Hainan Shuangcheng Pharmaceuticals is an API manufacturer based in China. It holds 7 active US drug master files and one valid CEP across a filed portfolio of 8 molecules. Its filings concentrate with US FDA and SFDA (Saudi Arabia). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Haikou City, China | Not on file |
| China, China | 3009010397 |
| Molecule | Regulators | Docs |
|---|---|---|
| Bivalirudin | SFDA (Saudi Arabia), US FDA | 2 |
| Bortezomib | US FDA | 1 |
| Eptifibatide | US FDA | 1 |
| Linaclotide | US FDA | 1 |
| Octreotide | US FDA | 1 |
| Somatostatin | EDQM | 1 |
| Triptorelin | US FDA | 1 |
| Vasopressin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 1 | 1 |
| SFDA (Saudi Arabia) | 1 | None |
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