 "Bajaj Healthcare completes USFDA pre-approval inspection of Vadodara plant")
Bajaj Healthcare Ltd on Friday said it has successfully completed the US health regulator's pre-approval inspection of its active pharmaceutical ingredients facility located at Vadodara in Gujarat.
The US Food and Drug Administration (USFDA) had conducted a pre-approval inspection of the facility from November 14, 2022, to November 17, 2022, Bajaj Healthcare Ltd (BHL) said in a regulatory filing.
The pre-approval inspection of USFDA has completed successfully with zero Form 483 observations of the manufacturing facility, said the company, which is a manufacturer of APIs (active pharmaceutical ingredients), intermediates and formulations.
Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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