Biocon gains 5% as manufacturing unit in Malaysia gets EIR from USFDA

Biocon Sdn Bhd, a subsidiary of Biocon, received the EIR from the USFDA for the pre-approval inspection of its insulin manufacturing facility in Malaysia, for insulin glargine

Shares of Biocon jumped 5 per cent to Rs 285 on the BSE on Wednesday intra-day after the company’s insulin manufacturing facility In Malaysia received the Establishment Inspection Report (EIR) from the US health regulator.

“Biocon Sdn Bhd, a subsidiary of Biocon has received the EIR from the US Food and Drug Administration (USFDA) 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 said.

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 Feb 2020.

The closing of the USFDA Inspection of Malaysia facility is an important milestone in the company’s journey of developing insulin glargine for patients in the US. The insulin glargine (Semglee) application filed by the company’s partner Mylan, with the USFDA pathway, is currently under review, it said.

At 10:09 am, the stock had partially erased its gains and was trading 3 per cent higher at Rs 279 on the BSE, as compared to 2.4 per cent decline in the S&P BSE Sensex. A combined 1.9 million shares have changed hands on the counter on the NSE and BSE so far.