Glenmark Pharma’s Share Price Remains Flat Amid USFDA Warning Letter to Indore Facility

Market Performance

Glenmark Pharma's share price remained flat at ₹2,183 apiece during early trading hours at 9:35 AM on Monday, July 14.

• The stock is currently under F&O ban, restricting the creation of any new derivative positions.
• Glenmark Pharma's share price has surged 35.2% so far in 2025, indicating strong performance despite recent regulatory developments.

Main News

On Sunday, July 13, Glenmark Pharmaceuticals Ltd. reported that the USFDA issued a warning letter to its Indore facility.

• The USFDA inspected between February 3 and February 14, 2025.
• This inspection led to the facility being marked with Official Action Indicated (OAI) status in May 2025.
• The company clarified that no data integrity issues were mentioned in the warning letter.
• Glenmark Pharma confirmed that the warning letter is not expected to impact current revenue or supply chain operations from the Indore site.

This is not the first time Glenmark has faced regulatory scrutiny:

• In 2023, its Monroe facility also received a warning letter.
  • That facility was re-inspected and issued five observations in June 2025.
• Earlier, the Goa facility received a similar warning letter in November 2022.

A warning letter from the USFDA typically reflects non-compliance with regulatory standards and can pose reputational and operational risks, though the current situation appears contained.

Company Details

Despite regulatory headwinds, Glenmark continues to expand its innovation pipeline. In a separate development:

• Glenmark's subsidiary Ichnos Glenmark Innovation (IGI) has entered an exclusive licensing agreement with global biopharma major AbbVie.
• The deal focuses on ISB-2001, a tri-specific antibody under development for multiple myeloma.
• While AbbVie will handle development and commercialization in the US, Europe, Japan, China, and other developed markets, Glenmark retains rights in India and emerging markets.
• ISB-2001 is currently in Phase 1B of clinical testing.

Summary of the Article

• Glenmark Pharma's share price held steady at ₹2,183 on July 14, amid the USFDA issuing a warning letter to its Indore unit.
• The facility was previously tagged with OAI status following a February 2025 inspection.
• No impact is anticipated on revenues or product supply due to the warning letter.
• The company also secured a strategic licensing deal for its oncology pipeline with AbbVie, showcasing its commitment to innovation.
• The stock remains in the F&O ban list, and overall, has gained 35.2% year-to-date.