Glenmark Pharma Aurangabad unit clears FDA test – CNBC TV18

Glenmark Pharma Aurangabad unit clears FDA test – CNBC TV18

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Drug firm Glenmark Pharmaceuticals Ltd on Friday (September 20) said its formulation manufacturing facility in Chhatrapati Sambhaji Nagar (Aurangabad), has successfully completed a routine inspection by the US Food and Drug Administration (FDA).

“This is to inform you that the U.S. FDA has issued Form 483 with zero observations after an inspection at the company’s formulation manufacturing facility based out of Chhatrapati Sambhaji Nagar (Aurangabad), India between September 09 and September 20, 2024,” the company said in a stock exchange filing.

The inspection, conducted between September 9-20, 2024, concluded with the issuance of a Form 483, recording zero observations.

Also Read: Glenmark Pharma to pay $25 million over five years to settle US investigations

Glenmark Pharmaceuticals reported over two-fold increase in consolidated net profit to ₹340.2 crore for the first quarter that ended June 30, 2024. In the corresponding quarter, Glenmark Pharmaceuticals posted a net profit of ₹37.7 crore.

The company reported consolidated profit before exceptional items and taxes of ₹462 crore ($55 million) for the quarter ended June 30, from ₹203 crore a year ago. The company had a one-time charge of ₹52.02 crore in the year-ago period for repairs at its manufacturing facilities in India and the United States.

Glemmark’s revenue from operations increased 6.9% to ₹3,244.2 crore against ₹3,036 crore in the corresponding period of the preceding fiscal. At the operating level, EBITDA jumped 34.5% to ₹588.3 crore in the first quarter of this fiscal over ₹437.3 crore in the year-ago period.

Also Read: Glenmark Pharma gains after subsidiary launches eye allergy drug in US

Shares of Glenmark Pharmaceuticals Ltd ended at ₹1,635, down by ₹16.15, or 0.98%, on the BSE.

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