Drug Approval | September 09, 2024
Granules India’s Gagillapur facility completes USFDA inspection with six observations
The recent inspection covered both cGMP and PAI processes
The recent inspection covered both cGMP and PAI processes
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore
The sales of medicines and other items sold through Jan Aushadhi Kendras have increased from Rs. 7.29 crore in 2014 to Rs. 1,470 crore by July 2024
The inspection was concluded with two 483 observations
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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€ 6.6 million investment at Nantong site expands production capabilities for cell culture media
Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization
Renews GMP certifications for India and Malaysia sites
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