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News about "Pre-Approval Inspection (PAI) "
Kemwell Biopharma’s drug-product manufacturing facility in Bengaluru has received clearance from the US Food and Drug Administration (FDA) for the commercial manufacturing and testing of injectable products intended for the US market, following the successful completion of a pre-approval inspection (PAI).
Pre-approval Inspection (PAI) | 29/10/2025 | By Dineshwori | 143
USFDA Concludes Inspection at Dr. Reddy's Srikakulam Facility with VAI Classification
Dr. Reddy’s Laboratories has announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) at its formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.
Pre-Approval Inspection (PAI) | 21/10/2025 | By Dineshwori | 281
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