"The company has received approval from the United States Food and Drug Administration (USFDA) for its ANDA for Amantadine Hydrochloride capsules USP 100 mg," Alembic Pharmaceuticals said in a BSE filing.
The approved Abbreviated New Drug Application (ANDA) is equivalent to Symmetrel capsules of Endo Pharmaceuticals.
Also Read
The drug is also used in the treatment of parkinsonism and drug-induced extrapyramidal reactions, it added.
According to IMS December 2016 data, Amantadine Hydrochloride capsules had an estimated market size of $37 million.
The company now has a total of 58 ANDA approvals from the USFDA.
The stock was trading at Rs 537.15, up 0.99 per cent, on the BSE.
You’ve reached your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →*Subscribe to Business Standard digital and get complimentary access to The New York Times
Smart Quarterly
₹900
3 Months
₹300/Month
SAVE 25%
Smart Essential
₹2,700
1 Year
₹225/Month
SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months
Super Saver
₹3,900
2 Years
₹162/Month
Subscribe
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors
Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share
Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor
Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements
Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app
SAVE 25%