The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Acetaminophen Injection, 500 mg/50 mL (10 mg/mL) and 1000 mg/100 mL (10 mg/mL), of B. Braun Medical, Inc.
This product is indicated for the management of mild to moderate pain in adult and pediatric patients aged 2 years and older, as well as moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients aged 2 years and older.
According to IQVIA, the product had US sales of approximately $55 million for the twelve months ending February 2025. The company expects to launch this product through its marketing partner in the near future.
Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered heparin technology in India.
Gland Pharma’s consolidated net profit increased 6.67% to Rs 204.70 crore despite a 10.42% decline in revenue from operations to Rs 1,384.1 crore in Q3 FY25 over Q3 FY25.