Shares of Glenmark Pharma Ltd are trading flat after touching a day’s high of Rs 2,197.70 on 14th July, following the company’s disclosure that it received a warning letter from the US Food and Drug Administration (USFDA) for its facility in Indore, Madhya Pradesh, according to an exchange filing yesterday.

The USFDA inspected Glenmark Pharma’s Indore facility between 3rd and 14th February, 2025. Later, it was given an Official Action Indicated (OAI) status in May 2025. The warning letter followed this inspection.

The company clarified that no data integrity issues were found. Furthermore, the letter is not expected to affect current revenues or disrupt supplies from the facility.

Glenmark has received similar warning letters in the past. One was for its Monroe facility in 2023, which was later re-inspected in June 2025. Another was for its Goa facility in November 2022.

A warning letter from the USFDA is a serious notice, usually indicating non-compliance that could pose risks to public health.

Glenmark stated that it remains committed to quality and CGMP compliance across all its manufacturing sites.

Separately, last week, Glenmark’s unit Ichnos Glenmark Innovation (IGI) signed a licensing deal with AbbVie for its experimental cancer drug ISB 2001. This drug is currently in Phase 1B trials for multiple myeloma. AbbVie will handle development and sales in major markets. Meanwhile, Glenmark will retain rights in India and emerging markets.

At 11:13 AM, the shares of Glenmark Pharma were trading 0.68% lower at Rs 2,166.30 on NSE.

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