 "Aurobindo Pharma receives 8 US FDA observations for two of its facilities")
Aurobindo Pharma on Wednesday said the US Food and Drug Administration (US FDA) had issued Form 483 with 4 observations each for two of its manufacturing facilities — Unit 5 API facility at Pashamailaram and Unit 8 API facility at Gaddapotharam in Hyderabad.
The company said the latest inspections by the US drug regulator were conducted from October 21 to 28 at the first facility, and from October 21 to 25 at the second. A similar inspection at Unit 4 formulations facility at Pashamailaram was currently under way, it said.
"We believe that these observations are related to procedural improvements and none of these relates to data integrity. The company will respond to the US FDA within the prescribed timelines," Aurobindo said in a filing.
One subscription. Two world-class reads.
Already subscribed? Log in
Subscribe to read the full story →*Subscribe to Business Standard digital and get complimentary access to The New York Times
Smart Quarterly
₹900
3 Months
₹300/Month
SAVE 25%
Smart Essential
₹2,700
1 Year
₹225/Month
SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months
Super Saver
₹3,900
2 Years
₹162/Month
Subscribe
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
SAVE 25%