J B Chemicals & Pharmaceuticals today said it has received US health regulator's nod to market a generic version of diclofenac sodium tablets, an anti-inflammatory drug, in the American market.
The company has received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application for diclofenac sodium tablets in strengths of 25 mg and 50 mg, J B Chemicals said in a filing to the National Stock Exchange (NSE).
The company already markets 75 mg tablets of diclofenac sodium tablets in the US market. With this new approval, the company has now full range of the drug to offer in the US market, it said.
As the firm has established partners in the US, it expects to commercialise this approval in fourth quarter of this year, it added.
The estimated market in the US for diclofenac sodium formulations per annum is nearly $400 million, it said.
Shares of J B Chemicals & Pharmaceuticals today closed at Rs 135.70 on the NSE, up 8.96 per cent from its previous close.
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