Pharmaceutical & API manufacturing sites in Hungary
11 drug establishments in Hungary are registered with the US FDA; 10 (91%) list API manufacture among their operations. 9 registrant companies are identified, 1 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 3 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
- 11
- Registered for API manufacture
- 10
- Identified registrants
- 9
- Current EU/UK GMP match
- 3
Registered operations
| API manufacture | 10 |
| Analytical testing | 10 |
| Packaging | 4 |
| Drug manufacture | 3 |
| Labelling | 2 |
| Repackaging | 1 |
A site can register several operations, so these do not add up to the site total.
Companies headquartered in HungaryAPI manufacturing sites (10)
- Xellia Pharmaceuticals Ltd.BudapestGMP match
- EGIS Pharmaceuticals PLCBudapestGMP match
- ALKALOIDA Vegyeszeti Gyar zartkoruen mukodo ReszvenytarsasagTiszavasvari
- EUROAPI Hungary Ltd.Budapest
- Gedeon Richter Plc., Dorog siteDorog
- Richter Gedeon Nyrt.Budapest
- Richter Gedeon Nyrt.-Debrecen, Richter Gedeon utca 20. alatti telephelyDebrecen
- TAPI Hungary Industries LtdDebrecen
- TAPI Hungary Industries Ltd - Saj�b�bony, 024/180 hrsz. alatti telephelySaj�b�bony
- Teva Pharmaceutical Works Private Limited CompanyDebrecen
Other sites with EU/UK GMP documents (1)
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.