Your challenge, our solutions

Polpharma Group operates in the international pharmaceutical market for over 80 years. Our goal has always been to provide high quality APIs, and now we do the same with CDMO projects.

Polpharma as a European API producer with cGMP compliant and FDA-approved multipurpose facilities offers individual approach to each CDMO project. We constantly pursuit of offering tailor-made solutions to be your long-term API CDMO supplier and partner at the same time.

We are able to deliver synergy between complex chemistry and analytical development laboratory, to enable cooperation tailored to individual needs, for use as pharmaceuticals and cosmetics.

  • 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

Our project management team focus on delivering tailor-made solutions based on the analysis of your business potential.

We brings our State Of The Art R&D Facilities with knowledge that adds real value to your development and production projects at every stage.

To ensure the best project control – you will have dedicated point of contact: Project Leader (technology transfer & product launch) and Sales Manager (commercial issues). The transparent structure keep you informed the progress: from project draft to project launch, ensuring the delivery of the project on time and budget.

Check how we can support you by clicking on the area of your interest:

Project Evaluation:

Their primary objective is to understanding your needs and then delivery of the project: ON TIME & ON BUDGET.

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.

 

US FDA-approved European API producer

380 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. —50°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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