“We have received a communication from the US Food and Drug Administration (US FDA) releasing a copy of the Establishment Inspection Report (EIR) in respect of the company's Dadra facility inspection based upon our responses to the Form-483 observation letter,” Sun Pharma said in a BSE filing.
Dadra is Sun Pharma’s second-largest plant in India, and had received 11 adverse observations in a US FDA inspection in April. These pertained to incomplete batch records, improper storage of drugs and inadequate powers to quality control unit.
This is the second plant to clear regulatory hurdle after Mohali, which was cleared of an import alert in March.
At 09:32 AM; the stock was up 3% at Rs 541 on the BSE as compared to 0.11% decline in the S&P BSE Sensex. A combined 2.31 million shares changed hands on the counter on the 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
)