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USFDA Issues a Warning Letter to Glenmark’s North Carolina Firm

Glenmark Pharmaceuticals shares were trading at Rs 635.15 on the NSE, down 1.2% from the previous close.

On June 22, Glenmark Pharmaceuticals shares fell 2% in early trade, a day after the US Food and Drug Administration (USFDA) issued a warning letter to the drugmaker’s Monroe facility in the US.


Glenmark was given the Official Action Indicated (OAI) status for its Monroe facility in North Carolina after the USFDA’s April 4-May 19, 2022 inspection.

At 9:51 am, Glenmark Pharmaceuticals shares were trading at Rs 635.15 on the NSE, down 1.2% from the previous close.

Last week, Glenmark also reduced the cost of its version of trastuzumab, a drug used for breast cancer treatment. The drug, Trumab, will now be open to patients at a price 30-40% lower than the usual market rates. Glenmark’s trastuzumab variant will be assessed at Rs 15,749 per vial.


The treatment for breast cancer classically involves 18 cycles, and seeing the current price, the overall cost of therapy could range from Rs 4 to 5 lakh. Thus, Glenmark’s price cut will bring the entire expense for 18 treatment cycles to slightly less than Rs 3 lakh.

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