Porton Pharma Solutions is an API manufacturer based in China. It holds 25 active US drug master files and 2 valid CEPs across a filed portfolio of 19 molecules. Its filings concentrate with EMA, DMP (NO) and URPL (PL). Its GMP standing is certified by MHRA (UK), US FDA and WHO (PQ), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 29 March 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Chongqing, China | Not on file |
| Changshou, China | Not on file |
| Chongqing, China | Not on file |
| Changshou, China | Not on file |
| China, China | 3006625990 |
| SALISBURY, United Kingdom | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Nicotine | EDQM, US FDA | 3 |
| Abemaciclib | US FDA | 1 |
| Alectinib | US FDA | 1 |
| Baloxavir Marboxil | US FDA | 1 |
| Dapagliflozin | US FDA | 1 |
| Darunavir | US FDA | 1 |
| Dexrazoxane | US FDA | 1 |
| Hydroxychloroquine | EDQM | 1 |
| Isavuconazonium | US FDA | 1 |
| Mefloquine | US FDA | 1 |
| Niraparib | US FDA | 1 |
| Phloroglucinol | US FDA | 1 |
| Relugolix | US FDA | 1 |
| Rimegepant | US FDA | 1 |
| Salmeterol | US FDA | 1 |
| Tiopronin | US FDA | 1 |
| Venetoclax | US FDA | 1 |
| Vibegron | US FDA | 1 |
| Vonoprazan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 6 | 1 |
| DMP (NO) | 2 | None |
| URPL (PL) | 1 | None |
| ANSM (FR) | 1 | None |
| MPA (SE) | 1 | None |
| FAMHP (BE) | 1 | None |
| MHRA (UK) | None | 4 |
| US FDA | None | 1 |
| WHO (PQ) | None | 1 |
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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