Latest news with #AngiotensinIIAcetateInjection
The Hindu
3 days ago
- Business
- The Hindu
Gland Pharma gets U.S. FDA nod for Angiotensin II Acetate Injection
Generic injectable focused Gland Pharma's version of La Jolla Pharma's Giapreza injection for increasing blood pressure in adults with septic or other distributive shock has received U.S. Food and Drug Administration approval. It is the exclusive first-to-file and consequently eligible for 180 days of generic drug exclusivity, Gland Pharma said on Wednesday, announcing U.S. FDA approval for its abbreviated new drug application related to Angiotensin II Acetate Injection 2.5 mg/mL. Bioequivalent and therapeutically equivalent to reference listed drug Giapreza of La Jolla Pharma LLC, the product had U.S. sales of around $58 million for the 12 months ended March 2025, Gland Pharma said citing IQVIA numbers. The company's shares closed 1.88% higher at ₹1,623.70 apiece on the BSE.
Business Standard
3 days ago
- Business
- Business Standard
Gland Pharma gets US FDA approval for hypotension treatment drug Angiotensin II
Gland Pharma said that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Angiotensin II Acetate Injection. 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 $58 million for the twelve months ending March 2025. Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered heparin technology in India. The company's consolidated net profit declined 3.06% to Rs 186.54 crore as net sales fell by 7.32% to Rs 1424.91 crore in Q4 FY25 as compared with Q4 FY24. The scrip rose 0.32% to currently trade at Rs 1598.95 on the BSE.
Business Upturn
4 days ago
- Business
- Business Upturn
Gland Pharma gets USFDA nod for Angiotensin II Acetate Injection, secures 180-day exclusivity
By Markets Desk Published on June 4, 2025, 08:20 IST Gland Pharma Limited has received final 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 injectable product is bioequivalent and therapeutically equivalent to the reference listed drug GIAPREZA®, developed by La Jolla Pharma LLC. It is indicated for increasing blood pressure in adults suffering from septic or other distributive shock. Importantly, Gland Pharma is the exclusive First-to-File applicant for this product and has secured 180 days of generic drug exclusivity in the U.S. market. According to IQVIA data, US sales of Angiotensin II Acetate Injection stood at approximately USD 58 million for the twelve months ending March 2025, highlighting the commercial opportunity for Gland Pharma. This approval further strengthens Gland Pharma's injectables portfolio and underscores its regulatory and filing capabilities in complex products. Markets Desk at
