USFDA grants Gland Pharma a preliminary approval for a blood pressure medication
As the first business to file for this product, Gland Pharma may be qualified for 180 days of exclusivity for generic drugs.
The US Food and Drug Administration (USFDA) has given provisional clearance for Angiotensin II injectable, 2.5 mg/mL single dosage vial, to the Indian generic injectable business Gland Pharma Ltd.
Gland Pharma thinks it is the first and only business to file for this product, and it could be qualified for 180 days of exclusivity for generic drugs.
The business will introduce the product with its marketing partner after obtaining final clearance.
Adult patients with elevated blood pressure are administered Angiotensin II to treat low blood pressure associated with distributive or septic shock.
According to IQVIA, angiotensin II injection, 2.5 mg/mL single dosage vial (RLD: Zyapreza Injection), produced US sales of around US$38 million for the 12 months that ended in September 2023.
Prior to this, Gland Pharma had disclosed a 19.56 percent YoY decrease in consolidated net profit for the current fiscal year's July–September quarter, coming in at Rs 194 crore.
A profit of Rs 241.2 crore had been reported by the corporation during the same time previous year.
Revenue increased by 31.52% to Rs 1,373.4 crore from Rs 1,044.4 crore in the same period last year.
The company's shares were down 0.95 percent at Rs 1610.30 on the NSE at 12:03 PM.
No comments:
Post a Comment