Mahwah, New Jersey, March 3, 2025 – Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd., has announced the acquisition and launch of Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials in the U.S. market. This launch marks a strategic expansion of Glenmark’s injectable portfolio, particularly targeting the hospital segment.

Product Overview and Market Significance

Acetylcysteine Injection is used in clinical settings as an antidote for acetaminophen overdose, helping prevent liver damage caused by excessive acetaminophen ingestion. Glenmark’s newly introduced 6 gm/30 mL (200 mg/mL) Single-Dose Vial is therapeutically equivalent to Acetadote® Injection, a product by Cumberland Pharmaceuticals Inc.

Glenmark acquired the Abbreviated New Drug Application (ANDA) for Acetylcysteine Injection from Aspen Pharma USA Inc. The approval allows Glenmark to offer a cost-effective alternative to the existing brand-name medication, supporting hospitals and healthcare providers in treating patients with acetaminophen overdose.

Market Performance and Competitive Landscape

According to IQVIA™ sales data, for the 12-month period ending January 2025, the Acetadote® Injection market generated approximately $15.2 million in annual sales. Glenmark’s entry into this market strengthens its position in the U.S. generics and hospital injectables sector, which is a key focus for the company’s North American business strategy.

Strategic Business Impact

Speaking on the launch, Marc Kikuchi, President & Business Head, North America, emphasized the significance of this expansion:

"We are excited to announce the acquisition and launch of Acetylcysteine Injection in the U.S. market. This is a valuable addition to our growing injectable portfolio, particularly for the hospital segment, as we continue to expand our presence in the critical care space."

Glenmark Pharmaceuticals has been actively expanding its generics and injectables business, particularly in North America. This latest acquisition and product launch further solidifies its reputation as a key player in the U.S. pharmaceutical market.

About Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global pharmaceutical company with operations across branded, generics, and OTC segments. The company specializes in respiratory, dermatology, and oncology treatments and operates 11 world-class manufacturing facilities across four continents.

• Global Presence: Operates in over 80 countries.
• Top Rankings: Listed among the Top 100 Biopharmaceutical Companies (Pharmaceutical Sales, 2023).
• Commitment to Sustainability: One of the only two Indian pharmaceutical companies with Science-Based Target initiative (SBTi) approval for Greenhouse Gas (GHG) emission reduction.
• Corporate Social Responsibility: Over 3.3 million lives impacted through CSR programs in the past decade.

Looking Ahead

Glenmark’s U.S. expansion strategy aligns with its mission to provide affordable and high-quality pharmaceutical solutions. The launch of Acetylcysteine Injection is a crucial step in broadening its hospital-based treatment options while reinforcing its presence in the injectable drug segment.

With a strong pipeline of upcoming products, Glenmark remains committed to delivering innovative and accessible healthcare solutions worldwide.

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