Topharman Shandong is an API manufacturer based in China. It holds 9 active US drug master files and one valid CEP across a filed portfolio of 9 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 17 May 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Weifang, China | Not on file |
| Anqiu City, China | Not on file |
| China, China | 3010708767 |
| Molecule | Regulators | Docs |
|---|---|---|
| Tadalafil | EDQM, US FDA | 2 |
| Aripiprazole | US FDA | 1 |
| Brexpiprazole | US FDA | 1 |
| Dapoxetine | US FDA | 1 |
| Efinaconazole | US FDA | 1 |
| Neratinib | US FDA | 1 |
| Rivaroxaban | US FDA | 1 |
| Tecovirimat | US FDA | 1 |
| Telmisartan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 1 |
| US FDA | None | 1 |
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