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Polpharma API is a comprehensive active pharmaceutical ingredient (API) production facility certified by the US FDA, with a global reach.

As part of the Polpharma API strategy, in 2022, we began implementing a significant investment in a specialized facility for the Research, Development, and Production of highly potent active substances (HP API).

Just two years after the cornerstone was laid for the new facility's construction, we celebrated the completion of investment work under Paweł Grunt's leadership.

The new facility's opening ceremony was attended by distinguished guests, including Mr.Jerzy Starak, Markus Sieger, representatives of the Management Board of Polpharma Group, Sebastian Szymanek, representatives of the Management Board of Polpharma S.A., and Polpharma employees. However, it was the API Plant employees who constituted the most important part of this exceptional event.

We also had the pleasure of hosting our key business partners, including Mr. Paweł Przewięźlikowski, CEO of Polish biotech company Ryvu Therapeutics.

RYVU and Polpharma API combine knowledge andexperience with state-of-the-art technology, which is crucial for the CDMO strategic projects supporting innovative solutions in cancer treatment.

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The strong voice of Polpharma Group in Europe

Our investment is an essential milestone inbuilding new capabilities and competencies to secure the European supply chain.

Markus Sieger highlighted in his speech that Polpharma Group takes active part - as a member of Critical Medicines Alliance and expert of EFCG - in a creation of Critical Medicines Act which has been already announced in Ursula von der Leyen's speech on her election address to EU Parliament." He summarized, "Now, it is up to us touse this opportunity for the benefit of our business and, most importantly, inthe interest of the patient. Our HP API investment is exactly whatEurope needs to fulfill its ambition.”

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The benefits of HP API production in Europe

1. Improved Supply Chain Security: Localized HPAPI production reduces Europe's dependence, decreases lead times, and reduces the risk of shortages incritical medicines.
2. Quality and Safety: European pharmaceutical manufacturing has long been synonymous with quality. European facilities are more tightly regulated than many of their counterparts abroad, reducing the risk of contamination or substandard products entering the market.
3. Environmental Sustainability: European API production facilities must meet stringent environmental regulations, limiting pollution and waste. By reshoring, we also reduce the carbon footprint of transporting APIs across continents.
4. Economic Growth and Innovation: Reshoring API manufacturing represents a massive economic opportunity for Europe. The pharmaceutical industry is already one of Europe's most innovative sectors, contributing over €300 billion to the economy each year and being the fifth most technologically advanced sector.

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Why HP API?

In recent years, we have witnessed a remarkable transformation within the pharmaceutical landscape, particularly in the development and application of Highly Potent Active Pharmaceutical Ingredients. This shift is especially vital in the field of oncology.

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• Global spending on cancer medicine reached $223 billion in 2023 and is projected to rise to $409 billion by 2028.
• HP API market size in 2023 was 28bn USD, with the prognosis to grow up to 52bnUSD in 2030
• The increasing number of FDA approvals for oncology drugs is a positive trend and has doubled over the last ten years, from 12 in 2014 to 25 in 2023

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Polpharma HP API facility infrastructure

Process Development Laboratory

• 4x Isolators (Dispensing unit, 2x Wet units and Dry unit)
• 2x Reactor 1000ml
• 2x Reactor 250ml
• 4x Reactor 100ml
• 2x Tray Dryer

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Analytical Development Laboratory + QC

• 5x Isolators
• 12x Fume Hoods
• 5x Ventilated Enclosures
  • - HPLC with detectors: UV-Vis (PDA), RI

  • - UPLC with detectors: UV-Vis (PDA), RI, MS, FLR

  • - SFC (UPC2, Ultra-performance Supercritical Fluid Chromatography)
  • - IC                       TGA
  • - Titrators         Malvern
  • - IR, XRPD          DSC

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GMP Kilo-Lab

• OEL: ≥10 ng/m3
• Combined Isolators (Dispensing area, Wet area and Dry area)
• Reactors: 5l, 15l, 35l
• Nutshe Filter
• Mill
• Tray Dryer

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Big step for our presence in the industry

Our new HP API facility will place us at the forefront of oncology and other specialty medicine development, enabling us to address better, more targeted therapies. As Shlomo Gang emphasized in his speech, the new facility "will strengthen both pillars of the Polpharma API business model: Generic and CDMO (Contract Development and Manufacturing). This will help us drive growth and position ourselves appropriately in relation to changing market needs." In the area of ​​business development, we focus on CDMO partnerships with emerging biopharmaceutical companies, which account for as much as 60% of oncology research conducted in 2023 – summarised Shlomo.

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We were honored to host a representative of one of such companies, Mr. Paweł Przewięźlikowski, CEO of RYVU Therapeutics, who emphasized in his speech that thanks to new investments and Polpharma’s offer aimed at biotechnology companies, active substances can be purchased in Poland, choosing the optimal combination of supply chain, quality, timelines and product cost.

The RYVU CEO pointedout that Polpharma stimulates the development of the broad pharmaceutical sector in Poland in several ways, including new processes used in the production of generic drugs, contract research, biosimilars, and innovativedrugs. This is something that we, all employees of the Polpharma Group, can beproud of.

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Management Board represented by JerzyStarak and Markus Sieger expressed appreciation to all  colleagues that contributed to the start andimplementation of this ambitious project.

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For Polpharma API the future begins today…

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