder for solution for infusion or injection 40 mg Nexium/

AstraZeneca Antiulcerant

2. Omeprazole Powder for solution for infusion 40 mg Losec/

AstraZeneca Antiulcerant

3. Orlistat OTC Capsules 60 mg Alli/GSK Obesity treatment

4. Orlistat Capsules 120 mg Xenical/Roche Obesity treatment

5. Pantoprazole (sodium sesquihydrate)

Powder for solution for injection 40 mg Pantozol/Altana Antiulcerant

6. Sitagliptin (phosphate) Film-coated tablets 25 mg | 50 mg | 100 mg Januvia/Merck Oral antidiabetic

ANTI-INFECTIVES FOR SYSTEMIC USE

7. Aciclovir Tablets 200 mg | 400 mg | 800 mg Zovirax/GSK Antiviral for systemic use

8. Clarithromycin Powder for solution for infusion 500 mg Klacid IV/Abbott Antibacterial for systemic use

9. Levofloxacin (hemihydrate) Film-coated tablets 250 mg | 500 mg Tavanic/

Sanofi-Aventis Antibacterial for systemic use

10. Levofloxacin (hemihydrate)** Solution for infusion 5 mg/ml (100 ml) Tavanic/

Sanofi-Aventis Antibacterial for systemic use

11. Linezolid Film-coated tablets 600 mg Zyvox/Pfizer Antibacterial for systemic use

12. Linezolid** Solution for infusion 2 mg/ml (300 ml) Zyvox/Pfizer Antibacterial for systemic use

13. Tenofovir disoproxil (fumarate) Film-coated tablets 245 mg Viread/Gilead

Science Antiviral for systemic use

14. Voriconazole Film-coated tablets 50 mg | 200 mg Vfend/Pfizer Antifungal for systemic use

CARDIOVASCULAR SYSTEM

15.Amlodipine (besilate) + Atorvastatin (calcium)

Film-coated tablets 5 mg + 10 mg | 10 mg + 10 mg | 10 mg + 20 mg | 5 mg + 20 mg

Norvasc (Amlodipine) + Sortis (Atorvastatin)/Pfizer

Calcium-channel blocker & cholesterol & triglyceride regulator combination

16. Amlodipine (maleate) + Valsartan Film-coated tablets 5 mg + 80 mg | 5 mg + 160 mg |

10 mg + 160 mgExforge/ Novartis

Calcium-channel blocker & angiotensin-II antagonist combination

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17. Bosentan* Film-coated tablets 62.5 mg | 125 mg Tracleer/ Actelion

Pulmonary arterial hypertension (PAH) treatment

18. Hydrochlorothiazide* Tablets 12.5 mg | 25 mg Esidrex/ Novartis Diuretic

19. Indapamide Prolonged-release tablets 1.5 mg Natrilix/Servier Diuretic

20. Metoprolol succinate Prolonged-release tablets 23.75 mg | 47.5 mg | 95 mg | 190 mg

Beloc-Zoc/ AstraZeneca Beta blocking agent

21. Metoprolol tartrate Solution for injection 1 mg/ml Betaloc/ AstraZeneca Beta blocking agent

22. Noradrenaline (tartrate)** Solution for injection 1 mg/ml (1 ml, 4 ml) --- Vasopressor and cardiac arrest

management

23. Ramipril + Amlodipine (besilate) Capsules 5 mg + 5 mg | 5 mg + 10 mg |

10 mg + 5 mg | 10 mg + 10 mg

Tritace (Ramipril)/Sanofi Aventis + Norvasc (Amlodipine)/Pfizer

Calcium-channel blocker & ACE inhibitor combination

24. Rosuvastatin (calcium)* Film-coated tablets 5 mg | 10 mg | 20 mg | 40 mg Crestor/

AstraZenecaCholesterol & triglyceride regulator

25. Sildenafil (citrate)* Film-coated tablets 20 mg Revatio/Pfizer Pulmonary arterial hypertension (PAH) treatment

DERMATOLOGICALS

26. Dimetindene OTC Gel 1 mg/g (20 g, 30 g, 50 g) Fenistil/ Novartis Topical antipruritic

GENITO-URINARY SYSTEM & SEX HORMONES

27. Tadalafil* Film-coated tablets 2.5 mg | 5 mg | 10 mg | 20 mg Cialis/Eli Lilly Erectile dysfunction treatment

28. Vardenafil (hydrochloride)* Film-coated tablets 5 mg | 10 mg | 20 mg Levitra/Bayer Erectile dysfunction treatment

MUSCULO-SKELETAL SYSTEM

29. Alendronic acid* Tablets 70 mg Fosamax/MSD Bone calcium regulator

30. Ibuprofen OTC Oral suspension 100 mg/5 ml (orange, raspberry, strawberry flavours) --- Non-steroid antiinflamatory

and antirheumatic

31. Ibuprofen OTC Oral suspension 200 mg/5 ml (raspberry, strawberry flavours) --- Non-steroid antiinflamatory

and antirheumatic

AVAILABLE DOSSIERS

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NERVOUS SYSTEM

32. Atomoxetine (hydrochloride) Capsules 5 mg | 10 mg | 18 mg | 25 mg |

40 mg | 60 mg | 80 mg | 100 mg Strattera/Eli Lilly ADHD treatment

33. Citalopram (hydrobromide) Film-coated tablets 10 mg | 20 mg | 30 mg | 40 mg Seropram/

Lundbeck Antidepressant

34. Haloperidol Solution for injection 5 mg/ml (1 ml) Haldol/Janssen--Cilag Antipsychotic

35. Memantine hydrochloride Film-coated tablets 10 mg | 20 mg Ebixa/Lundbeck Alzheimer disease treatment

36. Propofol Emulsion for injection or infusion 10 mg/ml (20 ml) Diprivan/

AstraZeneca Anaesthetic

37. Quetiapine (fumarate) Film-coated tablets 25 mg | 100 mg | 150 mg | 200 mg | 300 mg

Seroquel/ AstraZeneca Antipsychotic

OPHTHALMOLOGICALS

38. Bimatoprost Eye drops solution without preservatives 0.3 mg/ml Lumigan/

Allergan Miotic & antiglaucoma

39. Bimatoprost + Timolol (maleate) NEW!

Eye drops solution without preservatives (0.3 mg + 5.0 mg)/ml Ganfort/

Allergan Miotic & antiglaucoma

40. Brimonidine tartrate** Eye drops solution without preservatives 2 mg/ml Alphagan/

Allergan Miotic & antiglaucoma

41. Dorzolamide (hydrochloride)

Eye drops solution without preservatives 20 mg/ml Trusopt/MSD Miotic & antiglaucoma

42.Dorzolamide (hydrochloride) + Timolol (maleate)

Eye drops solution without preservatives (20 mg + 5 mg)/ml Cosopt/MSD Miotic & antiglaucoma

RESPIRATORY SYSTEM

43. Hedera helix dry extract OTC Syrup 27.78 mg/5 ml (100 ml) --- Expectorant

44.Xylometazoline (hydrochloride) + Dexpanthenol OTC

Nasal spray solution (1 mg + 50 mg)/ml Nasic/Cassella--med

Nasal descongestant & mucosal regenerator

* Polpharma Group API** Dossier available on client’s request Herbal medicinal productFor more information and up-dates regarding available dossiers and dossiers in development, please contact your assigned Sales Manager or our Commercial Department. Note: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be restricted to certain markets or countries.

PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS

October 2017

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WE OFFER

High level of customer service

Excellent products with CTD dossiers meeting EU requirements

Regulatory knowledge and expertise

Full support in developing registration strategies to meet the needs of our customers

Execution and support in registration procedures upon customer’s request

QA service and pharmacovigilance service (PSUR)

Intellectual property expertise

Highly skilled and professional team of Project Managers

Partnership in a win-win strategy

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CONTACT

POLPHARMA GROUPPHARMACEUTICAL WORKSPelplińska 1983-200 Starogard GdańskiPolandPhone: +48 58 563 16 00Fax: +48 58 562 23 53www.polpharma.pl

POLPHARMA B2BSTRATEGIC PARTNER, FARMAPROJECTSCarrer Provença 392, 6ª Planta 08025 Barcelona (Spain)Phone: +34 93 508 05 00Fax: +34 93 508 05 01e-mail: salesb2b@polpharma.comwww.polpharmab2b.com

Meet us on LinkedIn:

www.linkedin.com/company/polpharma-b2b