 "Dr Reddy's SEZ unit completes USFDA inspection for second time")
Hyderabad-based Dr Reddy's Laboratories informed the stock exchanges that the US Food and Drug Administration (USFDA) has completed the audit of its formulations at unit II in Srikakulum's special economic zone (SEZ) in Andhra Pradesh on Thursday.
According to the compnay, the USFDA has made no observations after the inspection.
In April, the US drug regulator had inspected Dr Reddy's active pharmaceutical ingredients (APIs) manufacturing unit at the same SEZ plant in Srikakulam with no observations. After the inspection of yet another API facility at Srikakulam in the month of April, the USFDA had issued Form 483 after making two observations.
The USFDA issues Form 483 to a pharma company when it finds the firm guilty of violating the Food Drug and Cosmetic Act. The company should respond to the Form 483 with a corrective action plan and then implement it on an immediate basis.
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