The FDA awards IBSA: standard excellence confirmed10 February 2020
The Food and Drug Administration, the authority that approves the marketing of drugs in the United States of America, has once again recognised the very high quality standards of IBSA products. After a very thorough audit involving various departments of both the Italian branch and the headquarters in Switzerland, the agency has reconfirmed the approval for sale in the USA of a sterile injectable medical device, in syringe vials, produced by IBSA. This major recognition further highlights our commitment to achieving the highest standards of drug quality and efficacy and maximum safety for patients.
The audit verified the experience and professionalism of the operators involved in the process, the suitability of technical facilities and the comprehensiveness of the company’s Quality System covering and managing all the organisational aspects of production. IBSA passed each check with flying colours.
The pharmaceutical industry's current context is extremely competitive, demanding and selective at all levels, both in Europe and outside of Europe. There is a constant increase in ever more stringent, specific and restrictive regulations. This imposes upon the entire pharmaceutical sector the need for constant growth, through continuous development of very sophisticated technical advancements which require costly investments as well as increasingly complex skills on the part of operators.
The ability to compete in this scenario and to face future challenges with expertise and strength are key factors to allow pharmaceutical companies to get a footing in their target markets and provide patients with increasingly effective and curative treatments.