Gland Pharma Limited secures tentative approval from the USFDA for Angiotensin II Injection, 2.5 mg/mL Single Dose Vial. The company claims to be the first to file for this product, anticipating eligibility for 180 days of generic drug exclusivity.
Gland Pharma plans to launch the product in collaboration with its marketing partner upon final approval. Angiotensin II is prescribed to increase blood pressure in adult patients, addressing low blood pressure with septic shock or distributive shock.
The approved product, Angiotensin II Injection, 2.5 mg/mL Single Dose Vial (RLD: Giapreza Injection), recorded US sales of approximately USD 38 million for the twelve months ending in September 2023, according to IQVIA.
In the July-September quarter, Gland Pharma reports a 19.56% YoY decline in consolidated net profit, amounting to Rs 194 crore. However, the company’s revenue shows a positive trend, reaching Rs 1,373.4 crore, a 31.52% increase from the year-ago quarter’s figure of Rs 1,044.4 crore.
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