Glenmark Pharmaceuticals Expands Injectable Portfolio in the US

Glenmark Pharmaceuticals Inc, USA, the Subsidiary of Glenmark Pharmaceuticals Ltd announced the launch of Acetylcysteine Injection, marking an expansion of its injectable product portfolio. Glenmark’s version received FDA approval based on existing safety and efficacy data from the reference drug, acetadote injection.

About Acetylcysteine Injection

In a parallel development, Glenmark announced the acquisition and introduction of Acetylcysteine Injection in the US. The injection, available in 6 gm/30 mL (200 mg/mL) single-dose vials, is expected to deliver the same therapeutic effects as Acetadote Injection, manufactured by Cumberland Pharmaceuticals Inc. This launch represents an expansion of Glenmark’s injectable portfolio, reinforcing its commitment to providing affordable alternatives to branded medications.

Acetylcysteine is therapeutically employed both as an antidote for acetaminophen overdose and as a mucolytic to manage respiratory conditions. IQVIA sales data indicates that for the 12-month period ending in January 2025, the Acetadote injection market in the United States generated approximately USD 15.2 million in annual sales.

Recall of Atomoxetine Capsules

Glenmark is recalling approximately 1.476 million bottles of Atomoxetine Capsules across multiple strengths due to Current Good Manufacturing Practice (CGMP) deviations. The recall was triggered by the presence of N-Nitroso Atomoxetine impurity exceeding the permissible limit set by the US Food and Drug Administration (USFDA). Classified as a Class II recall, the withdrawal of the product indicates a risk of temporary or medically reversible adverse effects, with a low probability of serious consequences. Atomoxetine is a widely used medication for treating Attention Deficit Hyperactivity Disorder (ADHD), a neurodevelopmental disorder affecting focus, impulse control, and activity regulation.

Glenmark Pharma Share Performance

As of February 21, 2025, at 2:20 PM, the shares of Glenmark Pharma are trading at ₹1,302.85 per share, reflecting a surge of 1.87% from the previous day’s closing price. Over the past month, the stock has registered a loss of 7.89%.

Conclusion

While Glenmark Pharmaceuticals is addressing regulatory concerns with the recall of Atomoxetine Capsules, it is also expanding its footprint in the US market with the launch of Acetylcysteine Injection. These contrasting developments reflect the company’s dual focus on regulatory compliance and market growth.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions. 

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.