Pharmanutra obtains FDA registration for its Pisa manufacturing facility

The U.S. Food and Drug Administration registration strengthens the Group’s manufacturing capabilities and regulatory framework for the U.S. market.

Pharmanutra S.p.A. has obtained official registration with the U.S. Food and Drug Administration (FDA) for its manufacturing facility located at Via Campodavela 1, Pisa, Italy.

The registration formally identifies the site as a facility authorized to manufacture food substances —with particular reference to the functional principles based on Sucrosomial® Technology — intended for the production of dietary supplements for the U.S. market, in accordance with the applicable regulatory framework.

This milestone represents a strategic step in the Group’s international growth path and further strengthens Pharmanutra’s ability to operate within one of the most structured and demanding regulatory environments worldwide.

Thanks to this registration, Pharmanutra will be able to:

• internally manage the production of patented blends intended for the U.S. market
• ensure compliance with the requirements of the Federal Food, Drug and Cosmetic Act, as amended by the Bioterrorism Act
• further strengthen its internal manufacturing supply chain, maintaining direct control over processes and quality standards

Obtaining FDA registration represents an additional step in reinforcing the Group’s regulatory and manufacturing infrastructure, in line with Pharmanutra’s international growth strategy.

The Regulatory Affairs and Quality departments, coordinating the activities required to meet U.S. regulatory requirements, is completing the final procedural adjustments to ensure the facility’s full operational alignment with FDA requirements.

This achievement confirms the Group’s ongoing commitment to maintaining high standards of quality, safety and regulatory compliance — key elements supporting Pharmanutra’s development in major international markets.