April 2025
Glenmark Pharmaceuticals Inc., USA, has made an official announcement regarding the launch of the generic version of Vancomycin Hydrochloride for Injection USP. The launch presents Vancomycin Hydrochloride in single-dose vials containing 750 mg, 1.25 g, and 1.5 g for intravenous use against systemic bacterial infections, marking yet another significant addition to Glenmark's institutional portfolio.
According to IQVIA™ sales data for the 12 months ended 30 January 2025, the Vancomycin Hydrochloride for Injection USP market has recorded an annual sale of around $39.3 million. Glenmark proposes this latest delivery system to make the most of this market opportunity by providing a high-quality and economical alternative to the reference-listed product made by Mylan Laboratories Limited under NDA 209481.
The generic formulation recently launched by Glenmark is bioequivalent and therapeutically available to Mylan's Vancomycin Hydrochloride for Injection USP. The evidence from bioequivalence studies establishes the generic formulation to be of the same dosage form, strength, route of administration, quality, and performance characteristics as those of the original branded product.
Vancomycin is a widely used antibiotic for treatments of serious bacterial infections ranging from those due to Gram-positive organisms resistant to other antibiotics. Its clinical use is mostly on the intravenous route for the treatment of sepsis, endocarditis, bone infections, and infections of the respiratory tract.
Marc Kikuchi, President and Business Head for North America, highlighted the launch by stating: "We are thrilled to welcome Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial, and 1.5 g/vial (Single-dose vial) into our pool of quality offerings for institutions. "The concerted efforts of Glenmark include increasing its footprint in the institutional segment with the introduction of quality generics that are priced fairly. The company’s strategy is to provide reliable treatment options in critical care settings which also goes hand in hand with its larger goal of furthering access to essential medicines.
The Vancomycin Hydrochloride for Injection USP market has remained intensely instrumental with numerous established firms offering their branded and generic comparable formulations. However, Good Glenmark's Entry into this market expected it to raise its market share. More, this demand for effective antibacterial treatment will grow. Glenmark has additional advantages, such as its expertise in injectable, high-quality generic formulation development and its ability to efficiently maneuver regulatory pathways. Thus, Glenmark stands excellently poised for better opportunities in the market. Ongoing research and development activities continue to fuel innovation in the company's institutional portfolio.
Glenmark Pharmaceuticals intends to utilize its distribution network and market experience for the effective promotion of its new Vancomycin product. The launch of the generic Vancomycin formulation can be seen as a strategic milestone for the company in its quest to build up its institutional portfolio. Glenmark wants to place itself as a major contender in the market by providing a cost-effective treatment for serious bacterial infections. The healthcare fraternity would closely watch Glenmark's performance in the highly competitive market since the demand for effective antibacterial treatment is on the rise globally.
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