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Biocon gets 6 observations from USFDA after inspection of Bengaluru plant

Biocon is confident of addressing these expeditiously and remains committed to global standards of quality and compliance, the statement added

Biocon  |  Usfda  |  Biotechnology

Press Trust of India  |  New Delhi 

Biocon likely to channelise investments towards non-insulin biologics

major Wednesday said the US health regulator has issued six observations in Form 483 after pre-approval inspection of its drug substance manufacturing facility in Bengaluru.

The United States Food and Drug Administration (USFDA) concluded a pre-approval inspection of Biocon's drug substance manufacturing facility triggered by a New Drug Application submitted by the company's API customer, a company spokesperson said in a statement.

"The inspection at the Bengaluru facility took place between February 25-March 5, resulting in a Form 483 with six observations," it added.

is confident of addressing these expeditiously and remains committed to global standards of quality and compliance, the statement added.

The FDA Form 483 is issued to a firm's management at the conclusion of an inspection "when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."

Shares of closed at Rs 625.45 per scrip on BSE, down 0.29 per cent from its previous close.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Wed, March 06 2019. 19:40 IST