Milan Laboratories is a finished-dose manufacturer based in India. It appears in 61 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with EFDA (ET), NMRC (NA) and TMDA (TZ). Its GMP standing is certified by EMA, CDSCO (India) and MHRA (UK), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 16 June 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| DAHEJ, India | Not on file |
| MUMBAI, India | Not on file |
| Panvel, India | Not on file |
| Dahej, India | Not on file |
| Dahej, India | 3014919100 |
| dahej 392 130bharuch, India | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EFDA (ET) | 23 | None |
| NMRC (NA) | 19 | None |
| TMDA (TZ) | 11 | None |
| NAFDAC (NG) | 6 | None |
| BOMRA (BW) | 2 | None |
| EMA | None | 3 |
| CDSCO (India) | None | 2 |
| MHRA (UK) | None | 2 |
| US FDA | None | 1 |
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