Glenmark Pharma to Launch Ropivacaine Injection in US

Glenmark Pharmaceuticals Inc., USA, has announced the upcoming launch of its Ropivacaine Hydrochloride Injection USP in three single-dose vial strengths: 40 mg/20 mL (2 mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL).

The company also made a statement that its product meets criteria for bioequivalence and therapeutic equivalence with the reference drug i.e. Naropin Injection that is a product of Fresenius Kabi USA, LLC (NDA 020533). The injection will be available to customers from the time when the company plans to start its operations in November 2025, thus it will be a new and noteworthy addition to Glenmark’s expanding injectable portfolio in the North American region.

Based on the data provided by IQVIA, Naropin Injection has been able to generate sales of close to $20.9 million over the last 12 months in the US market, thus targeting a major market opportunity which is the potential of Glenmark's product in the US.

Also Read: Alembic Pharma Receives USFDA Approval for Injectable Drug

North America President & Business Head, Marc Kikuchi said, "The availability of Ropivacaine Hydrochloride Injection USP in various strengths will be welcomed by us to the market. Our injectable portfolio gets enhanced with this launch and it also represents our pledge towards making quality enabled affordable alternatives available to the patients."

Glenmark Pharmaceuticals, India-based, is a leading global research-driven company with presence across Branded, Generics, and OTC segments, and focusing on therapeutic areas such as respiratory, dermatology, and oncology. The US launch of Ropivacaine Hydrochloride Injection is just one example of Glenmark's strategy to diversify its global presence, offer innovative and affordable medicines, and be a prominent player in the global pharma sector.