Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the acquisition and launch of acetylcysteine injection, 6 gm/30 mL (200 mg/mL) single-dose vials.
Glenmark’s 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 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 sales data for the 12-month period ending January 2025, the Acetadote injection, 6 gm/30 mL (200 mg/mL) single-dose vials market 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 US market as we continue to drive growth for the hospital segment.”
Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company, having a presence across branded, generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries.
