News | May 15, 2023
Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute
Dr. Reddy's Laboratories has been issued a Form 483 with four observations
Dr. Reddy's Laboratories has been issued a Form 483 with four observations
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
The company has posted net profit of Rs.464.4 crores for the Financial Year ended March 31, 2023
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
The company is addressing these observations
The audit is a pre-approval inspection for three products filed from the facility
The observations are procedural in nature
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