Pharmaceutical & API manufacturing sites in South Korea

155 drug establishments in South Korea are registered with the US FDA; 41 (26%) list API manufacture among their operations. 141 registrant companies are identified, 3 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 1 published site is 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
155
Registered for API manufacture
41
Identified registrants
141
Current EU/UK GMP match
1

Registered operations

Drug manufacture120
Labelling43
API manufacture41
Packaging27
Analytical testing25
Relabelling3
Repackaging1

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

Companies headquartered in South Korea

API manufacturing sites (41)

Other sites with EU/UK GMP documents (1)

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.