Merck & Cie KmG

Altdorf, SwitzerlandFEI 3004369363API manufacture registered

Merck & Cie KmG is a drug establishment in Altdorf, Switzerland, registered with the US FDA under FEI 3004369363. Its registered operations are: Analytical testing, API manufacture, Labelling, Packaging. 6 EU/UK GMP certificates are matched to this site, 5 inspected within the last three years.

Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology

Registered operations

Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.

Analytical testingAPI manufactureLabellingPackaging

GMP documents matched to this site (6)

DocumentAuthorityInspectionSource
GMPEHV-CH-1008834
GMP certificate
Competent authority of Switzerland26 Mar 2026
within 3-year review window
EudraGMDP
GMPEHV-CH-1007156
GMP certificate
Competent authority of Switzerland6 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1007651
GMP certificate
Competent authority of Switzerland7 Mar 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1005894
GMP certificate
Competent authority of Switzerland7 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1005864
GMP certificate
Competent authority of Switzerland7 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1004298
GMP certificate
Competent authority of Switzerland30 Mar 2022
outside 3-year review window
EudraGMDP

A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.

What this page does not show

  • Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
  • Capacity, scale, price or current availability: no regulator publishes these.
  • FDA inspection classifications for this site, which are not yet linked.

Other sites registered by the same company