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Glenmark Pharma Shares Gain as Arm Reaches Settlement in US Antitrust Suit 

Envafolimab is currently in Phase 3 testing in China, sponsored by 3D Medicines Inc.
Envafolimab is currently in Phase 3 testing in China, sponsored by 3D Medicines Inc.

Shares of Glenmark Pharmaceuticals Ltd were trading 1% higher on 7 August after the subsidiary of the company, Glenmark Pharmaceuticals Inc., USA, reached a $37.75 million settlement in antitrust litigation in the United States.

The complaints, consolidated in the Eastern District of Pennsylvania, allege price fixing, market allocation, and other anticompetitive behaviour in the generic medication sector.

The settlement is with the alleged direct purchaser class and requires judicial approval.  Payment will be provided in two instalments. The first instalment of $11.1 million is to be paid upon preliminary court approval, and the remaining $26.65 million on or before 1 April 2026.

Glenmark USA is named in several class actions and direct-action lawsuits filed by direct purchasers, end-payers, indirect purchasers, and individual plaintiffs. The cases claim both medication-specific schemes and a larger conspiracy involving numerous generic medicine producers.

The corporation continues to refute all charges, claiming that the payment does not reflect an acknowledgement of culpability or wrongdoing. The deal was struck to end the issue and prevent further uncertainty.

Glenmark Pharmaceuticals received a Warning Letter from the US Food and Drug Administration (USFDA) this month for its Pithampur manufacturing facility, which was inspected between 3 February and 14 February 2025.

According to the letter, the facility’s techniques, controls, and overall operations did not adhere to Current Good Manufacturing Practice (CGMP) rules.

The government reported insufficient investigations into disintegration problems in potassium chloride extended-release capsules and another product, noting a lack of scientific rationale in the company’s comments.

The FDA also expressed worry about the delayed stability testing, which resulted in late detection of product failures and consequent delays in initiating recalls and sending field notifications.

At 12:28 pm, the shares of Glenmark Pharmaceuticals were trading 0.039% higher at Rs 2,026.40 on NSE.

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