Suzhou Lixin Pharmaceutical is an API manufacturer based in China. It holds 4 active US drug master files and 8 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 August 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Suzhou, China | Not on file |
| China, China | 3008251350 |
| Molecule | Regulators | Docs |
|---|---|---|
| Indapamide | EDQM, SFDA (Saudi Arabia) | 2 |
| Bumetanide | EDQM | 1 |
| Dacarbazine | EDQM | 1 |
| Hydrochlorothiazide | EDQM | 1 |
| Idebenone | US FDA | 1 |
| Nilotinib | US FDA | 1 |
| Pemetrexed | US FDA | 1 |
| Pemetrexed Disodium | EDQM | 1 |
| Pemetrexed Disodium 2.5-Hydrate | EDQM | 1 |
| Semaglutide | US FDA | 1 |
| Temozolomide | EDQM | 1 |
| Ticagrelor | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 1 |
| US FDA | None | 1 |
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