ZF Polpharma SA

About ZF Polpharma SA

Polpharma Group is a high quality European pharma manufacturer and a reputable business partner for pharmaceutical companies worldwide. We grow our presence through B2B activities, including API development and manufacturing in our FDA-approved facility, out-licensing of vertically integrated solutions from API to finished formulation, and contract manufacturing services covering a wide variety of solid and liquid forms. With a broad experience in products’ development, manufacturing and marketing, dedicated R&D, Regulatory and Project Management resources, supported by corporate quality system and service excellence, we deliver tailored solutions to meet your business needs.

Polpharma API CDMO supports emerging and large pharmaceutical customers in 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. We provide our clients with a broad range of services across all the value chain thanks to our state of the art facilities (R&D, pilot, manufacturing and QC) and long experience in development and manufacturing highly complex active pharmaceutical ingredients.

Polpharma API is a significant European producer of Active Pharmaceutical Ingredients delivering products to pharmaceutical companies worldwide. We are present on 6 continents, in 60+ countries. 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 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.&am...

Certifications

ZF Polpharma SA

  • PL
  • 2015
    On CPhI since
  • 3
    Certificates
  • 5000+
    Employees
Meet us at

CPhI Worldwide 2021

Fiera Milano, Milan, Italy
9-11 November 2021

CPhI & PMEC China 2021

SNIEC, Shanghai, China
16 - 18 December 2021

Products from ZF Polpharma SA

  • Ticagrelor

    Product Ticagrelor

    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 made available in Germany or in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s). 

  • 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 volume of the blood, decreasing blood return to the heart and thus cardiac output and, by other mechanisms, is believed to lower peripheral vascular resistance


  • 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 in the eye can lead to gradual loss of vision (chronic simple /open-angle/ glaucoma, secondary glaucoma, and preoperatively acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide is also used to reduce the severity and duration of symptoms (upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue) of altitude (mountain) sickness. Acetazolamide is used with other medicines to reduce edema (excess fluid retention) and to help control seizures in certain types of epilepsy.


  • 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 depressive disorder in adults.
    Aripirazole is also used to treat irritability and symptoms of aggression, mood swings, temper tantrums, and self-injury related to autistic disorder in children who are at least 6 years old.


  • Avanafil

    Product Avanafil

    Therapeutic Area: Genito-urinary system & sex hormones 
    • EU DMF available
    • US DMF no. 29689 available


    Indication: Avanafil is a vasodilator. It is formulated as tablets for oral route of administration. It is indicated to treat erectile dysfunction.It is indicated for the treatment of erectile dysfunction should be used approximately 15 minutes before sexual activity. 


  • 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 essential hypertension. It is also indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction. Is also indicated for the treatment of tachycardiac atrial fibrillation.

ZF Polpharma SA Resources

  • News 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. 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! 
  • Whitepaper 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!
  • Brochure Polpharma API Commercial Products

    Polpharma API is a European CDMO Partner and API Manufacturer since 1951, Facilities for the production of APIs undergo rigorous inspections from the U.S. Food and Drug Administration (FDA). Our multipurpose plant passed FDA inspections with no observations on the Form 483 in 2004, 2009, 2012, 2015 and, most recently, in May 2018. This is something we are proud of and confirms the highest quality standards of Polpharma. Our team of highly educated experts assures that the quality of our products is maintained at all stages of the production process. Strict compliance with cGMP procedures, well documented SOPs, and a modern quality control laboratory ensure that APIs produced by POLPHARMA are of the highest quality.
  • Brochure Polpharma API Pipeline

    Development and commercialization of new, attractive APIs is the priority of the POLPHARMA API R&D Department. The key to our success is the combination of experience and expertise of our own research team as well as effective co-operation with scientific institutions.
  • 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 Polpharma API. European CDMO Partner and API Manufacturer since 1951

    Polpharma API is a European CDMO partner and API manufacturer supporting 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.
    R&D laboratories:
    - Process chemistry, from full development to transfer to production - Analytical methods transfer, development, validation
    - Second generation process for cost control
    FDA approved GMP facilities from pilot plant scale to multi-ton manufacturing scale Security of supply assured by network of well-established partners or back integration of intermediates and starting materials State of the art QC laboratories for product release
  • 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 Commercial & Pipeline List

    Polpharma API has been trusted for over 80 years for its commitment to quality. Our well-balanced and expanding portfolio, along with our scientific know-how and experience, allow us to offer attractive solutions for drug developers around the globe. Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities from Europe, US, Japan, Korea, Brasil and many others. We invite you to work with us!
  • 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 How can we grow business value together?

    Check our how we can create business value together in the whole pharmaceutical value chain, including API, B2B, commercial partnerships and other forms of collaboration.