The company has acquired the abbreviated new drug application (ANDA) for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) single-dose vials from Aspen Pharma USA Inc.
Acetylcysteine is used for respiratory disease with excessive mucus. It acts as mucolytic (loosen mucus in airways) when used in oral preparations while when used as injection it treats paracetamol overdose toxicity.
The company’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 2 Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials of Cumberland Pharmaceuticals 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 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.”
Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with a presence across specialty, generics, and OTC businesses. The company has 11 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries.
On a consolidated basis, the company reported a net profit of Rs 348 crore in Q3 FY25 compared with a net loss of Rs 449.6 crore in Q3 FY24. Revenue from operations surged 35.1% YoY to Rs 3,387.6 crore in the quarter ended 31 December 2024.