Glenmark Pharma takes a beating on USFDA warning to North Carolina facility

Shares of Glenmark Pharmceuticals fell 2 percent in early trade on June 22, a day after the US Food and Drug Administration issued a warning letter to the drugmaker’s the Monroe facility in the US.

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

The pharma major, however, sees no threat to its business. “The company had done a voluntary recall of all its products from this site in August 2021 and since then has not been commercialising any product from this site,” it said in a filing with the exchanges. “Hence, the warning letter will have no impact on the existing revenues.”

At 9.51am, shares of Glenmark Pharmaceuticals were trading at Rs 635.15 on the NSE, down 1.2 percent from the previous close.

Follow our live blog for all the market action

Last week, Glenmark had also substantially reduced the cost of its version of trastuzumab, a drug used in the treatment of breast cancer. The drug, marketed as Trumab, will now be accessible to patients at a price 30-40 percent lower compared to the prevailing market rates. Glenmark’s trastuzumab variant will be priced at Rs 15,749 per vial.

The treatment for breast cancer typically involves 18 cycles, and considering the current pricing, the total cost of therapy could range from Rs 4 to 5 lakh. Consequently, Glenmark’s price cut will bring the total expense for 18 cycles of treatment to slightly less than Rs 3 lakh.