Biocon’s Manufacturing Facility In Malaysia Receives Establishment EIR From USFDA

Biocon Ltd on Wednesday said its insulin manufacturing facility in Malaysia has received Establishment Inspection Report (EIR) from the US health regulator with a ‘Voluntary Action Indicated’ classification. In a regulatory filing the company said, Biocon Sdn Bhd, a subsidiary of Biocon Ltd has received the EIR from the USFDA for the Pre-Approval Inspection (PAI) of its insulin manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between February 10 and February 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 February 2020,” Biocon added. According to the US health regulator, a VAI classification “means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action”. “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,” a company spokesperson said. Further, the “Insulin Glargine (Semglee) application filed by our partner Mylan, with the USFDA under the 505(b)(2) NDA pathway, is currently under review.” the spokesperson added

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