Generics

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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 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

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.

Core competencies
Products

We provide

professional support
in areas related to
technology, analytical
and special services.

We support

and help you to overcome challenges during your formulation development through solutions tailored to your needs

We collaborate

closely with you in order to
search for and suggest solutions
on a day-to-day basis working
in parallel with your technicians
and analysts to offer the best
solutions along the way.

Special services

Pack per FDF batch size

We deliver to you the API packed to a size which matches your FDF batch size.
This allows you to:

  • use for one batch the complete API package
  • avoid opening and re-opening the API packaging
  • control sensitive APIs

Quality harmonization

We provide the highest quality standards complying with global requirements. Our reliable and trusted quality system allows you to substantially reduce your QC testing of API. You can simply trust us!

QC testing according to both Ph. Eur. and USP monographs

We provide you with one batch which has been certified in accordance with the US and the Ph. EP Pharmacopeias based on your request. This will allow you to use this batch for whichever market, according to your needs.

Live Digital Tours at Polpharma API Plant

Visit us wherever you are. We offer innovative remote solutions for visits, audits, and follow-up of ongoing projects thanks to state-of-the-art virtual conference technologies. You can experience a live tour tailor-made to your needs, right from our main API facility located in Starogard Gdanski, Poland.