Gland Pharma Gets USFDA Approval for Angiotensin II Acetate Injection..

Varahimedia.com,Hyderabad, June 5th, 2025: Gland Pharma Limited, a leading pharmaceutical company specializing in injectable and ophthalmic products, has received approval from the U.S.

Varahimedia.com,Hyderabad, June 5th, 2025: Gland Pharma Limited, a leading pharmaceutical company specializing in injectable and ophthalmic products, has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection, 2.5 mg/mL.

This product has been found to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), GIAPREZA® by La Jolla Pharma LLC. It is prescribed to raise blood pressure in adults experiencing septic or other forms of distributive shock.

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Notably, Gland Pharma is the exclusive First-to-File applicant for this product, granting it 180 days of generic marketing exclusivity in the U.S. market.

As per IQVIA data, Angiotensin II Acetate Injection generated approximately USD 58 million in U.S. sales for the 12-month period ending March 2025.