Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals has initiated a recall of approximately 1.5 million bottles of its ADHD medication in the U.S., following findings of safety violations. The U.S. Food and Drug Administration (FDA) announced the recall due to "CGMP Deviations," which refers to violations of current good manufacturing practices. The recall affects around 1.476 million bottles of Atomoxetine Capsules, available in various strengths ranging from 10 mg to 100 mg. The FDA reported that the recall was prompted by the presence of N-Nitroso Atomoxetine impurity exceeding the recommended limits. Glenmark Pharmaceuticals Inc., based in New Jersey and a subsidiary of the Mumbai-based company, initiated this Class II recall on January 29, 2025. A Class II recall indicates that exposure to the violative product may lead to temporary or medically reversible adverse health consequences, though the likelihood of serious consequences is considered remote. ADHD, or Attention Deficit Hyperactivity Disorder, is a prevalent neurodevelopmental disorder, primarily affecting children's ability to focus and control impulses. The recall highlights ongoing concerns regarding drug safety and regulatory compliance in the pharmaceutical industry.

MAHWAH, N.J., March 3, 2025 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the acquisition and launch1 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®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™ sales data for the 12-month period ending January 2025, the Acetadote® Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials market3 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." About Glenmark Pharmaceuticals Ltd. Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) 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. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions. For more information, visit . You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma). References: 1Glenmark's Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials is only approved for the indication(s) listed in Glenmark's approved label. 2All brand names and trademarks are the property of their respective owners. 3Market includes brand and all available therapeutic equivalents. Note: IQVIA data obtained by Glenmark is only available for all approved RLD indications. Glenmark's product is only approved for the indications listed in Glenmark's approved label and is not marketed for all RLD indications. *IQVIA™ National Sales Perspectives: Retail & Non-Retail, January 2025. Logo: SOURCE Glenmark Pharmaceuticals Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Glenmark Pharmaceuticals has officially launched its generic version of Epinephrine injection in the United States, a significant move that positions the company to capitalize on a market valued at approximately $42.7 million. The newly introduced 10 mg/10 mL (1 mg/mL) multiple-dose vial is bioequivalent and therapeutically equivalent to the reference drug from BPI Labs, LLC. This launch is crucial as it qualifies for 180 days of competitive generic therapy (CGT) exclusivity, providing Glenmark a strategic advantage in the market. The Epinephrine injection is primarily used to treat hypotension associated with septic shock and for emergency responses to allergic reactions. Marc Kikuchi, President and Business Head for North America at Glenmark, emphasized that this launch enhances the company's institutional product portfolio while reinforcing their commitment to offering quality and affordable healthcare alternatives. With this introduction, Glenmark continues to strengthen its presence in the U.S. pharmaceutical market, responding to increasing demand for effective and accessible treatment options. The launch not only marks a milestone for Glenmark but also contributes to the broader goal of improving patient care through affordable medication.