Hovione today announced that its API plant in Cork has successfully passed a pre-approval inspection by the FDA
The Hovione Cork site was acquired from Pfizer in 2009. The focus of this plant is Contract Manufacturing offering both drug substance and particle engineering. The plant has been regularly inspected by the FDA and the Health Products Regulatory Authority (formely IMB).
“HE is unique, it combines hard to find capacity and quality people”
US Biotech, West Coast
The site has extensive facilities for drug substance manufacturing with approximately 430 cubic meters of state of the art cGMP capacity and the potential for 12 discrete process trains. The site houses the largest commercial pharmaceutical spray dryer available on the market, a Niro PSD-5, that is particularly suited for large volume products.
Areas of Focused Expertise
The site has leading capabilities and physical assets in the following areas:
- Cryogenic (Volume 8000L to 10,000L, Temperature Range -150 to 120ºC)
- Hydrogenation (Volume 2500L to 6000L, Pressure Rating 6 to 12 bar)
- Large scale spray drying (PSD5)
- Pyrophoric compound handling (2 stations)
For details about production equipment – click here
- The Cork plant operates 24 hours a day 7 days a week.
- Quality Control labs supports production 24 hours a day 7 days a week.
- Plant maintenance shutdown period takes place for 2 to3 weeks in August.