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EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome
The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.
Quality / GMP | 17/11/2025 | By Dineshwori | 298
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 | 351
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 | 1259
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 | 494
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 | 520
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 | 296
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 | 443
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 | 568
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 | 434
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 | 228
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