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Glenmark Pharma's Indore unit gets USFDA warning letter; Stock in F&O banShares of Glenmark Pharma are in F&O ban on Monday, July 14, which means no new positions can be created in the stock.By Ekta Batra   July 14, 2025, 7:55:09 AM IST (Published)2 Min ReadGlenmark Pharmaceuticals Ltd. has received a warning letter from the US Food and Drug Administration (USFDA) for its facility in Indore, Madhya Pradesh, the company said in an exchange filing on Sunday, July 13.

The US drug regulator had inspected the site from February 3 to February 14 this year, post which, the facility had received an official action indicated (OAI) status in May 2025.

Glenmark Pharma said that no data integrity observations were cited in the letter. It added that the warning letter is not expected to impact the existing revenues of the company or disrupt supplies from the facility.

In 2023, the company's Monroe facility was issued a warning letter as well. It was later re-inspected and issued five observations in June 2025.

Glenmark Pharma's Goa facility too was issued a warning letter in November 2022.

A warning letter is a serious communication from the USFDA that signifies a potential risk to public health or safety due to non-compliance with regulations.

"We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities," Glenmark rote in its exchange filing.

Last week, Glenmark Pharma's subsidiary Ichnos Glenmark Innovation (IGI), signed an exclusive licensing agreement with AbbVie for ISB-2001.

While Glenmark Pharma will retain commercialisation rights for its lead investigational asset, ISB 2001, in India and emerging markets, AbbVie will take over development and commercialisation across the US, Europe, Japan, China and other developed markets.

ISB 2001 is a tri-specific antibody against the development for multiple myeloma. It is still in Phase 1B of testing.

Shares of Glenmark Pharma are in F&O ban on Monday, July 14, which means no new positions can be created in the stock.

The stock ended the previous session 14.3% up at ₹2,175.9 apiece. It has gained 34.8% this year, so far.

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