Quality-oriented

We are a pharmaceutical company licensed to produce:

• Medicinal products for human use
  Authorisation of the Italian Medicines Agency (AIFA) for the production (preparation, packaging, analyses and release) of low-volume liquids (including corticosteroids) and in the GMP facility located in Pomezia also semi-solids, lyophilisate and semi-solid homeopatic products, all produced by aseptic processing;
• Medicinal products for veterinary use
  AuAuthorisation of the Italian Ministry of Health (Office V Manufacture of Veterinary Medicinal Products) for the production (preparation, packaging, analyses and release) of low-volume liquids produced by aseptic processing.

We specialise in contract manufacturing in compliance with EudraLex, volume 4, Good Manufacturing Practice (GMP) guidelines.

The management system of all our plants (Sant’Agata Bolognese, Rovereto sul Secchia and Pomezia) complies with ISO 13485:2016 (Medical devices – Quality management system – Requirements for regulatory purposes) which allows:

• development, direct and contract production and sale of sterile and non-sterile medical devices in liquid, gel and cream form, in single-dose and multi-dose containers, in Sant’Agata Bolognese and Rovereto sul Secchia production facilities;
• design, development, production and distribution of wetting and lubricating solutions to supplement lachrymal fluids in the Pomezia GMP facility.

Indeed, we are private label medical device manufacturers as well as producers of medical devices as third parties manufacturers.

Our Rovereto sul Secchia plant operates in compliance with ISO 22716:2007 (Cosmetics Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices) which allows the contract manufacturing of cosmetics, also by aseptic processing.

The Pomezia plant manufactures products for many of the world’s most prestigious companies in the ophthalmic sector, which then distribute them worldwide. This is possible thanks to approvals that we have obtained from numerous non-European countries: each approval guarantees full compliance of the pharmaceutical products and medical devices produced by us with the regulations in force in that specific country. These are the main regulatory and certifying bodies which have approved product distribution:

• FDA – United States
  We are authorized to sell some OTC products on US market
• ANVISA - Agência Nacional de Vigilância Sanitária – Brasil
  for ophthalmic medical devices
• TGA – Therapeutic goods administration – Australia
  for Medical Devices
• TMMDA - Turkish Medicine and Medical Device Agency - Turkey
• Ministry of Health of The Republic of Belarus - Belarus
• Ministry of Industry and Trade of the Russian Federation - Russia