DOSSIER LIST. tlo_seledyn.pdf :38:01 CMY K CM MY CY
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1 tlo_seledyn.pdf :38:01 C M Y CM MY CY CMY K DOSSIER LIST
2 AVAILABLE DOSSIERS THERAPEUTIC CLASS / MAIN INDICATION LACTOSE FREE ZONE IV CPP FEASIBILITY ALIMENTARY TRACT & METABOLISM 1. Esomeprazole (sodium) Powder for solution for infusion or injection 40 mg Nexium / Peptic ulcer and gastro-oesophageal reflux disease 2. Omeprazole Powder for solution for infusion 40 mg Losec / Peptic ulcer and gastro-oesophageal reflux disease 3. Orlistat OTC Hard capsules 60 mg Alli / GSK Anti-obesity 4. Orlistat Hard capsules 1 Xenical / Roche Anti-obesity 5. Pantoprazole (sodium sesquihydrate) Powder for solution for injection 40 mg Pantozol / Altana Peptic ulcer and gastro-oesophageal reflux disease 6. Sitagliptin (hydrochloride) 25 mg 50 mg 100 mg Januvia / Merck Blood glucose lowering drug (DPP4-i) 7. Sitagliptin (hydrochloride) / Metformin 50/850 mg 50/1000 mg Janumet / Merck Blood glucose lowering drugs ANTI-INFECTIVES FOR SYSTEMIC USE 8. Aciclovir Tablets 200 mg 400 mg 800 mg Zovirax / GSK Antiviral 9. Clarithromycin Powder for solution for infusion 500 mg Klacid IV / Abbott Antibacterial 10. Linezolid 600 mg Zyvox / Pfizer Antibacterial 11. Tenofovir disoproxil (fumarate) 245 mg Viread / Gilead Science Antiviral 12. Voriconazole 50 mg 200 mg Vfend / Pfizer Antimycotic BLOOD & BLOOD ING ORGANS 13. Apixaban NEW! 2.5 mg 5 mg Eliquis / Bristol- -Myers Squibb Antithrombotic 14. Rivaroxaban* CA 2.5 mg 15 mg Xarelto / Bayer Antithrombotic 15. Ticagrelor* 60 mg 90 mg Brilique / Antithrombotic
3 AVAILABLE DOSSIERS THERAPEUTIC CLASS / MAIN INDICATION LACTOSE FREE ZONE IV CPP FEASIBILITY CARDIOVASCULAR SYSTEM 16. Amlodipine (besilate) / Atorvastatin (calcium) 5/ 10/ 5/ 10/ Norvasc (Amlodipine) + Sortis (Atorvastatin) / Pfizer Calcium channel blocker & lipid modifying 17. Amlodipine (maleate) / Valsartan 5/80 mg 5/160 mg 10/160 mg Exforge / Novartis Calcium channel blocker & angiotensin-ii antagonist 18. Amlodipine (maleate) / Valsartan / Hydrochlorothiazide* 5/160/12.5 mg 10/160/12.5 mg Exforge 10/320/25 mg HCT / 10/160/25 mg Novartis 5/160/25 mg Calcium channel blocker & angiotensin-ii antagonist & diuretic 19. Bosentan* 62.5 mg 125 mg Tracleer / Actelion Antihypertensive for pulmonary arterial hypertension (PAH) 20. Hydrochlorothiazide* Tablets 12.5 mg 25 mg Esidrex / Novartis Diuretic 21. Indapamide Prolonged- -release 1.5 mg Natrilix / Servier Diuretic 22. Metoprolol tartrate Solution for injection 1 mg/ml (5ml) Betaloc / Beta blocking IVa: on-going 23. Ramipril / Amlodipine (besilate) Hard capsules 5/5 mg 5/ 10/5 mg 10/ Tritace (Ramipril) / Sanofi & Norvasc (Amlodipine) / Pfizer ACE inhibitor & calcium channel blocker 24. Rosuvastatin (calcium)* 5 mg 40 mg Crestor / Lipid modifying 25. Sildenafil (citrate)* Revatio / Pfizer Antihypertensive for pulmonary arterial hypertension (PAH) 26. Telmisartan / Amlodipine NEW! Tablets 40/ 40/5 mg 80/ 80/5 mg Twinsta / Boehringer Ingelheim Angiotensin-II antagonist & calcium channel blocker DERMATOLOGICALS 27. Dimetindene OTC Gel 1 mg/g (20g, 30g, 50g) Fenistil / Novartis Topical antipruritic
4 _SELEDYN.pdf :38:01 AVAILABLE DOSSIERS THERAPEUTIC CLASS / MAIN INDICATION LACTOSE FREE ZONE IV CPP FEASIBILITY GENITO-URINARY SYSTEM & SEX HORMONES 28. Tadalafil* 2.5 mg 5 mg Cialis / Eli Lilly Erectile dysfunction 29. Vardenafil (hydrochloride)* 5 mg Levitra / Bayer Erectile dysfunction MUSCULO-SKELETAL SYSTEM 30. Ibuprofen OTC Oral suspension 100 mg/5 ml (Flavours: orange, raspberry, strawberry) -- Anti-inflammatory and antirheumatic (1) 31. Ibuprofen OTC Oral suspension 200 mg/5 ml (Flavours: raspberry, strawberry) -- Anti-inflammatory and antirheumatic NERVOUS SYSTEM 32. Atomoxetine (hydrochloride) Hard capsules 5 mg 18 mg 25 mg 40 mg 60 mg 80 mg 100 mg Strattera / Eli Lilly Attention-Deficit/ Hyperactivity Disorder (ADHD) 33. Dimethyl fumarate NEW! Gastro- -resistant hard capsules mg Tecfidera / Biogen Idec Relapsing forms of Multiple Sclerosis (MS) 34. Haloperidol Solution for injection 5 mg/ml (1 ml) Haldol / Janssen Antipsychotic 35. Memantine hydrochloride Ebixa / Lundbeck Anti-dementia 36. Metamizole sodium NEW! 500 mg Novalgin / Sanofi Aventis Analgesic and antipyretic 37. Propofol (2) for injection Emulsion or infusion /ml (20 ml) Diprivan / General anesthetic 38. Quetiapine (fumarate) 25 mg 100 mg 150 mg 200 mg 300 mg Seroquel / Antipsychotic
5 AVAILABLE DOSSIERS THERAPEUTIC CLASS / MAIN INDICATION LACTOSE FREE ZONE IV CPP FEASIBILITY RESPIRATORY SYSTEM 39. Hedera helix dry extract OTC Syrup mg / 5 ml (100 ml) -- Expectorant 40. Xylometazoline (hydrochloride) / Dexpanthenol (3) OTC Nasal spray solution 1 mg/ml + 50 mg/ml (10 ml) Nasic / Cassella-med Nasal descongestant & cicatrizant * Polpharma Group API CA Dossier also available for Canadian market (1) Stability zone IVb on-going only for strawberry flavour (2) Dossier update not earlier than Q (3) Dossier availability subject to some restrictions = Not available, can be extrapolated from IVb = Not available, can be extrapolated from IVa = Not available and cannot be extrapolated from IVa = Not Available Data Herbal medicinal product Dossier ready to file
6 DOSSIERS UNDER DEVELOPMENT THERAPEUTIC CLASS / MAIN INDICATION DOSSIER AVAILABILITY ALIMENTARY TRACT & METABOLISM 1. Dapagliflozin* NEW! 5 mg Forxiga / Astra Zeneca Blood glucose lowering drug (SGLT2-i) Early stage 2. Linagliptin* 5 mg Trajenta / Boehringer Ingelheim Blood glucose lowering drug (DPP4-i) 2019 Q1 3. Linagliptin* / Metformin 2.5/500 mg 2.5/850 mg 2.5/1000 mg Jentadueto / Boehringer Ingelheim Blood glucose lowering drugs 2020 Q1 BLOOD & BLOOD ING ORGANS 4. Dabigatran etexilate (mesylate)* Capsules 75 mg mg Pradaxa / Boehringer Ingelheim Antithrombotic 2020 Q2 CARDIOVASCULAR SYSTEM 5. Enalapril Tablets 5 mg Xanef (Vasotec, Renitec) / MSD ACE inhibitor To be confirmed 6. Enalapril / Hydrochlorothiazide* Tablets 10/25 mg 20/12.5 mg Innozide (Co-Renitec) / MSD ACE inhibitor & diuretic To be confirmed 7. Hydrochlorothiazide* Tablets 50 mg Esidrex / Novartis Diuretic 2019 Q2 DERMATOLOGICALS 8. Adapalene / Benzoyl peroxide Gel 0.1% + 2.5% Epiduo / Galderma Anti-acne for topical use 2020 Q1 9. Equisetum arvense / Methylsulfonylmethane / Hydroxypropylchitosan Water-soluble nail lacquer not applicable Sililevo / Taurus Pharma Medical device Nail strengthener 2020 Q1 NERVOUS SYSTEM 10. Ibuprofen / Paracetamol 200/500 mg Nurofen Ultima / Reckitt Benckiser Analgesic and antipyretic 2019 Q4 ONCOLOGY 11. Lenalidomide NEW! Capsules 2.5 mg I 5 mg I 7.5 mg I 15 mg I 25 mg Revlimid / Celgene Immunosuppressant 2020 Q1 * Polpharma Group API For more information and updates regarding available dossiers and dossiers under 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. Last update: February 2019
7 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
8 CONTACT POLPHARMA GROUP WORKS Pelplińska Starogard Gdański Poland Phone: Fax: POLPHARMA B2B STRATEGIC PARTNER, FARMAPROJECTS Carrer Provença 392, 6ª Planta Barcelona (Spain) Phone: Fax: Meet us on LinkedIn:
DOSSIER LIST. tlo_seledyn.pdf :38:01 CMY K CM MY CY
tlo_seledyn.pdf 1 22.08.2017 14:38:01 C M Y CM MY CY CMY K DOSSIER LIST tlo_seledyn.pdf 1 22.08.2017 14:38:01 PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS ALIMENTARY TRACT & METABOLISM
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