Our 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.

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.

Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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