Pharmaceutical & API manufacturing sites in Austria
35 drug establishments in Austria are registered with the US FDA; 14 (40%) list API manufacture among their operations. 24 registrant companies are identified, 3 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 24 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
- 35
- Registered for API manufacture
- 14
- Identified registrants
- 24
- Current EU/UK GMP match
- 24
Registered operations
| Analytical testing | 29 |
| API manufacture | 14 |
| Drug manufacture | 13 |
| Packaging | 9 |
| Labelling | 8 |
| Repackaging | 6 |
| Relabelling | 5 |
| Sterilisation | 1 |
A site can register several operations, so these do not add up to the site total.
Companies headquartered in AustriaAPI manufacturing sites (14)
- Novartis Pharmaceutical Manufacturing GmbHLangkampfenGMP match
- Sandoz GmbHKundlGMP match
- Boehringer Ingelheim RCV GmbH & Co KGViennaGMP match
- Pfizer Manufacturing Austria GmbHOrth an der DonauGMP match
- Takeda Manufacturing Austria AGWIENGMP match
- Fresenius Kabi Austria GmbHLinzGMP match
- Loba biotech GmbHFischamendGMP match
- Novartis Pharmaceutical Manufacturing GmbHKundlGMP match
- Takeda Manufacturing Austria AGWienGMP match
- piCHEM Forschungs-und Entwicklungs GmbHRaaba-GrambachGMP match
- Polymun Scientific Immunbiologische Forschung GmbHKlosterneuburgGMP match
- Sandoz GmbHLangkampfenGMP match
- Patheon Austria GmbH & CoKGLinz
- Takeda Manufacturing Austria AGWIEN
Other sites with EU/UK GMP documents (12)
- Fresenius Kabi AustriaAustria 8055GMP match
- Intervet GESMBHWienGMP match
- LVA GmbHKlosterneuburgGMP match
- Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.ViennaGMP match
- OFI Technologie & Innovation GmbHViennaGMP match
- Takeda Austria GmbHLinzGMP match
- Takeda Manufacturing Austria AGWienGMP match
- Takeda Manufacturing Austria AGWienGMP match
- Valneva Austria GmbHViennaGMP match
- VelaLabs GmbHViennaGMP match
- ViruSure Forschung und Entwicklung GmbHViennaGMP match
- ViruSure Forschung und Entwicklung GmbHViennaGMP 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.