The drug maker on Wednesday announced that the United States Food and Drug Administration (US FDA) inspected its wholly owned subsidiary, APL Health Care's Unit I & III, at Jadcherla in Telangana, during 9 January to 18 January 2023.
In a regulatory filing, Aurobindo Pharma said that the US FDA has inspected its subsidiary, APL Health Care's Unit I & III, an orals (tablets, capsules and soft gel capsules) and derma manufacturing facility located at Jadcherla, Mahabub Nagar district, Telangana, from 9 January to 18 January 2023.
At the end of the inspection, The US drug regulator issued a 'Form 483' with 2 observations. The observations are procedural in nature, said the company.
We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observations at the earliest, the pharmaceutical company stated.
Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.
The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.
Shares of Aurobindo Pharma were up 0.35% to Rs 445.60 on the BSE.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
You’ve hit your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →
Quarterly Starter
₹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
Access to Exclusive Premium Stories Online
Over 30 behind the paywall stories daily, handpicked by our editors for subscribers
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