Pharmaceutical & API manufacturing sites in China

1,139 drug establishments in China are registered with the US FDA; 512 (45%) list API manufacture among their operations. 1,002 registrant companies are identified, 21 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 84 published sites are matched to an EU or UK GMP certificate inspected within the last three years, and 1 carries an EU GMP non-compliance statement.

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
1,139
Registered for API manufacture
512
Identified registrants
1,002
Current EU/UK GMP match
84

Registered operations

Drug manufacture619
API manufacture512
Labelling315
Analytical testing250
Packaging139
Repackaging24
Sterilisation23
Relabelling14
Medicated animal feed6
Particle size reduction5

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

Companies headquartered in China

API manufacturing sites (512)

Showing 120 of 512, GMP-matched sites first; the full list is linked below.

Other sites with EU/UK GMP documents (27)

All 539 published sites in China, 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. Non-compliance statements may since have been closed out; check each source record.