Gland Pharma Ltd., a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Acetaminophen Injection, 10 mg/mL (500mg/50mL and 1000mg/100mL) Bags.

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., the company said in a statement.

This Product is indicated for the management of mild to moderate pain in adult and paediatric patients 2 years and older, as well as moderate to severe pain with adjunctive opioid analgesics in adult and paediatric patients 2 years and older.

The company expects to launch this product through its marketing partner in the near future. According to IQVIA, the product had US sales of approximately USD 55 million for the twelve months ending February 2025.

Established in 1978 in Hyderabad, Gland Pharma has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

It operates primarily under a business-to-business (B2B) model and has an excellent track record in developing, manufacturing, and marketing sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. It also enjoys the distinction of having pioneered Heparin technology in India.