Last Updated : Wednesday, April 1, 2020 20:03:16

USFDA inspects Biocon’s Malaysian facility, issues EIR with VAI classification

BANGALORE / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bengaluru headquartered Indian bio-technology company Biocon Ltd said of having got Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAI) for the company’s Malaysian facility, engaged in manufacturing insulin.

The company statement attributed to the company spokesperson, titled, “Company Statement – Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from U.S. FDA with Voluntary Action Indicated (VAI) Classification, Inspection Stands Closed”, enclosed with the regulatory filing as submitted to the Indian Bourses, further read that, Biocon Sdn Bhd, a subsidiary of Biocon Limited (BSE code: 532523, NSE: BIOCON) 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.

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.

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