Ampac Fine Chemicals is an API and finished-dose manufacturer based in United States. It holds 9 active US drug master files and one valid CEP across a filed portfolio of 13 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 September 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Rancho Cordova, United States | Not on file |
| El Dorado Hills, United States | 3013339335 |
| RANCHO CORDOVA, United States | 2918710 |
| Molecule | Regulators | Docs |
|---|---|---|
| Carmustine | EDQM, US FDA | 2 |
| Brigatinib | SFDA (Saudi Arabia) | 1 |
| Cyclophosphamide | US FDA | 1 |
| Dexmethylphenidate | US FDA | 1 |
| Levorphanol | US FDA | 1 |
| Methylphenidate | US FDA | 1 |
| Oseltamivir | US FDA | 1 |
| Remifentanil | US FDA | 1 |
| Ruxolitinib | SFDA (Saudi Arabia) | 1 |
| Sofosbuvir | SFDA (Saudi Arabia) | 1 |
| Sotorasib | SFDA (Saudi Arabia) | 1 |
| Tapentadol | US FDA | 1 |
| Temozolomide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 4 | None |
| US FDA | None | 2 |
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