Micro Labs is an API and finished-dose manufacturer based in India. It holds 55 active US drug master files and 84 valid CEPs. Its filings concentrate with DAV (Vietnam), PPB (KE) and US FDA. Its GMP standing is certified by EMA, CDSCO (India) and NAFDAC (NG), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 30 May 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hosur, United Arab Emirates | Not on file |
| Frankfurt, Germany | Not on file |
| Frankfurt Am Main, Germany | Not on file |
| VERNA SALCETTE, India | Not on file |
| HOSUR, India | Not on file |
| BANGALORE, India | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Celecoxib | EDQM, US FDA | 8 |
| Brivaracetam | EDQM, US FDA | 5 |
| Rivaroxaban | EDQM, US FDA | 5 |
| Solifenacin Succinate | EDQM, US FDA | 5 |
| Ebastine | EDQM | 4 |
| Escitalopram | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Ticagrelor | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Acamprosate | EDQM, US FDA | 3 |
| Bisoprolol | EDQM, US FDA | 3 |
| Brimonidine | EDQM, US FDA | 3 |
| Clobazam | EDQM, US FDA | 3 |
| Dorzolamide | EDQM, US FDA | 3 |
| Glimepiride | EDQM, US FDA | 3 |
| Mirabegron | EDQM, US FDA | 3 |
| Mirtazapine | EDQM, US FDA | 3 |
| Naphazoline | EDQM, US FDA | 3 |
| Pirfenidone | EDQM, US FDA | 3 |
| Telmisartan | EDQM, US FDA | 3 |
| Timolol | EDQM, US FDA | 3 |
| Torasemide | EDQM, US FDA | 3 |
| Cyclizine | EDQM | 2 |
| Dorzolamide Hydrochloride | EDQM | 2 |
| Escitalopram Oxalate | EDQM | 2 |
| Ethambutol | EDQM | 2 |
| Ethambutol Hydrochloride | EDQM | 2 |
| Meloxicam | EDQM | 2 |
| Moxifloxacin | EDQM | 2 |
| Moxonidine | EDQM | 2 |
| Olmesartan Medoxomil | EDQM | 2 |
| Phloroglucinol | EDQM | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DAV (Vietnam) | 263 | None |
| PPB (KE) | 161 | None |
| US FDA | 130 | 4 |
| NAFDAC (NG) | 97 | 6 |
| TMDA (TZ) | 70 | 3 |
| DIGEMAPS (DO) | 68 | None |
| EMA | None | 14 |
| CDSCO (India) | None | 13 |
| ZLG (DE) | None | 4 |
| MHRA (UK) | None | 4 |
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