Cambrex Charles City is an API manufacturer based in United States. It holds 27 active US drug master files and 8 valid CEPs across a filed portfolio of 26 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Charles City, United States | Not on file |
| Charles City, United States | 1000119390 |
| Molecule | Regulators | Docs |
|---|---|---|
| Fentanyl | EDQM, US FDA | 4 |
| Amphetamine | US FDA | 3 |
| Gamma-Hydroxybutyric Acid | US FDA | 3 |
| Nicotine Resinate | EDQM, SFDA (Saudi Arabia) | 3 |
| Sulfasalazine | EDQM, US FDA | 3 |
| Dextroamphetamine | US FDA | 2 |
| Nicotine | US FDA | 2 |
| Ondansetron | EDQM, US FDA | 2 |
| Torasemide | EDQM, US FDA | 2 |
| Aripiprazole | US FDA | 1 |
| Berotralstat Dihydrochloride | SFDA (Saudi Arabia) | 1 |
| Buprenorphine | US FDA | 1 |
| Dexamfetamine Sulfate | EDQM | 1 |
| Diclofenac | US FDA | 1 |
| Erlotinib | US FDA | 1 |
| Hydrocodone | US FDA | 1 |
| Lapatinib | US FDA | 1 |
| Lisdexamfetamine Dimesylate | SFDA (Saudi Arabia) | 1 |
| Mesalazine | US FDA | 1 |
| Methylphenidate | US FDA | 1 |
| Ofloxacin | US FDA | 1 |
| Opium | US FDA | 1 |
| Remdesivir | SFDA (Saudi Arabia) | 1 |
| Sodium Oxybate | US FDA | 1 |
| Sofosbuvir | SFDA (Saudi Arabia) | 1 |
| Voxelotor | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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