Amphastar Nanjing Pharmaceuticals is an API manufacturer based in China. It holds 12 active US drug master files across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| China, China | 3009805706 |
| Molecule | Regulators | Docs |
|---|---|---|
| Beclomethasone Dipropionate | US FDA | 1 |
| Budesonide | US FDA | 1 |
| Epinephrine | US FDA | 1 |
| Fluticasone Propionate | US FDA | 1 |
| Formoterol | US FDA | 1 |
| Insulin Human | US FDA | 1 |
| Ipratropium | US FDA | 1 |
| Isoprenaline | US FDA | 1 |
| Medroxyprogesterone Acetate | US FDA | 1 |
| Phylloquinone | US FDA | 1 |
| Salmeterol | US FDA | 1 |
| Teriparatide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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