Manufacturing plant

Manufacturing plant

Our manufacturing plant located in Starogard Gdanski – 47 km from the international airport in Gdansk – is an 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 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 a different types of equipment for isolation (nutch filters, centrifuges) and drying (filter driers, tray driers,
vacuum driers). Milling and micronization to adapt particle size distribution to required customer needs.

About us Polpharma Group Polpharma API API Manufacturing sites
 

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.

CDMO Competencies & Services Quality Environmental protection Customer experience
 

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.

Generics Core competencies Products
 

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.

Technologies Cryogenic High Potent Capabilities
 

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.

Our products

Manufacturing plant

Our manufacturing plant located in Starogard Gdanski – 47 km from the international airport in Gdansk – is an 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 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 a different types of equipment for isolation (nutch filters, centrifuges) and drying (filter driers, tray driers,
vacuum driers). Milling and micronization to adapt particle size distribution to required customer needs.