Chunghwa Chemical Synthesis & Biotech is an API manufacturer based in Taiwan. It holds 29 active US drug master files across a filed portfolio of 22 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 April 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Taiwan, Taiwan | 3002806677 |
| New Taipei City, Taiwan | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Everolimus | SFDA (Saudi Arabia), US FDA | 4 |
| Caspofungin | SFDA (Saudi Arabia), US FDA | 3 |
| Mycophenolic Acid | US FDA | 3 |
| Sirolimus | SFDA (Saudi Arabia), US FDA | 3 |
| Tacrolimus | US FDA | 3 |
| Mycophenolate Mofetil | SFDA (Saudi Arabia), US FDA | 2 |
| Baricitinib | US FDA | 1 |
| Brivaracetam | US FDA | 1 |
| Dexbrompheniramine | US FDA | 1 |
| Difelikefalin | US FDA | 1 |
| Eltrombopag | US FDA | 1 |
| Eslicarbazepine Acetate | US FDA | 1 |
| Icosapent Ethyl | US FDA | 1 |
| Midostaurin | US FDA | 1 |
| Ozanimod | US FDA | 1 |
| Palbociclib | US FDA | 1 |
| Plecanatide | US FDA | 1 |
| Ribociclib | US FDA | 1 |
| Selumetinib | US FDA | 1 |
| Setmelanotide | US FDA | 1 |
| Tofacitinib | US FDA | 1 |
| Trilaciclib | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 2 |
| US FDA | 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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