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

This Product is indicated to raise blood pressure in adult patients with severe, acute hypotension.

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-08-12 09:00 GMT | Update On 2025-08-12 09:00 GMT

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 (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.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD),NOREPINEPHRINE BITARTRATEIN 5% DEXTROSE of Baxter Healthcare Corp.

This Product is indicated to raise blood pressure in adult patients with severe, acute hypotension.

We are the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity.

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

According to IQVIA, the product had US sales of approximately USD 55 million for the twelve months ending June 2025.

In June, the company also received USFDA approval for its ANDA for Angiotensin II Acetate Injection 2.5 mg/mL, used for increasing the blood pressure in adults with septic or other distributive shock.

Read also: USFDA greenlights Gland Pharma BP injection in adults with septic shock

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 bags USFDA nod for Cangrelor for Injection

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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

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

This Product is indicated to raise blood pressure in adult patients with severe, acute hypotension.

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