Formosa Laboratories is an API manufacturer based in Taiwan. It holds 51 active US drug master files and 8 valid CEPs. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 July 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Taoyuan, Taiwan | Not on file |
| Taiwan, Taiwan | 3003420376 |
| Molecule | Regulators | Docs |
|---|---|---|
| Calcipotriol | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Calcitriol | EDQM, US FDA | 3 |
| Sevelamer | US FDA | 3 |
| Sevelamer Carbonate | SFDA (Saudi Arabia) | 3 |
| Temozolomide | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Calcifediol | EDQM, US FDA | 2 |
| Capsaicin | SFDA (Saudi Arabia), US FDA | 2 |
| Colesevelam | US FDA | 2 |
| Leflunomide | EDQM, US FDA | 2 |
| Linezolid | SFDA (Saudi Arabia), US FDA | 2 |
| Montelukast | EDQM, US FDA | 2 |
| Mycophenolic Acid | US FDA | 2 |
| Nintedanib | US FDA | 2 |
| Paricalcitol | SFDA (Saudi Arabia), US FDA | 2 |
| Teriflunomide | SFDA (Saudi Arabia), US FDA | 2 |
| Abemaciclib | US FDA | 1 |
| Anastrozole | US FDA | 1 |
| Apraclonidine | US FDA | 1 |
| Balsalazide | US FDA | 1 |
| Benzonatate | US FDA | 1 |
| Capivasertib | US FDA | 1 |
| Colestipol | US FDA | 1 |
| Dinalbuphine Sebacate | US FDA | 1 |
| Doxercalciferol | US FDA | 1 |
| Elagolix | US FDA | 1 |
| Ergocalciferol | US FDA | 1 |
| Eribulin | US FDA | 1 |
| Ferric Carboxymaltose | US FDA | 1 |
| Fondaparinux | US FDA | 1 |
| Gadobutrol | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 2 | None |
| EMA | None | 2 |
| US FDA | None | 1 |
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