Thursday, August 7, 2025

Glenmark Pharmaceuticals’ USA arm reaches $37.75 million settlement in US antitrust lawsuit

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Glenmark Pharmaceuticals Ltd on Wednesday (August 7) said its subsidiary Glenmark Pharmaceuticals Inc., USA, has agreed to a $37.75 million settlement in connection with antitrust litigation in the United States.The lawsuits, consolidated in the Eastern District of Pennsylvania, involve allegations of price-fixing, market allocation, and other anticompetitive conduct in the generic drug industry.The settlement is with the putative direct purchaser class and is subject to court approval. Payment will be made in two instalments — $11.1 million following preliminary court approval and $26.65 million on or before April 1, 2026.

Also Read: Glenmark Pharma shares cool off after hitting 20% upper circuit post mega ISB 2001 dealGlenmark USA is named in multiple class actions and direct-action suits, brought by direct purchasers, end-payers, indirect purchasers, and private plaintiffs. The cases allege both drug-specific conspiracies and a broader conspiracy involving multiple generic drug manufacturers.The company continues to deny all allegations and has stated that the settlement does not constitute an admission of liability or wrongdoing. The agreement was reached to resolve the dispute and avoid ongoing uncertainty.

Last month, the US Food and Drug Administration (USFDA) issued a Warning Letter to Glenmark Pharmaceuticals for its Pithampur manufacturing facility, following an inspection conducted between February 3 and February 14, 2025.Also Read: Glenmark Pharma’s innovation arm signs exclusive licensing agreement with AbbVie for ISB 2001According to the letter, the facility’s methods, controls, and overall operations failed to comply with Current Good Manufacturing Practice (CGMP) regulations.The agency flagged inadequate investigations into dissolution failures in potassium chloride extended-release capsules and another product, citing a lack of sufficient scientific justification in the company’s responses.The FDA also raised concerns over delayed stability testing, which resulted in the late detection of product failures and subsequent delays in initiating recalls and issuing field alerts.Shares of Glenmark Pharmaceuticals Ltd ended at ₹2,020.30, down by ₹31.15, or 1.52%, on the BSE.Also Read: Glenmark Pharma announces India launch of blood cancer treatment Brukinsa

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