Pharmaceutical & API manufacturing sites in Japan

148 drug establishments in Japan are registered with the US FDA; 84 (57%) list API manufacture among their operations. 102 registrant companies are identified, 13 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 33 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
148
Registered for API manufacture
84
Identified registrants
102
Current EU/UK GMP match
33

Registered operations

API manufacture84
Analytical testing83
Drug manufacture67
Labelling22
Packaging22
Sterilisation2
Particle size reduction1
Relabelling1

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

Companies headquartered in Japan

API manufacturing sites (84)

Other sites with EU/UK GMP documents (15)

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.