Pharmaceutical & API manufacturing sites in Ireland

79 drug establishments in Ireland are registered with the US FDA; 34 (43%) list API manufacture among their operations. 60 registrant companies are identified, 5 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 51 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
79
Registered for API manufacture
34
Identified registrants
60
Current EU/UK GMP match
51

Registered operations

Analytical testing66
Drug manufacture47
API manufacture34
Packaging31
Labelling27
Repackaging5
Relabelling4
Sterilisation4
Particle size reduction1

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

Companies headquartered in Ireland

API manufacturing sites (34)

Other sites with EU/UK GMP documents (27)

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.