Drug Approval | July 08, 2022
Dr. Reddy's Laboratories updates on PAI of formulations facility
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
The US FDA had conducted an inspection of Alkem Laboratories Limited's manufacturing facility located at St. Louis, USA.
Dr Rupali Paranjape, an experienced regulatory and compliance consultant and author of Blue Ocean of Compliance shares insights on her book in an interview with Thomas C Thottathil, Editor, www.indianpharmapost.com
A total of five observations for Goa and 17 for Monroe
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
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