Polpharma S.A.
About Polpharma S.A.
Certifications
Categories
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PL
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2015On CPHI since
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4Certificates
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5000+Employees
Company types
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)
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Product Ticagrelor
Ticagrelor
form II
Own process patent to free from nitrosamines
CEP,
US DMF,
EU DMF,
Korean DMF,
Canadian DMF,
Cadifa -
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... -
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... -
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... -
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... -
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 ... -
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... -
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... -
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... -
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... -
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... -
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)
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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.
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