Polpharma's HP API facility

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

The strong voice of Polpharma Group in Europe

Our recent investment in HP API is an essential milestone in building new capabilities and competencies to secure the European supply chain.

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.

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.

• 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

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

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

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

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.

For Polpharma API the future begins today…

Learn more: https://www.api.polpharma.com/