Gland Pharma bags tentative USFDA nod for Angiotensin II Injection for low BP treatment
Hyderabad: Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (US FDA) for Angiotensin II Injection, 2.5 mg/mL Single Dose Vial.
"Gland Pharma believes that we are the only company with first to file for this product and may be eligible for 180 days of generic drug exclusivity. Gland Pharma will launch the product with its marketing partner on receipt of final approval," the Company stated.
Angiotensin II injections are used for the treatment of low blood pressure.
The Angiotensin II Injection, 2.5 mg/mL Single Dose Vial (RLD: Giapreza Injection) has US sales of approximately USD 38 million for twelve months ending in September 2023, according to IQVIA.
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Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become an injectable-focused company 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 the development, manufacturing, and marketing of sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
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