Viwit Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files and 5 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 July 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Tengzhou, China | Not on file |
| China, China | 3008307561 |
| China, China | 3009868618 |
| China, China | 3006068789 |
| Molecule | Regulators | Docs |
|---|---|---|
| Gadobutrol | EDQM, US FDA | 3 |
| Aprepitant | EDQM, US FDA | 2 |
| Luliconazole | SFDA (Saudi Arabia), US FDA | 2 |
| Mirabegron | EDQM, US FDA | 2 |
| Varenicline | SFDA (Saudi Arabia), US FDA | 2 |
| Efinaconazole | US FDA | 1 |
| Fosaprepitant | US FDA | 1 |
| Gadoteric Acid | US FDA | 1 |
| Lidocaine | EDQM | 1 |
| Lifitegrast | US FDA | 1 |
| Perfluorohexyloctane | US FDA | 1 |
| Vildagliptin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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