Pharmaceutical & API manufacturing sites in Poland
20 drug establishments in Poland are registered with the US FDA; 8 (40%) list API manufacture among their operations. 17 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. 5 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
- 20
- Registered for API manufacture
- 8
- Identified registrants
- 17
- Current EU/UK GMP match
- 5
Registered operations
| Analytical testing | 10 |
| API manufacture | 8 |
| Drug manufacture | 7 |
| Labelling | 5 |
| Packaging | 4 |
| Relabelling | 1 |
| Repackaging | 1 |
| Sterilisation | 1 |
A site can register several operations, so these do not add up to the site total.
Companies headquartered in PolandAPI manufacturing sites (8)
- NARODOWE CENTRUM BADAN JADROWYCHOtwockGMP match
- Polpharma Biologics S.A.DuchniceGMP match
- Polpharma Biologics S.A.GdanskGMP match
- ANIMEX FOODS SP Z O O ODDZIAL W STARACHOWICACHStarachowice
- Biopharmacotech Sp Z O OWozniki
- JOST CHEMICAL POLAND SP Z O OKoscian
- NOBILUS ENT ODDZIAL KUTNOKutno
- ZAKLADY FARMACEUTYCZNE POLPHARMA S AStarogard Gdanski
Other sites with EU/UK GMP documents (2)
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.