Merck Healthcare KGaA

Darmstadt, GermanyFEI 3016570199

Merck Healthcare KGaA is a drug establishment in Darmstadt, Germany, registered with the US FDA under FEI 3016570199. Its registered operations are: Analytical testing, Labelling, Drug manufacture, Packaging. 5 EU/UK GMP certificates are matched to this site, 3 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 testingLabellingDrug manufacturePackaging

GMP documents matched to this site (5)

DocumentAuthorityInspectionSource
DE_HE_01_GMP_2026_0177
GMP certificate
Competent authority of Germany24 Jun 2026
within 3-year review window
EudraGMDP
DE_HE_01_GMP_2024_0266
GMP certificate
Competent authority of Germany29 Nov 2024
within 3-year review window
EudraGMDP
DE_HE_01_GMP_2026_0043
GMP certificate
Competent authority of Germany29 Nov 2024
within 3-year review window
EudraGMDP
DE_HE_01_GMP_2024_0185
GMP certificate
Competent authority of Germany13 May 2022
outside 3-year review window
EudraGMDP
DE_HE_01_GMP_2023_0166
GMP certificate
Competent authority of Germany13 May 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