News | September 14, 2023
Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad
The inspection was a cGMP Inspection and had ended with NIL observations
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
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
The interaction with key Government Officials and industry leaders led to a joint exploration of possible collaboration and investments in the Healthcare ecosystem between the two countries
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
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