Suppliers / Milan Laboratories

Milan Laboratories

India 512 employees 4 duplicate records merged Updated 9 July 2026

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.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
61
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 16 June 2023 VAI US FDA
  • 6 December 2019 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

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

Filings and GMP by regulator

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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Open risk flags

  • The most recent inspection outcome was VAI, on 16 June 2023.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates