Roche Diagnostics GmbH

Mannheim, GermanyFEI 3002806559API manufacture registered

Roche Diagnostics GmbH is a drug establishment in Mannheim, Germany, registered with the US FDA under FEI 3002806559. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 4 EU/UK GMP certificates are matched to this site, 4 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 manufactureLabellingDrug manufacturePackaging

GMP documents matched to this site (4)

DocumentAuthorityInspectionSource
DE_BW_01_GMP_2026_0163
GMP certificate
Competent authority of Germany2 Jul 2026
within 3-year review window
EudraGMDP
DE_BW_01_GMP_2025_0250
GMP certificate
Competent authority of Germany16 Jul 2025
within 3-year review window
EudraGMDP
DE_BW_01_GMP_2025_0041
GMP certificate
Competent authority of Germany12 Dec 2024
within 3-year review window
EudraGMDP
DE_BW_01_GMP_2025_0040
GMP certificate
Competent authority of Germany12 Dec 2024
within 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