Enaltec Labs is an API and finished-dose manufacturer based in India. It holds 22 active US drug master files across a filed portfolio of 19 molecules. Its filings concentrate with CDSCO (India) and MINSA (CR). Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 27 March 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Thane, India | 3006599894 |
| Molecule | Regulators | Docs |
|---|---|---|
| Phylloquinone | US FDA | 4 |
| Chlorpromazine | US FDA | 2 |
| Clonidine | US FDA | 2 |
| Dofetilide | US FDA | 2 |
| Fluphenazine | US FDA | 2 |
| Midodrine | US FDA | 2 |
| Neostigmine | US FDA | 2 |
| Ramelteon | US FDA | 2 |
| Trospium | US FDA | 2 |
| Varenicline | US FDA | 2 |
| Alcaftadine | SFDA (Saudi Arabia) | 1 |
| Brimonidine | SFDA (Saudi Arabia) | 1 |
| Dalfampridine | SFDA (Saudi Arabia) | 1 |
| Dimethyl | SFDA (Saudi Arabia) | 1 |
| Montelukast | SFDA (Saudi Arabia) | 1 |
| Moxifloxacin | SFDA (Saudi Arabia) | 1 |
| Rosuvastatin | SFDA (Saudi Arabia) | 1 |
| Strontium Ranelate | SFDA (Saudi Arabia) | 1 |
| Timolol | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 5 | None |
| MINSA (CR) | 4 | None |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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