Drug firm Aurobindo Pharma on Wednesday said it has received an establishment inspection report from the US health regulator with voluntary action indicated (VAI) status for its Unit-IV facility in Hyderabad.
The United States Food and Drug Administration (USFDA) had in November 2019 issued a Form 483 with 14 observations after the inspection of its Unit-IV, a general injectable formulation manufacturing facility situated at Hyderabad.
The regulator had inspected the facility from November 4 to November 13 last year, Aurobindo Pharma said.
"The company has received the establishment inspection report (EIR) with VAI status from USFDA," Aurobindo Pharma said in a regulatory filing.
According to the US health regulator, a VAI classification "means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action".
Shares of Aurobindo Pharma on Wednesday rose 20.40 per cent to close at Rs 602.25 per scrip on the BSE.
Disclaimer: No Business Standard Journalist was involved in creation of this content
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 →
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