USFDA approves Gland Pharma Vasopressin in 5% Dextrose RTU Injection

This product is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.;

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-08-27 07:00 GMT   |   Update On 2025-08-27 07:00 GMT
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Hyderabad: Gland Pharma Limited, a generic injectable & ophthalmic focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Vasopressin in 5% Dextrose Injection, 40 Units per 100 mL (0.4 Units per mL) RTU Vials and tentative approval for Vasopressin in 5% Dextrose Injection, 20 Units per 100 mL (0.2 Units per mL) RTU Vials.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL (0.4 Units per mL) and 20 Units per 100 mL (0.2 Units per mL) of PH Health Limited.
This Product is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
According to IQVIA, the product had US sales of approximately USD 45 million for the twelve months ending June 2025.
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In a separate development in mid-August, Gland Pharma Limited, also received approval from the USFDA for its ANDA filed through its partner for Norepinephrine Bitartrate in 5% Dextrose Injection, 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) Single-Dose Bags. This product is indicated to raise blood pressure in adult patients with severe, acute hypotension.

Read also: Gland Pharma secures USFDA okay for Norepinephrine Bitartrate in 5% Dextrose Injection Bags

Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contractmanu facturer 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.

Read also: Gland Pharma Pashamylaram facility receives GMP compliance certificate from Danish Medicines Agency

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