DOSSIER FDFLIST
Product name Pharmaceutical form Strength Reference Therapeutic class ALIMENTARY TRACT & METABOLISM 1. Esomeprazole sodium or injection 40 mg Nexium / AstraZeneca Antiulcerant 2. Omeprazole sodium 40 mg Losec / AstraZeneca Antiulcerant 3. Orlistat Capsules 60 mg 120 mg Alli / GSK Xenical / Roche Obesity treatment 4. Pantoprazole sodium sesquihydrate for injection 40 mg Pantozol / Altana Antiulcerant 5. Sitagliptin phosphate 25 mg 50 mg 100 mg Januvia / Merck Oral antidiabetic ANTI-INFECTIVES FOR SYSTEMIC USE 6. Aciclovir Tablets 200 mg 400 mg 800 mg Zovirax / Glaxo Antiviral for systemic use 7. Clarithromycin 500 mg Klacid IV / Abbot Antibacterial for systemic use 8. Levofloxacin hemihydrate 250 mg 500 mg Tavanic / Aventis Antibacterial for systemic use 9. Levofloxacin hemihydrate Solution 5 mg/ml (50 ml, 100 ml) Tavanic / Aventis Antibacterial for systemic use 10. Linezolid 600 mg Zyvox / Pfizer Antibacterial for systemic use 11. Linezolid Solution 2 mg/ml (300 ml) Zyvox / Pfizer Antibacterial for systemic use 12. Tenofovir 245 mg Viread / Gilead Science Antiviral for systemic use 13. Voriconazole 50 mg 200 mg Vfend / Pfizer Antifungal for systemic use 14. Voriconazole 200 mg Vfend / Pfizer Antifungal for systemic use ANTINEOPLASTIC & IMMUNOMODULATING AGENTS 15. Imatinib 100 mg 200 mg 400 mg Glivec / Novartis Antineoplastic
AVAILABLE DOSSIERS Product name Pharmaceutical form Strength Reference Therapeutic class CARDIOVASCULAR SYSTEM 16. Amlodipine besilate + Atorvastatin calcium 5mg + 10mg 10mg + 10mg 10mg + 20mg 5mg + 20mg Caduet / Pfizer Calcium-channel blocker and cholesterol & triglyceride regulator combination 17. Amlodipine besilate + Ramipril Capsules 5mg + 5mg 5mg + 10mg 10mg + 5mg 10mg + 10mg --- Calcium-channel blocker & ACE inhibitor combination 18. Amlodipine maleate + Valsartan 5 mg + 80 mg 5 mg + 160 mg 10 mg + 160 mg Exforge / Novartis Calcium-channel blocker & angiotensin-ii antagonist combination 19. Bosentan * 62.5 mg 125 mg Tracleer / Actelion Pulmonary arterial hypertension (PAH) treatment 20. Hydrochlorothiazide * Tablets 12.5 mg 25 mg --- Diuretic 21. Indapamide Prolonged-release tablets 1.5 mg Natrilix / Servier Diuretic 22. Metoprolol succinate Prolonged-release tablets 23.75 mg 47.5 mg 95 mg 190 mg Beloc-Zoc / AstraZeneca Beta blocking agent 23. Metoprolol tartrate Solution for injection 1 mg/ml Betaloc / AstraZeneca Beta blocking agent 24. Noradrenaline bitartrate Solution for injection 1 mg/ml (1 ml, 4 ml) Noradrenaline / Hospira Vasopressor and cardiac arrest management 25. Rosuvastatin calcium * 5 mg 10 mg 20 mg 40 mg Crestor / AstraZeneca Cholesterol & triglyceride regulator 26. Sildenafil citrate * 20 mg Revatio / Pfizer Pulmonary arterial hypertension (PAH) treatment 27. Simvastatin 10 mg 20 mg 40 mg 80 mg Zocor / MSD Cholesterol & triglyceride regulator DERMATOLOGICALS 28. Dimetindene Gel 1 mg/g Fenistil / Novartis Topical antipruritic GENITO-URINARY SYSTEM & SEX HORMONES 29. Tadalafil * 2.5 mg 5 mg 10 mg 20 mg Cialis / Eli Lilly Erectile dysfunction treatment 30. Vardenafil hydrochloride * 5 mg 10 mg 20 mg Levitra / Bayer Erectile dysfunction treatment MUSCULO-SKELETAL SYSTEM 31. Alendronic acid * Tablets 70 mg Fosamax / Merck Bone calcium regulator
February 2017 Product name Pharmaceutical form Strength Reference Therapeutic class NERVOUS SYSTEM 32. Atomoxetine Capsules 5mg 10mg 18mg 25mg 40mg 60mg 80mg 100mg Strattera / Eli Lilly ADHD treatment 33. Citalopram hydrobromide 10 mg 20 mg 30 mg 40 mg Seropram / Lundbeck Antidepressant 34. Haloperidol Solution for injection 5 mg/ml (1 ml) Haldol / Janssen Antipsychotic 35. Memantine hydrochloride 10 mg 20 mg Ebixa / Lundbeck Alzheimer disease treatment 36. Pregabalin Capsules 25 mg 50 mg 75 mg 100 mg 150 mg 200 mg 225 mg 300 mg Lyrica / Pfizer Antiepileptic 37. Propofol Emulsion for injection or infusion 10 mg/ml (20 ml) Diprivan / Astra Zeneca Anaesthetic 38. Quetiapine fumarate 25 mg 100 mg 150 mg 200 mg 300 mg Seroquel / AstraZeneca Antipsychotic OPHTHALMOLOGICALS 39. Bimatoprost 40. Brimonidine NEW! 41. Dorzolamide 42. Dorzolamide + Timolol 0.3 mg/ml Lumigan / Allergan Miotic & antiglaucoma 2 mg/ml Alphagan / Allergan Miotic & antiglaucoma 20 mg/ml Trusopt / MSD Miotic & antiglaucoma (20 mg + 5 mg)/ml Cosopt / MSD Miotic & antiglaucoma RESPIRATORY SYSTEM 43. Montelukast sodium 10 mg Singulair / Merck Asthma treatment 44. Montelukast sodium NEW! Oral granules (sachets) 4 mg Singulair / Merck Asthma treatment 45. Xylometazoline hydrochloride + Dexpanthenol NEW! Nasal spray solution (1 mg + 50 mg)/ml Nasic / Cassella-med Nasal descongestant & mucosal regenerator * Polpharma Group API For 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.
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 CONTACT POLPHARMA GROUP Pharmaceutical Works Pelplińska 19 83-200 Starogard Gdański Poland Phone: +48 58 563 16 00 Fax: +48 58 562 23 53 www.polpharma.pl POLPHARMA B2B STRATEGIC PARTNER, FARMAPROJECTS Santa Eulàlia 240-242 08902 L Hospitalet de Llobregat Barcelona (Spain) Phone: +34 93 508 05 00 Fax. +34 93 508 05 01 e-mail: salesb2b@polpharma.com www.polpharmab2b.com