 "Aurobindo Pharma's new injectable facility get 10 observations from US FDA")
Aurobindo Pharma announced on Sunday that the United States Food and Drug Administration (US FDA) has completed a Pre-Approval Inspection (PAI) at its new injectable facility in East Windsor, New Jersey. The inspection, conducted from December 11 to December 22, 2023, resulted in 10 observations.
The company reported that the observations are procedural and will be addressed within the stipulated timeframe. The facility, yet to start commercial operations, is operated by Eugia US Manufacturing LLC, a wholly-owned subsidiary of Aurobindo Pharma.
“The observations are procedural and will be responded to within the stipulated time,” the company stated in a regulatory filing.
On the same day, Aurobindo’s shares declined by 2.38 per cent on the Bombay Stock Exchange (BSE), closing at Rs 1,066 per share.
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 →*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%