Biocon gets USFDA observations

Geyatee Deshpande
/ Categories: Trending, DSIJ News
Biocon gets USFDA observations

Biocon has been issued 12 observations by the USFDA for its assembly facilities in Malaysia. Despite the news, the stock price of the company increased by 1.5 per cent.

A pre-approval inspection across three units of Biocon Sdn Bhd's insulin glargine drug substance, drug product and device assembly facilities concluded with 12 observations by issuing an FDA Form 483. An FDA Form 483 is issued when the investigator has observed conditions which violate the Food Drug and Cosmetic (FD&C) Act and related Acts. The inspection took place between June 24 and July 5, 2019. The company officials responded by saying that corrective and preventive actions will be taken accordingly and there will not be any change in the commercialisation plans for insulin glargine in the US.

Biocon Ltd. is a Bangalore headquartered biopharmaceutical company manufacturing generic active pharmaceutical ingredients(APIs), bio-similar insulins and antibodies. The company‚Äôs subsidiary Syngene International Limited (Syngene) has business operations in integrated end-to-end drug discovery and development services.

On Monday, the stock of the company was trading at Rs. 243.35, an increase of 1.5 per cent or Rs. 3.6 per share. The 52-week high was Rs. 359.18 and 52-week low was Rs. 230 on the BSE.

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