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.
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@Bioconlimited
#Biocon's USFDA Inspection of its small molecule API facility held in Feb 2020, stands closed with EIR classifying two observations as VAI. Company is addressing these procedural observations. http://bit.ly/PR200320
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9:03 AM - Mar 20, 2020
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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.
"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.
ALSO READ: Biocon partner's Cancer drug licence application gets USFDA approval
Biocon
✔
@Bioconlimited
#Biocon's USFDA Inspection of its small molecule API facility held in Feb 2020, stands closed with EIR classifying two observations as VAI. Company is addressing these procedural observations. http://bit.ly/PR200320
View image on Twitter
6
9:03 AM - Mar 20, 2020
Twitter Ads info and privacy
See Biocon's other Tweets
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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