Pharmaceutical & API manufacturing sites in Italy

180 drug establishments in Italy are registered with the US FDA; 90 (50%) list API manufacture among their operations. 118 registrant companies are identified, 15 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 139 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
180
Registered for API manufacture
90
Identified registrants
118
Current EU/UK GMP match
139

Registered operations

Analytical testing118
API manufacture90
Drug manufacture84
Packaging59
Labelling45
Sterilisation9
Particle size reduction2
Relabelling1
Repackaging1

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

Companies headquartered in Italy

API manufacturing sites (90)

Other sites with EU/UK GMP documents (66)

All 156 published sites in Italy, 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.