Granules India on Friday said that it has received the approval of the United States Food and Drug Administration (USFDA) for Venlafaxine Hydrochloride extended-release capsules, which are used in treating major depressive and anxiety-related conditions.
The company has obtained clearance for the capsules in the strength of 37.5 mg, 75 mg, and 150 mg.
The new drug is bioequivalent to the reference listed drug product (RLD), Effexor XR Extended-Release Capsules of Upjohn US 2 LLC.
Venlafaxine HCl extended-release capsules are indicated for the treatment of major depressive disorder, generalised anxiety disorder, social anxiety disorder, and panic disorder.
Granules India has now received a total of 56 Abbreviated New Drug Application (ANDA) approvals from the USFDA, which include 54 final and 2 tentative approvals.
According to IQVIA data for the 12 months that ended in March 2023, the current annual US market for Venlafaxine ER Capsules stood at approximately $153 million.
Founded in 1991, Granules India is a vertically integrated fast growing Indian pharmaceutical company. The company has seven manufacturing facilities out of which six are in India and one in the United States.
In an interaction with CNBC-TV18 on Wednesday, Krishna P Chigurupati, Chairman and MD, Granules India, said that the company has posted a 20 percent CAGR in the past 5 years and expects the same growth for the next 2 years.
For the entire financial year 2022-23, revenues stood 20 percent higher at Rs 4,512 crore and operating profit margins stood at 20.3 percent.
Shares of Granules India ended 0.52 percent lower at Rs 276.30 on Friday.
