FDA WARNING_LETTER - Glenmark Pharmaceuticals Ltd - February 14, 2025

Glenmark Pharmaceuticals Limited, located in Pithampur, India, was inspected by the FDA from February 3 to 14, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in Title 21 of the Code of Federal Regulations, parts 210 and 211. The FDA identified that Glenmark"s methods, facilities, or controls did not conform to CGMP, leading to the adulteration of their drug products under the Federal Food, Drug, and Cosmetic Act.

Key violations included the failure to thoroughly investigate unexplained discrepancies or failures of drug batches to meet specifications, particularly concerning potassium chloride extended-release capsules. The investigation into dissolution failures was inadequate, lacking sufficient scientific evidence to support identified root causes. Despite recalling affected batches, Glenmark did not sufficiently address all potential process changes impacting dissolution results.

Additionally, similar issues were found with another product, the (b)(4) capsule, where process parameter variations were inadequately validated before further distribution. Glenmark"s corrective actions were deemed insufficient, as they did not complete necessary validation studies before implementing changes.

The FDA requires Glenmark to conduct comprehensive investigations into the root causes of these failures, validate process changes, and ensure compliance with CGMP regulations to prevent future occurrences. The company must provide detailed plans and evidence of effective remediation to address these significant lapses in manufacturing control.