Glenmark Pharmaceuticals Inc., USA, is set to expand its presence in the U.S. pharmaceutical market with the upcoming launch of Ropivacaine Hydrochloride Injection USP. The product will be available 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). Glenmark plans to begin distribution in November 2025.
The new Ropivacaine Hydrochloride Injection is bioequivalent and therapeutically equivalent to the reference drug, Naropin® Injection (Fresenius Kabi USA, LLC, NDA – 020533). This ensures healthcare providers and patients can expect the same efficacy and safety profile as the established brand.
According to IQVIA® sales data for the 12 months ending August 2025, the Naropin® Injection market, which includes both brand and therapeutic equivalents, generated annual sales of approximately $20.9 million. Glenmark’s new offering provides an additional choice for hospitals and clinics, addressing the growing demand for effective local anesthetics.
Glenmark emphasizes that its Ropivacaine Hydrochloride Injection is approved only for the specific indications listed on its label, ensuring precise and safe usage in medical procedures.
With this launch, Glenmark continues its commitment to innovative, high-quality, and affordable pharmaceutical solutions in the United States, strengthening its footprint in the local anesthetic segment.
