Fluticasone propionate process validation campaign was carried out during 2002, at Hovione Loures site and the Drug Master File was filed with the FDA in December 2002 (DMF number assigned 16334). Additionally it has also been submitted in EDQM (2006, CEP number assigned R0-CEP 2005-160-Rev00) and TPD (2003).

Hovione has filings with every world Health Authority that has a DMF system. The Regulatory Group is able to prepare data for an IND, NDA, ANDA, VMF or DMF to be filed at relevant Health Authorities.

The Regulatory group works closely with R&D, Manufacturing, Quality Control and Quality Assurance to coordinate work requirements from the submission point of view.