Your challenge, our solutions

Polpharma as a European API producer with cGMP compliant and FDA-approved multipurpose facilities is providing CDMO service.

  • Our custom development and manufacturing services are dedicated to clients looking for a European manufacturing site for their active substances.
  • With broad experience in complex chemistries, dedicated project management and R&D team, corporate quality system and service excellence.
  • We have a successful track record in Development, Technology Transfer and Commercialization in regulated markets. We are focused on Projects from Phase IIa CTM’s onwards.

New requirements and guidelines appear every year. The pharmaceutical environment enforces highest possible quality of your products. In order to maintain the position of one of the best on the market, we not only follow requirements but we are ahead of them.

We guarantee your peace of mind

Professional project management team coordinates for you all project activities performed by the R&D, RA, QA and other Operational departments of Polpharma. All of this with the sole purpose of you maintaining a full control over your product. Check more.

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Expertise

At each stage of our partnership you will cooperate with dedicated Project Leader. Project Leader will guide you through project evaluaton and later on the person will act on your behalf to ensure that your project is completed on-tme and on-budget. Thanks to high responsiveness as well as effectve and transparent communicaton of our team you will maintain full control over your project.

API Plant

Our manufacturing plant is located in Starogard Gdański:

  • 47 km from international airport in Gdański
  • 64 km from major ports
  • Our multipurpose API plant passed FDA inspections in 2004, 2009, 2012, 2015 and, most recently, in May 2018.

FDA approved European API producer

300 Employees at API Plant

Professional project management team

Glass lined
338 m3
177 reactors
Stainless steel
(hastelloy C22 / AISI 316L)
38 m3
18 reactors
Auxiliary tanks
200 m3
Tank Farm
1050 m3

Equipment type

Reactors Columns Crystallizers Centrifuges Dryers Filter-dryers Mills Micronizers

Operating ranges
Commercial Scale

Temp. —50°C to +200°C Pressure —1 to +10 bars pH in the full range

Operating ranges
Pilot Plant

Temp. —80°C to +200°C Pressure —1 to +10 bars pH in the full range

Wide range of analytical services supporting your project

For more information please contact us or use our contact form

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