Gland Pharma Receives Tentative Approval For Angiotensin II Injection

Gland Pharma Limited, a generic injectable focused pharmaceutical company, received tentative approval from the United States Food and Drug Administration (US FDA) for Angiotensin II Injection, 2.5 mg/mL Single Dose Vial, the company on Wednesday announced through an exchange filing.

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 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.

Gland Pharma Limited shares

The shares of Gland Pharma Limited on Wednesday at 12:02 pm IST were at Rs 1,612, down by 0.85 percent.