Polpharma S.A.

About Polpharma S.A.

Polpharma Group. European business partner for pharmaceutical companies worldwide. Diversified business oportunities - API, CDMO, OL, In-licensing - supported by professional services and competencies dedicated to the B2B partners to grow beyond the scale together. We are offering environment for collaboration, support from qualified experts and state-of-the-art facilities. We are actively looking for partners in all of our activity areas – from product development stage, through production and commercial cooperation, to other forms of partnership.

Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI 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 QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

Certifications
  • PL
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Contact info
Meet us at

CPHI North America 2024

Pennsylvania Convention Center, Philadelphia
07 May 2024 - 09 May 2024

CPHI Milan 2024

Fiera Milano, Italy
08 Oct 2024 - 10 Oct 2024

Products from Polpharma S.A. (15)

  • Ticagrelor

    Product Ticagrelor

    Ticagrelor 

    form II 

    Own process patent to free from nitrosamines 

    CEP, 
    US DMF, 
    EU DMF,  
    Korean DMF, 
    Canadian DMF, 
    Cadifa
  • Hydrochlorothiazide

    Product Hydrochlorothiazide

    Hydrochlorothiazide

    Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 17599 available • Japanese DMF available  • CEP available
    Indication: Hydrochlorothiazide is a diuretic drug of the thiazide class that acts by inhibiting the kidneys' abilit...
  • Alendronate sodium

    Product Alendronate sodium

    Alendronate Sodium
    Trihydrate

    > No risk of presence of nitrosamines
    > Long experience with commercial manufacturing
    > In-house production of the whole product family (Risedronate, Alendronate, Ibandronate)

    CEP, 
    US DMF, 
    JAP...
  • Pentoxifylline

    Product Pentoxifylline

    Pentoxifylline
    Form I

    > Very long production experience
    > Tailor made PSD

    CEP, 
    US DMF, 
    CHINESE


    This product is not offered for sale or made available in countries where it is subject to patent (SPC) protection and wher...
  • Dapagliflozin

    Product Dapagliflozin

    Dapagliflozin

    > Cryogenic process
    > Green Chemistry

    EU DMF
    US DMF
    Korean DMF
    Canadian DMF 

    Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes in...
  • Enzaluthamide

    Product Enzaluthamide

    Enzalutamide 
    Anhydrous form R1 

    CAS No: 915087-33-1
    Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not ...
  • Palbociclib

    Product Palbociclib

    Palbocyclib

    CRYSTAL FORM A
    US DMF pending


    Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sal...
  • Apixaban

    Product Apixaban

    Apixaban

    Polymorphic form N-1

    > No risk of nitrosamines > Eco friendly process
    > PSD flexibility via micronization

    EU DMF, 
    US DMF, 
    KOREAN DMF


    Products protected by patents (SPC) in Poland are develope...
  • Empagliflozin

    Product Empagliflozin

    Empagliflozin

    CRYSTALLINE ANHYDROUS

    > Cryogenic process
    > Green chemistry

    EU DMF, 
    US DMF, 
    CHINESE DMF, 
    KOREAN DMF



    Products protected by patents (SPC) in Poland are developed solely for t...
  • Baclofen

    Product Baclofen

    Baclofen
    FORM B

    Own innovative process

    Global market leader
    CEP, US 
    DMF, 
    JAPANESE DMF, 
    KOREAN DMF, 
    CANADIAN DMF
    This product is not offered for sale or made available in countries where it is subject to patent (S...
  • Rivaroxaban

    Product Rivaroxaban

    Rivaroxaban

    MODIFICATION I

    > No risk of presence of nitrosamines
    > Innovative crystalization obtaining material of high purity

    CEP, 
    US DMF, 
    CHINESE DMF, 
    KOREAN DMF 


    Products protected by pat...
  • Trametinib

    Product Trametinib

    Trametinib

    DMSO solvate

    Oncology

    OEB 5


    Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or mad...

Polpharma S.A. Resources (7)

  • News CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

    This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 
  • Brochure API Product List 2024

    We manufacture our products by following our customers' and health authorities' most stringent requirements. 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.
  • News KiloLab Laboratory: strategic milestone achieved!

    KiloLab Laboratory – a development and production in a kilogram scale – has been launched, according to Polpharma API development strategy adopted in 2021.
  • Whitepaper Safe approach in delivering nitrosamine-free API products

    In July 2018, the pharmaceutical industry was shaken when nitrosamine impurities were detected in human medicines, leading to recalls of several batches of high blood pressure and heart failure med valsartan. Investigations by health authorities and drug companies revealed that nitrosamines are generated during the synthesis of active pharmaceutical ingredients (APIs). Read our safe approach in delivering nitrosamine-free at Polpharma API products.

    Karina Boszko, head of API Regulatory Affairs and Customer Technical Support Department, explains how we at Polpharma undertake this challenge.


    The full article available: https://www.api.polpharma.com/news/safe-approach-in-delivering-nitrosamine-free-api-products/
  • Whitepaper POLPHARMA API: Why particles size is important in pharmaceutical industry and how to get the required particle size?

    In the pharmaceutical industry, particle size has become one of the key aspects inthe development of the active pharmaceutical ingredients (APIs) and qualitycontrol of solid oral dosage forms. The physicochemical and biopharmaceutical properties of biologically active substance can be highlyaffected by crystal size and its distribution (CSD), also called as particle size distribution (PSD). According to thelatest scientific reports, it is estimated that almost 80% of new promising molecules having biological activity are rejected during the research and development process due to the low water solubility what is strongly related tothe bioavailability and release of the drug. Polpharma API has many years of experience in delivering APIs with the right particles size distribution through crystallization, milling/micronization, vibration sieving or other technologies. Learn more from our experts!
  • Video POLPHARMA API: TECHNOLOGY EXPANSION & STRATEGIC DIRECTION

    Recent investments in Polpharma API’ capabilities will support a strategic move into complex API development and manufacturing for CDMO partners and generics companies worldwide, empowering the global supply chain.Visit us and learn how Polpharma API enters into a strategic transformation process that aims to invest in new capabilities and technologies like high containment or cryogenic to be fully implemented by 2026. However, our production capacity will increase significantly already from mid-2023!

    Would like to meet our representatives and learn more, please contact us today: [email protected][email protected]
  • Video How can we grow business value together?

    Check out how we can create business value together in the whole pharmaceutical value chain, including API, B2B, commercial partnerships and other forms of collaboration. In the video: Markus Sieger, CEO of Polpharma Group, David Gonzalez, Commercial Director of API Business Unit, Mieczyslaw Starkowicz, Head of B2B Venture and Simon Clark, Commercial Director for Polpharma Group and strategic partners.