Changzhou Pharmaceutical Factory is an API manufacturer based in China. It holds 174 active US drug master files. Its filings concentrate with US FDA and MINSA (CR). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 January 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Changzhou, China | Not on file |
| China, China | 3002806661 |
| Molecule | Regulators | Docs |
|---|---|---|
| Doxycycline | US FDA | 12 |
| Ticagrelor | US FDA | 12 |
| Sacubitril | US FDA | 9 |
| Ezetimibe | US FDA | 6 |
| Pregabalin | US FDA | 6 |
| Rosuvastatin | US FDA | 6 |
| Ruxolitinib | US FDA | 6 |
| Upadacitinib | US FDA | 6 |
| Valsartan | US FDA | 6 |
| Hydrochlorothiazide | SFDA (Saudi Arabia), US FDA | 4 |
| Abemaciclib | US FDA | 3 |
| Abrocitinib | US FDA | 3 |
| Agomelatine | US FDA | 3 |
| Apixaban | US FDA | 3 |
| Apremilast | US FDA | 3 |
| Atorvastatin | US FDA | 3 |
| Baloxavir Marboxil | US FDA | 3 |
| Bictegravir | US FDA | 3 |
| Cabozantinib | US FDA | 3 |
| Canagliflozin | US FDA | 3 |
| Captopril | US FDA | 3 |
| Crisaborole | US FDA | 3 |
| Dabigatran Etexilate | US FDA | 3 |
| Darolutamide | US FDA | 3 |
| Deucravacitinib | US FDA | 3 |
| Elagolix | US FDA | 3 |
| Eltrombopag | US FDA | 3 |
| Finerenone | US FDA | 3 |
| Lenalidomide | US FDA | 3 |
| Niraparib | US FDA | 3 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 6 | 1 |
| MINSA (CR) | 6 | None |
| EMA | 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.
Choose your molecules and target markets. Changzhou Pharmaceutical Factory comes back tiered against every other supplier able to file there.
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