Drug firm Granules India on Thursday said the US health regulator has issued two observations after inspection of Chantilly facility of its American arm in Virginia.
"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, USA, on August 21, 2019, with two minor observations," Granules India said in a filing to BSE.
This is a pre-approval inspection for seven products filed from this facility, it added.
"Granules Pharmaceuticals Inc will respond to these observations within the stipulated time period," the company said.
Shares of Granules India closed at Rs 88.60 per scrip on BSE, down 3.28 per cent from its previous close.
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