Pharmaceutical & API manufacturing sites in Germany

248 drug establishments in Germany are registered with the US FDA; 85 (34%) list API manufacture among their operations. 187 registrant companies are identified, 8 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 159 published sites are matched to an EU or UK GMP certificate inspected within the last three years.

Counts are physical site addresses in the FDA's current establishment register (US-facing sites only), not headquarters and not production volume. Methodology

FDA-registered sites
248
Registered for API manufacture
85
Identified registrants
187
Current EU/UK GMP match
159

Registered operations

Analytical testing171
Drug manufacture99
API manufacture85
Packaging76
Labelling67
Sterilisation14
Repackaging10
Particle size reduction6
Relabelling5
PET drug production2

A site can register several operations, so these do not add up to the site total.

Companies headquartered in Germany

API manufacturing sites (85)

Other sites with EU/UK GMP documents (103)

All 188 published sites in Germany, A–Z

Only sites registered with the US FDA appear, so manufacturing that serves only other markets is missing and these figures understate national capacity. A GMP match requires the certificate address to name the site's street and its city or postcode; an unmatched site is not an uncertified site.