Helsinn Birex Pharmaceuticals Ltd., Dublin (HBP)
Since 2009, the Helsinn Group has invested extensively in development facilities for oral solid dosage forms and a stability center to support the CMC Group activities of new solid dose products. This includes investment in highly potent material handling capability in 2018. In addition to the supply of Clinical Trial Materials, in 2014, the first new product from this facility was approved by the FDA and launched on the US market. To date, in the region of CHF 80 million has been invested in the Dublin site, and its strategic contract-manufacturing partners to provide dedicated manufacturing capacity. Together, these investments guarantee reliability of all elements of the supply chain both for development and commercial products.
Overview
- Worldwide logistic platform including Cold and Frozen Chain distribution
- Serialization of products including EU FMD and US DQSA requirements
- Building area 8,000m2 on a site area of 27,100m2
- Oral solid dosage forms, packaging of sterile and topical products
- Worldwide logistic platform including Cold Chain
- Solid-dose development and clinical supply including HPAI’s
- Stability Center (Zones I-IV, Frozen)
- Inspected and approved by HPRA on behalf of EMA and PICS and US FDA
- Employment approximately 200
