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News about "Pre-Approval Inspection "
Glenmark's Aurangabad Facility Clears US FDA Inspection With Zero Observations
Glenmark Pharmaceuticals announced that the US Food and Drug Administration (US FDA) has successfully completed a pre-approval inspection of its formulations manufacturing facility in Chhatrapati Sambhajinagar (Aurangabad).
Pre-approval Inspection | 01/12/2025 | By Dineshwori | 122
Lupin Receives EIR from US FDA for its Aurangabad (CSN) Facility
Lupin has received an Establishment Inspection Report (EIR) from the US FDA for its Aurangabad (CSN) facility, marking the successful closure of a product-specific Pre-Approval Inspection conducted between September 1 and September 5, 2025.
Pre-Approval Inspection | 14/11/2025 | By Dineshwori
Dr. Reddy's Biologics Facility in Hyderabad Receives USFDA Form 483 with Five Observations
The USFDA has completed a Pre-Approval Inspection (PAI) at Dr. Reddy's biologics manufacturing facility in Bachupally, Hyderabad, with five observations.
Pre-Approval Inspection | 13/09/2025 | By Dineshwori | 395
Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection
The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.
Pre-approval Inspection | 06/09/2025 | By Dineshwori | 794
Granules India Unit V Facility Completes US FDA Inspection with Zero 483 Observations
Granules India Ltd. has announced that the company’s Unit V facility has completed the US Food and Drug Administration (FDA) inspection between April 8-12, 2024, resulting in zero 483 observations.
Pre-Approval Inspection | 15/04/2024 | By Aishwarya | 911
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