Audit records

Audit records

We manufacture our products by following our customers’ and health authorities’ most stringent requirements.

Facilities for the production of APIs undergo rigorous inspections from the U.S. Food and Drug Administration (FDA). Our multipurpose plant passed FDA inspections in 2004, 2009, 2012, 2015, and, most recently, May 2018. This is something we are proud of and that confirms the highest quality standards of Polpharma.

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

Audit records

We manufacture our products by following our customers’ and health authorities’ most stringent requirements.

Facilities for the production of APIs undergo rigorous inspections from the U.S. Food and Drug Administration (FDA). Our multipurpose plant passed FDA inspections in 2004, 2009, 2012, 2015, and, most recently, May 2018. This is something we are proud of and that confirms the highest quality standards of Polpharma.