Polpharma SA

Exhibitor at CPHI Barcelona 2023 stand 5H49, Integrated Pharma
About Us

Polpharma Group is a high quality European pharma manufacturer and a reputable business partner for companies worldwide at every stage of product development, manufacturing & commercialization (FDF, API, CDMO, CMO).

Polpharma API 
is a Poland-based CDMO of APIs, and significant European API producer, delivering products to more than 65 countries on 6 continents. We run with $45-million manufacturing expansion to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities.

  • PL
  • 2015
    On CPHI since
  • 3
  • 5000+
Company types
Contract Service
Generics/Biosimilars Manufacturer
Pharmaceutical company
Contact info
Event information
CPHI Barcelona 2023
  • 24-26 October 2023
  • Fira Barcelona Gran Via, Spain
  • Visit us at stand 5H49, Integrated Pharma

Products Featured at CPHI Barcelona 2023

  • Ticagrelor

    Product Ticagrelor


    The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP...
  • Baclofen

    Product Baclofen

    Therapeutical Area: Musculo-skeletal system • EU DMF available • US DMF no. 18014 available • Japanese DMF available • CEP available
    Indication: Baclofen is primarily used for the treatment of spastic movement disorders and alcoholism.

  • Risedronate sodium

    Product Risedronate sodium

    Therapeutic Area: Musculo-skeletal system • EU DMF available • US DMF no. 20384 available • Japanese DMF available • CEP available

    Indication: Risedronate sodium is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism.

  • Hydrochlorothiazide

    Product 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' ability to retain water. This reduces the volum...
  • Tadalafil

    Product Tadalafil

    Therapeutic area: genito-urinary system & sex hormones

    EU DMF available

    US DMF : 24590

    CEP available

  • Alendronate sodium

    Product Alendronate sodium

    Therapeutic Area: Musculo-skeletal system • EU DMF available • US DMF no. 16962 available • Japanese DMF available • CEP available

    Indication: Alendronate sodium is a bisphosphonate drug used for osteoporosis and several other bone diseasesMusculo-skeletal diseases

  • Acenocoumarol

    Product Acenocoumarol

    Therapeutic Area: Cardiovascular systemEU DMF available Indication: Acenocoumarol is an anticoagulant that functions as a vitamin K antagonist
  • Acetazolamide

    Product Acetazolamide

    Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 10383 available • CEP available Available also in injectable form
    Indication: Acetazolamide decreases the pressure in the eye and is used for adjunctive treatment of glaucoma, a condition in which increased pressure ...
  • Aripiprazole

    Product Aripiprazole

    Therapeutic Area: Nervous System • EU DMF available • US DMF no. 23314 available • CEP available

    Indication: used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). It is also used together with other medications to treat major depr...
  • Carbamazepine

    Product Carbamazepine

    Therapeutic Area: Nervous System
    • EU DMF available • US DMF no. 26266 available • CEP available Indication: Carbamazepine is an anticonvulsant and mood-stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder, as well as trigeminal neuralgia.

  • Carvedilol

    Product Carvedilol

    Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 17060 available • CEP available
    Indication: Carvedilol is a carbazole derivative acts as anti-hypertensive agent. It is formulated as tablets for oral route of administration. Carvedilol is indicated for the management of e...
  • Clopamide

    Product Clopamide

    Therapeutic Area: Cardiovascular system • EU DMF available
    Indication: Clopamide is indicated for the treatment of oedema, hypertension. It is formulated as tablet for oral administration. It is categorised as a thiazide like drug and works in similar way as the thiazide diuretics. It acts at the p...
  • Carvedilol phosphate hemihydrate

    Product Carvedilol phosphate hemihydrate

    Therapeutic area: Cardiovascular system • EU DMF available • US DMF no. 20633 available 
  • Etodolac

    Product Etodolac

    Therapeutic Area: Musculo-skeletal system • EU DMF available • US DMF no. 11405 available • Japanese DMF available • CEP available

    Indication: Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of mild to moderate pain, fever, and inflammation.

  • Ibandronate Sodium

    Product Ibandronate Sodium

    Therapeutic Area: Musculo-skeletal system • EU DMF available • US DMF no. 25638 available • Chinese DMF - under registration

    Indication: Ibradronic Sodium is a potent bisphosphonate drug used in the prevention and treatment of osteoporosis

Polpharma S.A. Resources (10)

  • Brochure API Product list & Developed API

    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.
  • Brochure High Potent API Pipeline

    We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024 with full completion scheduled for Q3 2024.
  • Brochure Polpharma & Farmaprojects FDF Dossier List

    We offer an attractive portfolio of FDF focused on the newest and most prescribed therapies, having a customer centric approach through a multidisciplinary support team: Sales, Marketing, R&D, RA, QA&QC, IP, etc. Due to combined efforts of Polpharma and its strategic partner Farmaprojects we guarantee supply continuity in EU and non-EU territories.
  • Brochure Polpharma API CDMO offer

    Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.
  • 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!

    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.
  • Video Strategic investment HP API facility

    In 2022, we are opening a new chapter in the history of Polpharma in the field of ​​active substances. With the strategic investment in a HPAPI facility, Polpharma and Poland are becoming a strong pillar of the European pharmaceutical industry in the coming decades.

    You can read a full article: https://www.api.polpharma.com/news/polpharmas-strategic-investment-in-hpapi-facility-the-first-of-this-kind-in-poland/