Philogen S.p.A. announces receipt of the Good Manufacturing Practice Certificate for its new Production facility in Rosia (Siena, Italy) by Competent Authorities
The certification was granted by the GMP MED office of the Agenzia Italiana del Farmaco (AIFA) following an inspection occurred in July 2023.
- The certification was granted by the GMP MED office of the Agenzia Italiana del Farmaco (AIFA) following an inspection occurred in July 2023.
- AIFA confirmed that Philogen new facility complies with the requirements and guidelines of Good Manufacturing Practice outlined in the Directive 2003/94/EC issued by the European Parliament.
- In the European Union, national competent authorities - AIFA in Italy - are responsible for inspecting manufacturing sites based within their own territories.
- The Rosia facility will manufacture commercial supplies of Nidlegy™ and has been structured to address a global distribution of the product.