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Lupin Receives EIR from US FDA for its Pithampur Unit-3 Facility
Following an inspection in July 2025, Lupin received the USFDA’s Establishment Inspection Report (EIR) for its Pithampur Unit-3 facility.
Quality / GMP | 06/11/2025 | By Dineshwori | 314
Kwality Pharma Receives EU-GMP Certification for Amritsar Units
Kwality Pharmaceuticals has announced the successful completion of the European Union Good Manufacturing Practices (EU-GMP) audit at its Amritsar manufacturing facilities, covering both the general and beta-lactam units.
Quality / GMP | 06/11/2025 | By Dineshwori | 635
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).
Quality / GMP | 29/10/2025 | By Dineshwori | 401
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.
Quality / GMP | 21/10/2025 | By Dineshwori | 449
Biocon's Cranbury Facility in US Passes FDA Inspection, Supports Expansion Plans
Biocon’s inspection concluded with a single observation, which the company will address within the stipulated timeframe, and it is not expected to impact ongoing business operations
Quality / GMP | 15/10/2025 | By Dineshwori | 257
Vasa Therapeutics Receives FDA IND Clearance to Advance Novel Small Molecule VS-041
Vasa Therapeutics plans to immediately initiate a phase-I (c) clinical trial in the US for participants with Heart Failure with Preserved Ejection Fraction (HFpEF).
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Quality / GMP | 15/10/2025 | By Dineshwori | 337
US FDA Completes Pre-Approval Inspection at Lupin's Somerset Facility with One Observation
The US Food and Drug Administration (FDA) has completed a pre-approval inspection of Lupin’s manufacturing facility in Somerset, New Jersey, USA, with one observation.
Quality / GMP | 11/10/2025 | By Dineshwori | 514
CDSCO Launches Nationwide Inspections of Drug Manufacturing Units After Cough Syrup Deaths
The Central Drugs Standard Control Organisation (CDSCO) has initiated risk-based inspections of drug manufacturing units in six Indian states following reports of child fatalities linked to contaminated cough syrups.
Quality / GMP | 06/10/2025 | By Darshana | 410
Following reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, the Union Health Ministry has directed all pharmaceutical manufacturers to strictly comply with the Revised Schedule M for Good Manufacturing Practices (GMP).
Quality / GMP | 06/10/2025 | By Dineshwori | 201
US FDA Classifies Lupin's Pithampur Unit-2 as Official Action Indicated
The US Food and Drug Administration (FDA) has concluded its inspection of Lupin’s Pithampur Unit-2 manufacturing facility, issuing a Form 483 with four observations.
Quality / GMP | 04/10/2025 | By Dineshwori | 590
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