USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
The company has received Form 483 with three observations
The company has received Form 483 with three observations
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
InvaGen has received 5 inspectional observations in Form 483
The inspection was a cGMP Inspection and had ended with NIL observations
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
The inspection closed with the facility receiving an inspection classification of NAI
The company will submit its comprehensive response on these observations to the US FDA
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
Construction will begin this year with the new capacity anticipated by 2025
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