Drug firm Lupin Tuesday said the US health regulator has issued one observation after completion of inspection at its Tarapur facility in Maharashtra.
"The inspection closed with one observation, a procedural deficiency. The inspection at the site was conducted between August 27-31, 2018, by three U S Food and Drug Administration (USFDA) investigators," Lupin said in a regulatory filing.
The inspection focused on current good manufacturing practices (cGMP) compliance and also on the safety of Lupin's Valsartan, Losartan and Irbesartan APIs (commonly known as 'Sartans') in light of the safety alert issued by regulatory authorities on the NDMA (classified as a probable human carcinogen) impurity in Valsartan API supplied by some companies, it added.
Lupin said during the inspection, the USFDA concluded that the manufacturing processes of Lupin 'Sartans' are safe with no chance of presence of the NDMA impurity in the active pharmaceutical ingredients (APIs).
Shares of Lupin were trading 1.30 per cent lower at Rs 923 apiece on 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