The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Aurobindo will respond to the US FDA within the stipulated timelines
The company will submit its comprehensive response on these observations to the USFDA
Dr. Reddy's Laboratories has been issued a Form 483 with four observations
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
The observations are procedural in nature
Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.
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