Manufacturing plant
Manufacturing plant
Our manufacturing plant located in Starogard Gdanski – 47 km from international airport in Gdansk – is a FDA
approved multipurpose facility for API and intermediates production with a total capacity exceeding 350 m3.
Polpharma is the largest Polish manufacturer of active pharmaceutical ingredients. Our substances are available in over 60 countries on six continents.
With reactor volume from 150 L to 6 000L in 6 interconnected buildings, operating in ranges from -50°C to +200°C pressure up to 10 bar, and highly
automated units for reaction parameters monitoring and control, we are being positioned among top European API CMOs. Polpharma can
accommodate a broad range of chemical processes to support customers in contract development and contract manufacturing projects.
Segregated clean areas with different type of equipment for isolation (nutch filters, centrigues) and drying (filter driers, tray driers,
vacuum driers). Milling and micronization to adapt particle size distribution to required customer needs.
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 mid-2023 with full completion scheduled for Q1 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.
Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. 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. Our products can be additionally tested in compliance with the customer’s specifications.
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 mid-2023 with full completion scheduled for Q1 2024.