Biocon’s Bengaluru facility gets 4 USFDA observations

30 Sep 2024 , 03:23 PM

Biotech business Biocon reported on September 28 that the United States Food and Drug Administration (US FDA) has completed a surveillance examination of its Active Pharmaceutical Ingredient (API) plant in Bengaluru.

The inspection, which took place between September 23 and September 27, 2024, yielded four observations from the regulatory organisation.

“Biocon has not released the specifics of the findings, but in an exchange filing, the business stated that it would resolve the mentioned observations within the timeframe specified. The Company does not foresee any impact on the business,” according to Biocon.

This inspection was part of the US FDA’s routine assessments to guarantee regulatory compliance in pharmaceutical manufacture.

On Thursday, September 26, Biocon stated that it had signed a licensing and supply deal with Astra Industrial Group’s subsidiary Tabuk Pharmaceutical Manufacturing Company. Under the agreement, the company will market its glucagon-like peptide-1 (GLP-1) products in the Middle East.

Biocon Ltd. is an integrated biotechnology company that produces biopharmaceuticals, enzymes, bespoke research, and clinical research. Statins, immunosuppressants, and anti-diabetics are among the medicinal items offered by the company.

At around 1.21 PM, Biocon was trading 1.36% lower at ₹363.85, against the previous close of ₹368.85 on NSE. The counter touched an intraday high and low of ₹369.20, and ₹361.15, respectively.

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