Polpharma API CDMO offer

Polpharma’s strategic investment in HPAPI facility, the first of this kind in Poland and one of the most advanced in Central Easter Europe.

Polpharma API is 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.

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! 

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 mid-2023 with full completion scheduled for Q1 2024.

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.

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/

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]

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.

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/