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California FDB Grants Drug Manufacturing, Medical Device Licenses To Avrio

Avrio Biopharmaceuticals (Avrio), a wholly-owned subsidiary of Irvine Pharmaceutical Services, received approval to manufacture and ship products by the California Department of Public Health, Food and Drug Branch (Cal FDB), completing the organisation's portfolio of product development services in support of its pharmaceutical, biopharmaceutical, and medical device clients.

Avrio said that its newly built, 20,000 square foot, aseptic fill-and-finish facility includes three aseptic suites and five production suites with each suite having its own air handling system. In addition to a production area designed to provide clients flexibility and scalability, the company also includes laboratory space for quality control, microbiology, formulation, and a pilot suite.

Assad Kazeminy, CEO and Founder of Irvine Pharmaceutical Services, said: “For the past 22 years we have been dedicated to continual improvement of our systems and infrastructures in order to better serve the needs of our clients. With the addition of Avrio, we can support our clients from start to finish via a seamless partnership.”

Avrio is a contract development and manufacturing organisation providing support to the pharmaceutical, biopharmaceutical, and medical device industries. The company along with its Irvine affiliate, offers full cGMP product development support, specialising in preformulation/formulation, analytical development, process validation, scale-up studies, packaging and labeling, stability storage and complete analytical CMC testing.