Drug firm Alembic Pharmaceuticals Wednesday said it has received approval from the US health regulator for Tadalafil tablets, indicated for the treatment of erectile dysfunction.
The approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Tadalafil tablets USP, in the strengths of 2.5 mg, 5mg, 10mg and 20 mg, Alembic Pharmaceuticals said in a filing to BSE.
The product is generic version of Eli Lilly and Company's Cialis tablet.
Quoting IQVIA data, Alembic Pharma said Tadalafil Tablets have an estimated market size of USD 1.8 billion for twelve months ending December 2018.
The company currently has a total of 89 ANDA approvals (77 final approvals and 12 tentative approvals) from USFDA, it added.
Shares of Alembic Pharmaceuticals were trading 0.23 per cent lower at Rs 528.35 apiece on BSE.
Disclaimer: No Business Standard Journalist was involved in creation of this content
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 →
Smart Quarterly
₹900
3 Months
₹300/Month
Smart Essential
₹2,700
1 Year
₹225/Month
Super Saver
₹3,900
2 Years
₹162/Month
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