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.

Expertise in project management

We are focusing on delivering tailor-made solution based on analysis of your business potential. Openness and mutual respect is in core of our partnership. We have many years of experience in project management. Orientation to your goal is our priority. To ensure the best project control – you will have dedicated point of contact: Sales Manager and Project Leader.

Project Leader:

Project Leader will guide you through project evaluation and later on the person will act on your behalf to ensure that your project is completed on-time and on-budget. Thanks to high responsiveness as well as effective and transparent communication of our team you will maintain full control over your project.

Sales Manager:

Sales Manager will support you from the project creation stage up to order processing. Together you can shape your strategy and with our Sales Manager on the watch, you can be assured that the best tailor-made offer will be proposed.

Each project involves a multidisciplinary team to deliver your project: on-time and on-budget. This project team is formed by Project Leader and consists of members representing the relevant functions: R&D, Regulatory Affairs, Quality Control and Quality Assurance, Process Engineering, Tech-Transfer Team, Procurement and Supply Chain.

API PLANT LOCATED IN POLAND

API Plant

Our manufacturing plant is located in Starogard Gdański – 47 km from international airport in Gdańsk.

API Plant is constantly going through global audits & inspection. 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

Multipurpose lines

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


Equipment at API Plant

At our API Plant we can offer our experience in complex chemistries and wide range of analytical services supporting your project.

  • Phosphorus, carbohydrate and organometallic chemistry
  • Chiral, stereo and regioselective synthesis
  • Catalysis incl. phase transfer
  • Catalytic hydrogenation
  • Strong base reactions (Potassium tert-butoxide, Butyllithium)
  • Regular Organic Chemistry processes (coupling, condensations, oxidations, reductions, solvolysis etc.)
  • Grignard reactions in large scale
  • Aminoacids and Peptide Chemistry (solution and solid-phase synthesis
  • Polymorphism and solid state chemistry

We are utilizing multiple techniques:

  • X-ray diffractometer
  • Laser diffraction PSD
  • DSC, TGA
  • DVS (Dynamic Vapor Sorption)
  • Microscopy

We are using the most advances analytical techniques:

  • UPCL with detectors: UV-Vis (PDA), RI, MS, ELSD
  • SFC (Ultra-performance Supercritical Fluid Chromatography)
  • MS connected to chromatographs: EI/QD, ESI/QTof, ESI/SQD
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