Pharmaceutical & API manufacturing sites in Malta
7 drug establishments in Malta are registered with the US FDA; 3 (43%) list API manufacture among their operations. 6 registrant companies are identified; sites whose registrant is not resolved to a company profile are not counted. 6 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
- 7
- Registered for API manufacture
- 3
- Identified registrants
- 6
- Current EU/UK GMP match
- 6
Registered operations
| Analytical testing | 6 |
| Drug manufacture | 3 |
| Packaging | 3 |
| API manufacture | 3 |
| Labelling | 1 |
A site can register several operations, so these do not add up to the site total.
API manufacturing sites (3)
- Amino Chemicals LtdMarsaGMP match
- Sterling Chemical Malta LtdBirzebbugaGMP match
- Medichem Manufacturing (Malta) LimitedBirzebbugaGMP match
Other sites with EU/UK GMP documents (4)
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.