Avrio Receives Drug Manufacturing License and Medical Device Manufacturing License from the California Food and Drug Branch
DATE OF RELEASE
February 10, 2010
IRVINE, CA - Avrio Biopharmaceuticals, LLC, a wholly-owned subsidiary of Irvine Pharmaceutical Services, Inc., received approval to manufacture and ship pharmaceutical products by the California Department of Public Health, Food and Drug Branch (Cal FDB), completing the organization's portfolio of product development services in support of its pharmaceutical, biopharmaceutical, and medical device clients.
Avrio's newly built, 20,000 square foot, state-of-the-art, aseptic fill-and-finish facility includes three aseptic suites and five production suites with each suite having its own dedicated air handling system. With great confidence in the newly built infrastructure, strategic manufacturing-process flow, state-of-the-art equipment, and experienced staff, Avrio boasts its level of quality by offering clients live video viewing of production (along with on-site viewing access). In addition to a production area designed to provide clients flexibility and scalability, Avrio also includes laboratory space for quality control, microbiology, formulation, and a pilot suite. Furthermore, Avrio's affiliate, Irvine Pharmaceutical Services, Inc., located just across the street, has over 65,000 square feet of laboratory space which provides complete cGMP analytical CMC support.
With multiple manufacturing contracts in place and a number of agreements underway, Avrio has continued to value the core principles of its affiliate, Irvine Pharmaceutical Services. "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" said Assad J. Kazeminy, CEO and Founder of Irvine Pharmaceutical Services. "With the addition of Avrio, we can now support our clients from start to finish via a seamless partnership."
You can learn more about Avrio and the executive team at the upcoming 2010 PDA Annual Meeting, booth 714.
About Avrio Biopharmaceuticals, LLC
Avrio Biopharma, an affiliate of Irvine Pharmaceutical Services, is a premier contract development and manufacturing organization providing support to the pharmaceutical, biopharmaceutical, and medical device industries. Avrio, along with its Irvine affiliate, offers full cGMP product development support, specializing in preformulation/formulation, analytical development, process validation, scale-up studies, packaging and labeling, stability storage and complete analytical CMC testing. Learn more at www.avriobiopharma.com or call 866-98-AVRIO (866-982-8746).
Irvine, California 92618
T: (866) 98-AVRIO (28746)
F: (949) 462-0821
Irvine Pharmaceutical Services
Irvine, California 92618
T: (877) 445-6554
F: (949) 951-4909