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Bengaluru, March 3, 2025: Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the acquisition and launch¹ of Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials. Glenmark����ֱ�� Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials can be expected to have the same therapeutic effect as the listed drug product upon which the Agency relied as the basis of safety and effectiveness, Acetadote®² Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials of Cumberland Pharmaceuticals Inc. Glenmark acquired the ANDA for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials from Aspen Pharma USA Inc.

According to IQVIA^TM sales data for the 12-month period ending January 2025, the Acetadote® Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials market² achieved annual sales of approximately $15.2 million*.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, “We are excited to announce the acquisition and launch of Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials. This is a great addition to our injectable portfolio in the U.S. market as we continue to drive growth for the hospital segment.”