About us

We deliver quality

API Polpharma is a significant European producer of Active Pharmaceutical Ingredients delivering products to pharmaceutical companies worldwide. We are present on 6 continents, in 60+ countries, and our market share is constantly growing. Our well-balanced and expanding portfolio, along with our scientific know-how and experience, allow us to offer attractive solutions for drug developers.

We provide a one-stop shop solution of vertically integrated services from API development to FDF formulation and manufacturing, scale-up capabilities based on in-house or external custom developed technologies, to regulatory support.

Regular FDA audits enabled us to register and sell a number of APIs in the US market and confirm our reliability and credibility towards our business partners around the world. At Polpharma quality comes first.

Our history

  • 1935

    Polpharma's foundation - manufacturing on Bayer technology

  • 1939

    Taken over by Bayer

  • 1949

    Reconstruction of Polpharma after The Secound World War

  • 1949

    First product after the war - redistrilled water in glass ampoules

  • 1951

    Minister of Industry established Starogard Pharmaceutical Plant, making salicylates and sulfonamides.

  • 1959

    Plant becomes part of Union Of Pharmaceutical Industry and renames to Pharmaceutical Works "Polfa" Starogard

  • 1995

    ,,Polfa" Starogard transformed into a Join Stock Company with 100% shares belonging to the State Treasury

  • 1995

    Company returned to its old name - Pharmaceutical Works POLPHARMA S.A.

  • 2000

    Spectra Holding and Prokom Investments (Polish capital) bought the majority of the Company shares converting it to a private company

  • 2007

    Strategic alliance with Akrikhin, major generic pharma player in the Russian market

  • 2010

    Acquisition of antibiotic business of Bioton Poland together with a cephalosporin manufacturing plant in Duchnice, Poland

  • 2011

    Polpharma becomes a key partner of Chimpharm, Kazahstan

  • 2012

    Polpharma becomes a major shareholder of Polfa Warsaw, Poland

  • 2012

    First laboratories are opened in a biotech center in the Gdańsk Science and Technology Park

  • 2014

    Decision about building BIOTECH Manufacturing facility in Duchnice

  • 2017

    Decision about Parental Manufacturing consolidation and building new facility for sterile products in Starogard

  • 2018

    FDA audyt for API Plant

  • 2019

    Spin-off of Biotech buissness as Polpharma Biologics SA

  • 2019

    Completion of the investment in Sieradz (non-sterile liquids)

  • 2020

    Integration IPOCHEM to Polpharma API

Core competences

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. However, our products can be additionally tested in compliance with the customer’s specifications.

We offer solutions tailored to your needs:

Values
Expertise
& experience
Regulatory
service
Intellectual
property

Capabilities

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. However, our products can be additionally tested in compliance with the customer’s specifications.

Solid state
chemistry
Hazardous
chemistry
Our
capacity
Green
chemistry
Production
facilities
Network
of alliances

We invest with your future in mind

A completely rebuilt and modernized production facility for the production of API was put into operation in February 2017 extending our production capacity.We invest in innovative technologies which enhance production efficiency, the comfort of medication delivery and safety of our processes for humans and the environment

Our newly modernized facility is compliant with the highest manufacturing standards. Equipment delivered by globally recognized suppliers ensures safety of API production in conformity with Polpharma quality standards as well as increasing cGMP requirements. Our production area has been designed to enable parallel manufacturing of API on two additional production lines

Tailored solutions

Professional
and experienced team

Team of key account managers guarantee customized service packages for each client. We are here to advise in project evaluation, educate our clients about our technology and recommend appropriate solutions. We provide assistance in every step of the purchasing process.

Control over your product

The scope of our services includes preparation of comprehensive regulatory documentation in an eCTD format.

The process is performed by the R&D, RA, QA and other Operational departments of Polpharma. All of this with the sole purpose of maintaining full control over your product.

Full support

Polpharma API offers full support from process optimization, analytical method development & validation, to process scale-up to pilot plant (kg scale) and fully commercial, multiple tons synthesis in EU cGMP, FDA (US), Anvisa (Brazil), PMDA (Japan) & KFDA (Korea) approved facility.

Quality, optimization and customer satisfaction are the driving forces behind our work

  • Full support from molecule development to drug delivery

  • Development and production of generic APIs

  • Custom synthesis and toll manufacturing

  • Intellectual Property expertise and guidance

  • Regulatory compliance

  • Process upscaling

  • Development of new salts and polymorphic forms of APIs

  • Adjusted particle size distribution (PSD)

  • Non-infringing process development

  • Multipurpose production lines

  • High GMP standards

  • High quality products

  • Excellent service

  • Wide reaction classes in FDA approved facilities

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