Drug firm Shilpa Medicare on Saturday said it has received two observations from the US health regulator for its Telangana facility.
The US Food and Drug Administration (USFDA) inspected the company's finished dosage formulation facility located at Pharmaceutical Formulations SEZ, APIIC, Jadcherla (Telangana state) from August 29 to September 6, 2019, Shilpa Medicare said in a filing to the BSE.
"The inspection concluded with two observations. There were no repeat observations or Data Integrity (DI) related observations," the company added.
Shilpa Medicare said the company is addressing these observations and will respond to the USFDA at the earliest.
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