"We remain committed to global standards of quality and
compliance," company spokesperson said.
Biocon
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.
"Biocon has
received the EIR from the US Food and Drug Administration (FDA) for the
post-approval and GMP inspection of its small molecules active pharmaceutical
ingredient (API) manufacturing facility at 20th KM, Biocon Campus, Bengaluru,
conducted between Feb 20 and Feb 26, 2020," as per the filing.
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.
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