European CDMO Partner
and API Manufacturer
since 1951

FDA-APPROVED AND
cGMP-COMPLIANT PRODUCTION SITE

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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 mid-2023 with full completion scheduled for Q1 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
 

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.

Technologies Cryogenic High Potent Capabilities
 

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.

Our products
CDMO
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Polpharma Group
Polpharma API
API Manufacturing sites

Polpharma Group

For over 80 years, trusted by patients, healthcare professionals, and business partners alike. A leading regional (CEE and CIS) manufacturer of pharmaceuticals and a leader in the Polish & Kazakhstan pharmaceutical market. Actively operating in Central and Eastern Europe, the Caucasus, and Central Asia markets.

Polpharma is one of the frontrunners in transforming the healthcare industry in terms of advanced commercial models, use of AI in industrial and other areas to further improve both the closeness to the HCP professionals and patients and its effectiveness.