Suppliers / Merck S.A. de C.V

Merck S.A. de C.V

Mexico 2 duplicate records merged Updated 9 July 2026

Merck S.A. de C.V is a finished-dose manufacturer based in Mexico. It appears in 32 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), INVIMA (CO) and COFEPRIS (MX). Its GMP standing is certified by ANVISA (Brazil), EMA and COFEPRIS (MX). Its most recent recorded inspection, by US FDA, closed on 30 January 2015 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
32
filings across 3 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

  • 30 January 2015 VAI US FDA
  • 23 August 2013 VAI US FDA

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

Registered plants

Site FDA FEI
Naucalpan, Colombia Not on file
NAUCALPAN DE JUAREZ, Mexico Not on file
Naucalpan, Mexico Not on file
Mexico, Mexico 3004641553
Naucalpan de Juárez, Mexico Not on file
Cuautitlán Izcalli, Mexico Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 29 None
INVIMA (CO) 2 None
COFEPRIS (MX) 1 2
ANVISA (Brazil) None 3
EMA None 2

Questions about Merck S.A. de C.V

Does Merck S.A. de C.V hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Merck S.A. de C.V. It does have 32 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Merck S.A. de C.V FDA-registered?
One site operated by Merck S.A. de C.V 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 Merck S.A. de C.V's last inspection go?
The most recent inspection on record closed on 30 January 2015 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Merck S.A. de C.V manufacture?
6 registered sites are on record, in Colombia and Mexico (Naucalpan, Naucalpan DE Juarez and Mexico among others). Every site is listed on this page with the register it came from.
Which regulators recognise Merck S.A. de C.V's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA and COFEPRIS (MX). 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 30 January 2015.

Comparable suppliers

Abbott Laboratories De México, S. A. De C. V also in Mexico Armstrong Laboratorios De México, S.A. De C.V also in Mexico Bayer De Mexico, S.A. De C.V also in Mexico Fermic, s.a. de c.v also in Mexico Grimann, S.A. de C.V also in Mexico

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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