Zaklady Farmaceutyczne Polpharma is an API and finished-dose manufacturer based in Poland. It holds 41 active US drug master files. Its filings concentrate with EMA, MPA (SE) and AEMPS (ES). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 25 May 2018 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Poland, Poland | 3002807920 |
| Sieradz, Poland | Not on file |
| Blonie, Poland | Not on file |
| STAROGARD GDANSKI, Poland | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Aripiprazole | US FDA | 2 |
| Carvedilol | US FDA | 2 |
| Dapagliflozin | US FDA | 2 |
| Hydrochlorothiazide | SFDA (Saudi Arabia), US FDA | 2 |
| Ticagrelor | SFDA (Saudi Arabia), US FDA | 2 |
| Abemaciclib | US FDA | 1 |
| Acetazolamide | US FDA | 1 |
| Alendronic Acid | US FDA | 1 |
| Apixaban | US FDA | 1 |
| Apremilast | US FDA | 1 |
| Aripiprazole Lauroxil | US FDA | 1 |
| Avanafil | US FDA | 1 |
| Baclofen | US FDA | 1 |
| Baricitinib | US FDA | 1 |
| Brexpiprazole | US FDA | 1 |
| Carbamazepine | US FDA | 1 |
| Empagliflozin | US FDA | 1 |
| Enzalutamide | US FDA | 1 |
| Etodolac | US FDA | 1 |
| Ibandronate | US FDA | 1 |
| Isavuconazonium | US FDA | 1 |
| Lamotrigine | US FDA | 1 |
| Linagliptin | US FDA | 1 |
| Oxcarbazepine | US FDA | 1 |
| Palbociclib | US FDA | 1 |
| Pentoxifylline | US FDA | 1 |
| Pimavanserin | US FDA | 1 |
| Rivaroxaban | US FDA | 1 |
| Sacubitril/Valsartan | US FDA | 1 |
| Safinamide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 737 | 5 |
| MPA (SE) | 24 | None |
| AEMPS (ES) | 9 | None |
| ARCSA (EC) | 4 | None |
| FAMHP (BE) | 4 | None |
| ANSM (FR) | 2 | None |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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