“The US Food and Drug Administration (USFDA) have issued a Warning Letter for the company's Unit-II at Visakhapatnam,” Divis Laboratories said in a BSE filing.
The company responded to the US-FDA inspection observations with an appropriate remediation process to overcome the deficiencies observed, it added.
The company said, in the import alert issued, US-FDA has exempted several products manufactured at the company's Unit-II at Visakhapatnam, Andhra Pradesh. It will continue to supply these active ingredients to meet its obligations to the customers.
“Divi's Labs, along with external consultants and subject matter experts, are working to address the concerns of the US-FDA and is making all efforts to fully meet the compliance requirements. We will respond to this Warning Letter with a detailed plan within the stipulated time,” it added.
In past six months, the stock has underperformed the market by falling 52% as compared to 4% rise in the S&P BSE Sensex.
At 9:21 am; the stock was down 1.7% at Rs 620 on BSE as compared to 0.34% rise in the benchmark index. A combined 734,175 equity shares changed hands on the counter on BSE and NSE so far.
One subscription. Two world-class reads.
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
)