Gland Pharma receives USFDA nod for pain management injection Acetaminophen
This Product is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older.
Hyderabad: Gland Pharma Limited, 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.
This Product is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, as well as moderate to severe pain with adjunctive opioid analgesics in adult and pediatric 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.
Medical Dialogues team had earlier reported that the Company had received approval from the USFDA for Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules. It was mentioned that the product was bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vitamin K1 Injectable Emulsion USP (10 mg/mL) by Hospira, Inc.
Read also: USFDA nod to Gland Pharma Vitamin K deficiency treatment drug
Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become a injectable-focused company 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 develops, manufactures, and market sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
