Fine Chemicals Corporation (PTY) is an API manufacturer based in South Africa. It holds 16 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with MINSA (CR) and EEC_EAEU. Its GMP standing is certified by ZLG (DE), SAHPRA (ZA) and US FDA. Its most recent recorded inspection, by US FDA, closed on 4 April 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Bremen, Germany | Not on file |
| Arada Sub City, Ethiopia | Not on file |
| South Africa, South Africa | 3002806969 |
| Cape Town, South Africa | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Azathioprine | US FDA | 2 |
| Baclofen | US FDA | 2 |
| Fluphenazine | US FDA | 2 |
| Ropivacaine | US FDA | 2 |
| Benzatropine | US FDA | 1 |
| Levosalbutamol | US FDA | 1 |
| Methazolamide | US FDA | 1 |
| Penbutolol | US FDA | 1 |
| Remifentanil | US FDA | 1 |
| Scopolamine | US FDA | 1 |
| Thiothixene | US FDA | 1 |
| Vincristine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 3 | None |
| EEC_EAEU | 1 | None |
| ZLG (DE) | None | 2 |
| SAHPRA (ZA) | None | 2 |
| US FDA | None | 1 |
Choose your molecules and target markets. Fine Chemicals Corporation (PTY) comes back tiered against every other supplier able to file there.
Start for free