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The FDA awards IBSA: confirmation of the excellence of our standards

10 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, the authority has reconfirmed the authorisation for sale in the USA of a sterile injectable medical device, in syringe vials, produced by IBSA.

“This recognition is very important for our company, which has always been particularly keen on meeting the highest quality requirements for its drugs, with the aim of guaranteeing maximum safety and effectiveness for patients,” says Luca Crippa, CEO and Managing Director of IBSA Farmaceutici.

The auditor who conducted the audit verified the experience and professionalism of all the operators involved in the process, the suitability of the technical facilities and the completeness of the company's Quality System covering and managing all the organisational aspects of production. All tests and checks were passed with flying colours and this fills us with pride.

The current context of the pharmaceutical industry is extremely competitive, demanding and selective at all levels, in Italy, in Europe and outside of Europe. There is also a constant increase in ever more stringent, specific and restrictive regulations. These conditions impose upon the entire pharmaceutical sector the need for constant growth, increasing and developing very sophisticated technical adaptations requiring new, ever more costly investments, as well as mastery on the part of operators of increasingly complex know-how.

“Only companies that manage to develop innovation and research and design cutting-edge products, thus keeping pace with technological development, will be able to measure themselves against the continuous challenges posed by the market. These are challenges that IBSA wants to continue to overcome”, concludes Dr Crippa.

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