Since August 2016, our Loudéac facility in France has been EXCiPACT™ certified, a recognition that covers the production and packaging of all products manufactured
within our state-of-the-art facility. This certification demonstrates our commitment to the highest quality and safety standards in the production of pharmaceutical excipients.

What is the EXCiPACT™ certification?

EXCiPACT™ is an independent certification program developed by major players in the pharmaceutical industry: IPEC (International Pharmaceutical Excipients Council), EFCG (European Fine Chemicals Group), FECC (European Association of Chemical Distributors), PQG (The Pharmaceutical Quality Group) that certifies that excipients are manufactured and distributed in accordance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements, in compliance with ISO 9001 standards. This globally recognised third-party certification system demonstrates the quality and safety of excipients throughout the supply chain, thereby reducing risks for finished pharmaceutical products and patients. 

Why is it so important for the pharmaceutical industry?

Pharmaceutical excipients play a key role in the stability, shelf life and effectiveness of medicines. Their quality and safety are therefore essential to ensure patient protection and the conformity of finished products.

EXCiPACT™ certification has become an essential international standard for manufacturers and distributors of excipients. It is also an essential resource for pharmaceutical companies, facilitating their supplier qualification processes thanks to several advantages:

• Fewer audit requirements: with a single EXCiPACT™ recognised audit, excipients are proven to comply with regulatory requirements, simplifying supplier management and
  reducing costs.
• Transparency and safety: EXCiPACT™ certification ensures that excipients meet strict quality and traceability standards, thereby enhancing transparency and safety.
• Regulatory compliance: authorities require excipient users to qualify their suppliers through GMP/GDP audits. EXCiPACT™ certification meets this requirement by providing
  independent and credible proof of supplier compliance.

A certification reflecting ARMOR PHARMA’s continuous commitment

Although EXCiPACT™ certification is not mandatory, obtaining it provides a guarantee of quality and reliability. It certifies that the production site is fully capable of manufacturing reliable excipients that comply with international standards. 

At a time when regulations and quality expectations are constantly rising, the EXCiPACT™ certification obtained by our Loudéac production site since August 2016 illustrates our unwavering commitment to high quality standards. 

This certification strengthens the confidence of our partners while ensuring patient safety. To ensure compliance, ARMOR PHARMA is subject to regular surveillance audits with a renewal audit every three years and two monitoring audits between each cycle. The next audit is scheduled for May 2026, demonstrating our ongoing commitment to excellence. 

For more information on EXCiPACT™, visit: https://www.excipact.org/