India's Biocon gains EIR from FDA for Malaysia insulin facility

2 April 2020

After contending with quality issues at its new Malaysia plant for several years, Indian biotech Biocon (BSE: 532523) appears to be closer to getting its insulin glargine (Semglee) product onto the US market.

On the announcement yesterday, Biocon’s shares rose 5% to 285 rupees after the company’s insulin manufacturing facility In Malaysia received the Establishment Inspection Report (EIR) from the US Food and Drug Administration for the pre-approval inspection (PAI) of its insulin manufacturing facility in Malaysia, for insulin glargine,” the company said in a regulatory filing.

The inspection was conducted between February 10 and February 21, 2020, it noted. The company further said, the Inspection has been closed with a voluntary action indicated (VAI) classification in the EIR, for the three observations issued at the conclusion of the inspection in February.

“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 United States,” Biocon noted in a press release.

Partnered with Mylan

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