Galena Pharma Achieves MDR Certification for Entire Macrogol Range – Now 14 MDR-Certified Products in Our Portfolio

Tablets on a production line, moving along parallel tracks.

17.02.2026

Two product boxes labeled

The Medical Device Regulation (MDR) ensures the safety, quality, and traceability of medical devices across the EU. Macrogol products are intended for the treatment of constipation and have long been part of Galena’s gastrointestinal portfolio.

 

This certification marks the 14th MDR approval for Galena Pharma, demonstrating our commitment to excellence. Guided by our principle “Big in expertise, agile in action,” we combine deep regulatory know-how with flexibility to meet market needs quickly and effectively.


Galena Pharma proudly offers a wide portfolio of MDR-certified medical devices, ready for market and available for in-licensing as private or white label solutions. These products ensure compliance, safety, and quality, giving our partners a fast and reliable way to expand their offering. As a legal manufacturer, we also provide comprehensive CDMO services – from development to production – tailored to meet your specific needs.


Learn more about the products and partnership opportunities:
https://www.galena.fi/white-label-products/gastrointestinal/macrogol

Galena Pharma is a GMP- and EU MDR -certified pharmaceutical company specializing in manufacturing and developing substance-based medical devices. Galena Pharma provides its own ready-to-market MDR-approved medical devices for in-licensing as private label products. Our focus indication areas are gastrointestinal, female intimate care, cough & cold, pain and skin care.