Drug firm Wockhardt Thursday said it has received zero observations from the US health regulator after inspection of its bioequivalence centre at Aurangabad in Maharashtra.
The United States Food and Drug Administration (USFDA) carried out inspection of the bioequivalence centre located at R&D centre, Aurangabad from June 10 to June 12, 2019, Wockhardt said in a BSE filing.
During the inspection, bioanalytical and quality systems of bioequivalence studies of Tamsulosin 0.4 mg capsules and Metoprolol ER tablets were audited, it added.
"At the end of inspection, there was nil observation (i.e. zero 483 observation), signifying that best practices were followed, in compliance to regulations," Wockhardt said.
This outcome would lead approvals of abbreviated new drug applications (ANDAs) in pipeline for which bioequivalence studies are being or will be done in the said centre, it added.
Shares of Wockhardt Ltd closed at Rs 383.15 per scrip on BSE, down 1.12 per cent.
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