Indian generic injectable-focused pharmaceutical company Gland Pharma Limited said it has received tentative approval from the United States Food and Drug Administration (USFDA) for Angiotensin II Injection, 2.5 mg/mL Single Dose Vial.
Gland Pharma believes that it is the only company and the first to file for this product and may be eligible for 180 days of generic drug exclusivity.
The company will launch the product with its marketing partner on receipt of the final approval.
Angiotensin II is prescribed for increasing blood pressure in adult patients to treat low blood pressure with septic shock or distributive shock.
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.
Earlier, Gland Pharma had reported a 19.56 percent year-on-year (YoY) fall in consolidated net profit to Rs 194 crore for the July-September quarter of the current financial year.
The company reported a profit of Rs 241.2 crore in the same period last year.
Revenue came in at Rs 1,373.4 crore, up 31.52 percent from the year-ago quarter figure of Rs 1,044.4 crore.
Shares of the company were trading 0.95 percent down at Rs 1610.30 at 12.03pm on the NSE.
Also read: Gland Pharma Q2 results: Net Profit down 20% to Rs 194 crore
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
Find the best of Al News in one place, specially curated for you every weekend.
Stay on top of the latest tech trends and biggest startup news.
