We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.
Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.
We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.
A new greenfield R&D and production facility dedicated to HP API products with OEL down to 10ng/m3 3(OEB 6) will be launched in Q3 of 2024.
The plant capabilities shall provide GMP and FDA-approved kilo-scale production of batch sizes up to 1,5 kg together with separate analytical (ADL) and process development laboratories (PDL).
Full GMP
R&D: Process Development Lab Analytical Laboratory
GMP Kilo-Lab production
The use of hazardous chemistry has an aim to reduce the number of synthesis steps as well as the number
of impurities. Our key hazardous chemistry includes:
