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Biocon receives EIR from USFDA for good manufacturing practice inspection

"We remain committed to global standards of quality and compliance," company spokesperson said

Press Trust of India  |  New Delhi 

Biocon
Employees of Biocon Ltd work inside the company's research and development centre in Bengaluru. File photo: Reuters

on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good manufacturing practice (GMP) inspection of its small molecules manufacturing facility in Bengaluru.

"The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, the company spokesperson said in a filing to BSE.

"has received the EIR from the (FDA) for the post-approval and GMP inspection of its small molecules active pharmaceutical ingredient (API) manufacturing facility at 20th KM, Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020," as per the filing.

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At the conclusion of the inspection last month, the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company, the filing said.

"We remain committed to global standards of quality and compliance," company spokesperson added.

The shares of Biocon were trading at Rs 257.00 apiece on the BSE, up 1.76 from the previous close.

First Published: Fri, March 20 2020. 11:47 IST
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