Inner Mongolia Changsheng Pharmaceutical is an API manufacturer based in China. It holds 7 active US drug master files and 5 valid CEPs across a filed portfolio of 6 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 November 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hohhot, China | Not on file |
| Tuoketuo, China | Not on file |
| China, China | 3006272230 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ampicillin | EDQM, US FDA | 5 |
| Amoxicillin | EDQM, US FDA | 2 |
| Benzylpenicillin | EDQM, US FDA | 2 |
| Amoxicillin Trihydrate | EDQM | 1 |
| Piperacillin | US FDA | 1 |
| Sulbactam | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 1 |
| US FDA | None | 1 |
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