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, MHRA (UK) and CDSCO (India), 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 392 130bharuch, India Not on file
Dahej, India 3014919100

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
MHRA (UK) None 2
CDSCO (India) None 2
US FDA None 1

Questions about Milan Laboratories

Does Milan Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Milan Laboratories. It does have 61 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Milan Laboratories FDA-registered?
One site operated by Milan Laboratories carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Milan Laboratories's last inspection go?
The most recent inspection on record closed on 16 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Milan Laboratories manufacture?
6 registered sites are on record, in India (Dahej, Mumbai and Panvel among others). Every site is listed on this page with the register it came from.
Which regulators recognise Milan Laboratories's GMP?
Current GMP certificates are on record from EMA, MHRA (UK), CDSCO (India) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

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Sources on this page

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