Pharmaceutical & API manufacturing sites in Czech Republic
25 drug establishments in Czech Republic are registered with the US FDA; 10 (40%) list API manufacture among their operations. 19 registrant companies are identified; sites whose registrant is not resolved to a company profile are not counted. 15 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
- 25
- Registered for API manufacture
- 10
- Identified registrants
- 19
- Current EU/UK GMP match
- 15
Registered operations
| Analytical testing | 15 |
| API manufacture | 10 |
| Drug manufacture | 7 |
| Labelling | 4 |
| Packaging | 4 |
| Sterilisation | 1 |
| Distribution | 1 |
| Particle size reduction | 1 |
| Relabelling | 1 |
| Repackaging | 1 |
A site can register several operations, so these do not add up to the site total.
API manufacturing sites (10)
- Synthon s.r.o.BlanskoGMP match
- Contipro a.s.Dolni DobroucGMP match
- Macco Organiques, S.r.o.BruntalGMP match
- Teva Czech Industries s.r.o.OpavaGMP match
- VUAB Pharma A.S.RoztokyGMP match
- Cayman Pharma s.r.o.NeratoviceGMP match
- Synthesia, a.s.PardubiceGMP match
- CZECH-GEN, a.s.Olomouc - Klasterni Hradisko
- Symeres CZ, s.r.o.Praha 9
- TAPI Czech Industries s.r.oOpava
Other sites with EU/UK GMP documents (8)
- ALS Czech Republic, s.r.o.Praha 9 - VysocanyGMP match
- Biomedica, spol. s r.o.Hor�tevGMP match
- Ekocentrum Ovalab, s.r.o.Ostrava- MartinovGMP match
- Eurofins BioPharma Product Testing Czech Republic s.r.o.BrnoGMP match
- Itest plus, s.r.o.Hradec KraloveGMP match
- medac pharma production a.s.BrnoGMP match
- Quinta-Analytica s.r.o.Prague 10GMP match
- Statni Veterinarni Ustav OlomoucOlomouc - Nove SadyGMP match
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.