Gland Pharma Limited, a leading generic injectable pharmaceutical company, has received approval from the U.S. Food and Drug Administration (USFDA) for its Acetaminophen Injection (10 mg/mL, 500mg/50mL, and 1000mg/100mL) Bags. This milestone strengthens Gland Pharma’s position in the U.S. pharmaceutical market.
The newly approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Acetaminophen Injection by B. Braun Medical, Inc. It is indicated for managing mild to moderate pain in adult and pediatric patients aged 2 years and older. Additionally, it can be used alongside opioid analgesics to treat moderate to severe pain in the same patient group.
Gland Pharma plans to launch the product soon through its marketing partner, enhancing its injectable pain management portfolio. According to IQVIA, the Acetaminophen Injection market in the U.S. recorded sales of approximately $55 million for the twelve months ending February 2025.
This approval marks a significant step for Gland Pharma in expanding its global reach and reinforcing its commitment to delivering high-quality, cost-effective injectable medications.
About Gland Pharma
Founded in 1978 in Hyderabad, Gland Pharma has grown from a contract manufacturer to a global leader in injectable pharmaceuticals, operating across 60+ countries, including the U.S., Europe, Canada, Australia, and India. The company specializes in sterile injectables such as vials, ampoules, pre-filled syringes, infusions, oncology, and ophthalmic solutions.
