Glenmark Pharmaceuticals USA has introduced a multiple-dose vial of epinephrine injection.
Glenmark Pharmaceuticals Inc, USA, has launched Epinephrine Injection USP, a bioequivalent and therapeutically equivalent product to the reference listed drug manufactured by BPI Labs, LLC. The product is available in a 30 mg/30 mL (1 mg/mL) Multiple-Dose Vial and is intended for the U.S. market. According to IQVIA sales data, the Epinephrine Injection market had annual sales of approximately USD 67.6 million for the 12 months ending October 2025. This launch expands Glenmark’s institutional product portfolio and reinforces its commitment to providing high-quality, affordable treatment options.
Glenmark Pharmaceuticals Limited is a prominent Indian multinational pharmaceutical company that has been in operation since 1977. The company has grown from its origins in generic medicines and active pharmaceutical ingredients (APIs) to become a research-led global healthcare organization with a presence in over 80 countries. Glenmark’s core therapeutic expertise includes respiratory, dermatology, oncology, cardiovascular, and anti-infective treatments, with multiple R&D centres and manufacturing facilities across India and internationally.
In recent years, Glenmark has diversified into innovative drug development and biosimilars, while maintaining a strong portfolio of branded generics in high-growth markets. The company has also entered strategic collaborations and licensing deals to advance novel therapies, particularly in oncology. Despite facing quality control challenges in some manufacturing facilities, Glenmark continues to pursue a transformation towards a more innovation-centric business model aimed at increasing its branded portfolio and long-term global competitiveness.
The launch of Epinephrine Injection USP is part of Glenmark’s strategy to strengthen its institutional channel presence and improve access to essential medicines. According to Marc Kikuchi, President and Business Head for North America at Glenmark, the launch supports the company’s commitment to providing high-quality, affordable treatment options. With its robust revenue growth and expanding demand in key markets such as North America and Europe, Glenmark is well-positioned to continue its growth and expansion in the global pharmaceutical market.
The US FDA has issued a recall for an antifungal shampoo manufactured by Sun Pharma.
The US Food and Drug Administration (USFDA) has announced a recall of over 17,000 units of antifungal shampoo, Ciclopirox Shampoo, due to manufacturing issues. The recall was initiated by Taro Pharmaceutical Industries, the US arm of Sun Pharma, on December 9. The shampoo is used to treat seborrheic dermatitis, a condition that causes dry, flaky, and itchy skin. The recall was classified as a Class II recall, which means that the product’s use may lead to temporary or medically reversible health consequences, but the likelihood of serious adverse health outcomes is minimal.
The recall was due to “failed impurity/degradation specifications,” according to the USFDA. Taro Pharmaceutical Industries is a private company and a wholly-owned subsidiary of Sun Pharma, which acquired the Israel-based company in a deal valued at $347.73 million last year. Sun Pharma has been the majority shareholder of Taro since 2010. Taro primarily focuses on dermatology and produces a wide range of prescription and over-the-counter products.
The recall is a setback for Sun Pharma, which is a leading exporter to the US market. In the second quarter of FY26, the company reported revenue of Rs 14,478 crore, with a net profit of Rs 3,118 crore, a 2.56% increase year-on-year. However, formulation sales in the US declined 4.1% to $496 million. The recall highlights the importance of quality control and regulatory compliance in the pharmaceutical industry.
The USFDA’s Enforcement Report noted that the recall was nationwide and affected 17,664 units of the Ciclopirox Shampoo. The company has taken prompt action to address the issue, and the recall is expected to minimize any potential harm to consumers. The incident serves as a reminder of the need for pharmaceutical companies to maintain high standards of quality and manufacturing practices to ensure the safety and efficacy of their products.
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