Jiangsu Hengrui Pharmaceuticals is an API manufacturer based in China. It holds 18 active US drug master files and 6 valid CEPs across a filed portfolio of 19 molecules. Its filings concentrate with US FDA, ARCSA (EC) and MINSA (CR). Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 4 April 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Lianyugang, United Arab Emirates | Not on file |
| JIANGSU, China | Not on file |
| Lianyungang, China | Not on file |
| China, China | 3011603969 |
| China, China | 3006689263 |
| Molecule | Regulators | Docs |
|---|---|---|
| Oxaliplatin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Etoposide | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Dexmedetomidine | SFDA (Saudi Arabia), US FDA | 2 |
| Letrozole | EDQM | 2 |
| Sevoflurane | EDQM, US FDA | 2 |
| Bupivacaine | US FDA | 1 |
| Carmustine | US FDA | 1 |
| Caspofungin | US FDA | 1 |
| Cyclophosphamide | US FDA | 1 |
| Desflurane | US FDA | 1 |
| Docetaxel | US FDA | 1 |
| Fondaparinux | US FDA | 1 |
| Gadobutrol | US FDA | 1 |
| Gadoteric Acid | US FDA | 1 |
| Ifosfamide | US FDA | 1 |
| Iodixanol | US FDA | 1 |
| Irinotecan | US FDA | 1 |
| Rivoceranib | US FDA | 1 |
| Tolvaptan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 5 | 1 |
| ARCSA (EC) | 3 | None |
| MINSA (CR) | 2 | None |
| JFDA (JO) | 1 | None |
| NCELS (KZ) | 1 | None |
| EDE (AE) | 1 | None |
| EMA | None | 7 |
| ANVISA (Brazil) | None | 1 |
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