USFDA greenlights Gland Pharma BP injection in adults with septic shock
Medical Negligence
Hyderabad: Gland Pharma Limited, a generic injectable & ophthalmicfocused pharmaceutical company, has announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL.
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), GIAPREZA of La Jolla Pharma LLC.
This Product is indicated for increasing the blood pressure in adults with septic or other distributive shock.
Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity.
According to IQVIA, the product had US sales of approximately USD 58 million for the twelve months ending March 2025.
Additionally in April, Gland Pharma Limited received approval from the USFDA for its ANDA for Latanoprostene Bunod Ophthalmic Solution,0.024%, a bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024%, of Bausch and Lomb, Inc.
In the same month, the company received USFDA approval for Acetaminophen Injection, 10 mg/mL (500mg/50mL and 1000mg/100mL) Bags, a 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.
Read also: Gland Pharma receives USFDA nod for pain management injection Acetaminophen
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.
