Biocon gets USFDA EIR with VAI Classification for its Malaysian Insulin Manufacturing Facility
Bengaluru: Biocon Sdn Bhd, a subsidiary of Biocon Limited has announced that it has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) of its Insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between Feb 10 and Feb 21, 2020.
"The Inspection has been closed with a "VAI" (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Feb 2020. This is an endorsement of our commitment to global standards of Quality and Compliance, "Company Spokesperson added
"The closing of the USFDA Inspection of our Malaysia Facility is an important milestone in our journey of developing Insulin Glargine for patients in the US. Our Insulin Glargine (Semglee®) application filed by our partner Mylan, with the USFDA under the 505(b)(2) NDA pathway, is currently under review, "Company Spokesperson further added
Biocon Limited is an Indian biopharmaceutical company based in Bangalore, India. The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe.
It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets. In research services, Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon.