Glenmark Pharma to launch Ropivacaine Hydrochloride Injection USP in US

Glenmark Pharmaceuticals Inc., USA, has announced the upcoming launch of Ropivacaine Hydrochloride Injection USP in three concentrations — 40 mg/20 mL (2 mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL) — in single-dose vials. Distribution is scheduled to begin in November 2025.

 

The product is approved as bioequivalent and therapeutically equivalent to the reference listed drug, Naropin Injection, marketed by Fresenius Kabi USA LLC. It is used as a local anaesthetic, which produces numbness or loss of feeling for surgical procedures, labour, and acute pain management.

 

Marc Kikuchi, president and business head, North America, said: “This launch represents another important addition to Glenmark’s expanding injectable portfolio and reinforces our dedication to bringing quality and affordable alternatives to market for patients in need.”

 

 

According to IQVIA sales data for the 12-month period ending August 2025, Naropin achieved annual US sales of approximately $20.9 million, covering all approved indications. Glenmark’s product will be marketed for the indications listed on its approved label, which may not include all uses of the reference drug.

 

The launch adds to Glenmark’s portfolio of injectable medications in North America. The Ropivacaine Hydrochloride Injection is intended for clinical use according to the approved label, with multiple dosage options allowing flexibility for medical administration.

 

Glenmark Pharmaceuticals, the parent company, operates in branded, generic, and over-the-counter (OTC) segments across therapeutic areas such as respiratory, dermatology, and oncology. The company has 11 manufacturing facilities across four continents and operates in over 80 countries.