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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
PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS
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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
PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS
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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: [email protected]
Meet us on LinkedIn:
www.linkedin.com/company/polpharma-b2b