Yangtze River Pharmaceutical Group Jiangsu Haici Biological Pharmaceutical is an API manufacturer based in China. It holds 25 active US drug master files across a filed portfolio of 25 molecules. Its filings concentrate with NPRA (MY), AEMPS (ES) and MINSA (CR). Its GMP standing is certified by EMA.
| Site | FDA FEI |
|---|---|
| Taizhou, China | Not on file |
| China, China | 3009173840 |
| China, China | 3030810525 |
| Molecule | Regulators | Docs |
|---|---|---|
| Afatinib | US FDA | 1 |
| Aripiprazole | US FDA | 1 |
| Dexmedetomidine | US FDA | 1 |
| Dexrazoxane | US FDA | 1 |
| Diquafosol | US FDA | 1 |
| Doxofylline | US FDA | 1 |
| Edaravone | US FDA | 1 |
| Empagliflozin | US FDA | 1 |
| Esomeprazole | US FDA | 1 |
| Gemcitabine | US FDA | 1 |
| Glimepiride | US FDA | 1 |
| Lenalidomide | US FDA | 1 |
| Lenvatinib | US FDA | 1 |
| Levosimendan | US FDA | 1 |
| Linagliptin | US FDA | 1 |
| Milrinone | US FDA | 1 |
| Parecoxib | US FDA | 1 |
| Pramipexole | US FDA | 1 |
| Propofol | US FDA | 1 |
| Regorafenib | US FDA | 1 |
| Sitafloxacin | US FDA | 1 |
| Sugammadex | US FDA | 1 |
| Tamoxifen | US FDA | 1 |
| Tedizolid | US FDA | 1 |
| Tofacitinib | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| NPRA (MY) | 10 | None |
| AEMPS (ES) | 3 | None |
| MINSA (CR) | 2 | None |
| ARCSA (EC) | 1 | None |
| EMA | None | 1 |
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