Pharmaceutical & API manufacturing sites in India

1,043 drug establishments in India are registered with the US FDA; 554 (53%) list API manufacture among their operations. 667 registrant companies are identified, 93 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 191 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
1,043
Registered for API manufacture
554
Identified registrants
667
Current EU/UK GMP match
191

Registered operations

Analytical testing558
API manufacture554
Drug manufacture362
Packaging252
Labelling175
Sterilisation28
Repackaging15
Relabelling9
Particle size reduction4
Transfilling (medical gases)1

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

Companies headquartered in India

API manufacturing sites (554)

Showing 120 of 554, GMP-matched sites first; the full list is linked below.

Other sites with EU/UK GMP documents (132)

All 686 published sites in India, 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.