ITM Medical Isotopes GmbH

Garching b. M�nchen, GermanyFEI 3010531211API manufacture registered

ITM Medical Isotopes GmbH is a drug establishment in Garching b. M�nchen, Germany, registered with the US FDA under FEI 3010531211. Its registered operations are: Analytical testing, API manufacture, PET drug production. 8 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 manufacturePET drug production

GMP documents matched to this site (8)

DocumentAuthorityInspectionSource
DE_BY_04_GMP_2026_0137
GMP certificate
Competent authority of Germany9 Feb 2026
within 3-year review window
EudraGMDP
DE_BY_04_GMP_2026_0061
GMP certificate
Competent authority of Germany18 Mar 2025
within 3-year review window
EudraGMDP
DE_BY_04_GMP_2025_0121
GMP certificate
Competent authority of Germany18 Mar 2025
within 3-year review window
EudraGMDP
DE_BY_04_GMP_2025_0112
GMP certificate
Competent authority of Germany18 Mar 2025
within 3-year review window
EudraGMDP
DE_BY_04_GMP_2023_0174
GMP certificate
Competent authority of Germany12 Jul 2023
outside 3-year review window
EudraGMDP
DE_BY_04_GMP_2024_0113
GMP certificate
Competent authority of Germany12 Jul 2023
outside 3-year review window
EudraGMDP
DE_BY_04_GMP_2024_0131
GMP certificate
Competent authority of Germany21 Jun 2023
outside 3-year review window
EudraGMDP
DE_BY_04_GMP_2023_0152
GMP certificate
Competent authority of Germany21 Jun 2023
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.