Glenmark Pharma faces USFDA warning, impacting North Carolina Facility

Glenmark receives USFDA approval for Generic Diabetes Drug

Glenmark Pharma faces USFDA warning, impacting North Carolina Facility

Glenmark Pharmaceuticals witnessed a 2% decline in its shares during early trade on June 22, following the issuance of a warning letter by the US Food and Drug Administration (USFDA) to its Monroe facility located in North Carolina.

The USFDA conducted an inspection of Glenmark’s Monroe facility between April 4 and May 19, 2022, which resulted in the facility being designated as Official Action Indicated (OAI).

Despite this development, Glenmark remains confident about its business prospects. In a filing with the exchanges, the company stated that it had voluntarily recalled all products from the facility in August 2021 and has not commercialized any products from there since. Therefore, the warning letter is not expected to impact the company’s current revenues.

In a separate development last week, Glenmark significantly reduced the price of its trastuzumab, a drug used in the treatment of breast cancer. The drug, marketed as Trumab, will now be available to patients at a price that is 30-40% lower than the prevailing market rates. Glenmark’s trastuzumab variant will be priced at Rs 15,749 per vial.

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Breast cancer treatment typically involves 18 cycles, and with the current pricing, the total cost of therapy ranges between Rs 4 to 5 lakh. With Glenmark’s price reduction, the total expense for 18 cycles of treatment will be slightly below Rs 3 lakh.

About Glenmark:

Glenmark Pharma was established with the goal of becoming a prominent global pharmaceutical company that focuses on integrated research. Our branded generics division has a strong presence in various markets in emerging economies, including India.

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