USFDA approves Gland Pharma Vasopressin in 5% Dextrose RTU Injection

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-08-27T12:30:28+05:30 | Updated On 27 Aug 2025 12:30 PM IST

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

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.

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.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751