Zhejiang Tianyu Pharmaceutical is an API manufacturer based in China. It holds 12 active US drug master files and 17 valid CEPs across a filed portfolio of 19 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 29 November 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Taizhou City, China | Not on file |
| Taizhou, China | Not on file |
| China, China | 3010972581 |
| Molecule | Regulators | Docs |
|---|---|---|
| Losartan | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Valsartan | EDQM, US FDA | 4 |
| Irbesartan | EDQM, SFDA (Saudi Arabia) | 3 |
| Montelukast | EDQM, US FDA | 2 |
| Olmesartan Medoxomil | EDQM, SFDA (Saudi Arabia) | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Sacubitril | US FDA | 2 |
| Telmisartan | EDQM | 2 |
| Brivaracetam | EDQM | 1 |
| Cabozantinib | US FDA | 1 |
| Candesartan Cilexetil | EDQM | 1 |
| Dabigatran Etexilate Mesilate | EDQM | 1 |
| Edoxaban | US FDA | 1 |
| Ezetimibe | US FDA | 1 |
| Losartan Potassium | EDQM | 1 |
| Nicorandil | EDQM | 1 |
| Olmesartan | US FDA | 1 |
| Sitagliptin | EDQM | 1 |
| Ticagrelor | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
| EMA | None | 1 |
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