Emphasis on Quality

Huvepharma® Italia emphasizes quality assurance throughout the entire cycle of production, distribution and use. The Quality Control department executes strict quality control of all incoming materials, critical steps during manufactures (IPCs), intermediates and finished products an accordance with the approved specifications.

Production steps and processes are carried out in accordance with the GMP, following detailed standard operating procedures and detailed written records are created and kept for each production batch. The management oversees an ongoing training program for the continuous improvement of the qualification of both employees and management.

Our regulatory team is experience in dealing with DMF preparation (CTD format), CEPs and dossiers necessary for submissions in Italy, Europe, US, Japan and WHO.

In-depth attention to the quality results in the followings active certification:

  • GMP certificate and manufacturing license issued by the Italian authority (AIFA)
  • US –FDA approval for some of the products intended for the US market.
  • CEPs for some of the APIs
  • WHO prequalification for anti-malaria APIs and GMP intermediates
  • Japan PMDA accreditation