AUTHORIZATION

1. The production site has been approved by the Italian Drug Agency (AIFA), ) and the Food and Drug Administration (FDA) and is cGMP certified for:

  • Manufacturing and primary packaging of impregnated-matrix medicated plasters
  • Secondary packaging and pharmaceutical warehousing
  • Production of medicated plasters for clinical trials
  • Import and release on documentary basis for the European market of medicinal specialities produced outside Europe, for all pharmaceutical dosage forms

2. Authorisation for the production of Hyaluronic Acid by fermentation

3. Production of Medical Devices

Altergon Italia is a Member of:

Member of AFI Member of ISPE Member of GAMP Member of PDA

CERTIFICATION

Altergon Italia’s primary objectives concern customer satisfaction, protection of the environment and the health and safety of its personnel. In fact, the company has adopted an Integrated Environmental and Safety Quality Management System in compliance with UNI EN ISO 9001:2015, UNI EN ISO 14001:2015, UNI EN ISO 13485:2016  and UNI EN ISO 45001:2018.

View Policy Integrated Quality, Environment and Safety.

We are certified:

by the "Bureau Veritas" for the following standards

by the Customs Agency AEO IT AEOC 13 0743

The certificate is released to those demonstrating compliancy with customs obligations, accounting system criteria and financial solvency as well as responding to adequate security norms. The advantages resulting from the AEO Certification are the speed up in the implementation of customs formalities, the almost total reduction of inspections, security zone facilities, better relations with customs authorities and the mutual recognition agreement with other secure and trustworthy programs of third countries