 "FDC receives two observations from USFDA for Waluj plant")
Drug firm FDC Ltd has received two observations from the US health regulator related to current good manufacturing practice (cGMP) norms for its manufacturing facility situated at Waluj in Maharashtra.
The US Food and Drug Administration (USFDA) has completed the inspection of the company's manufacturing unit situated at Waluj on July 1, FDC Ltd said in a regulatory filing. “The USFDA has made two minor observations for which appropriate steps shall be taken by the company,” it added.
The USFDA carried out the audit of the facility in relation to cGMP norms and the abbreviated new drug application (ANDA) filed by the company for dorzolamide ophthalmic solution from the unit, it said. The company said it has also received the Establishment Inspection Report (EIR) from the USFDA for its manufacturing unit situated at Baddi, Himachal Pradesh with 'no observations'.
The receipt of EIR confirms the closure of inspection conducted in the facility in February this year.
The US Food and Drug Administration (USFDA) has completed the inspection of the company's manufacturing unit situated at Waluj on July 1, FDC Ltd said in a regulatory filing. “The USFDA has made two minor observations for which appropriate steps shall be taken by the company,” it added.
The USFDA carried out the audit of the facility in relation to cGMP norms and the abbreviated new drug application (ANDA) filed by the company for dorzolamide ophthalmic solution from the unit, it said. The company said it has also received the Establishment Inspection Report (EIR) from the USFDA for its manufacturing unit situated at Baddi, Himachal Pradesh with 'no observations'.
The receipt of EIR confirms the closure of inspection conducted in the facility in February this year.
"The said audit was carried out in relation to cGMP inspection and ANDA filed by the company for product Cefixime 400 mg tablet," the drug firm said.
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 →*Subscribe to Business Standard digital and get complimentary access to The New York Times
Smart Quarterly
₹900
3 Months
₹300/Month
SAVE 25%
Smart Essential
₹2,700
1 Year
₹225/Month
SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months
Super Saver
₹3,900
2 Years
₹162/Month
Subscribe
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
SAVE 25%