News about Quality / GMP

Piramal Pharma Solutions' Grangemouth Facility Receives Updated MHRA GMP Certificates

Piramal Pharma Solutions's Grangemouth facility in the UK has received updated MHRA GMP certificates following a successful compliance report and desktop inspection.

Quality / GMP | 19/11/2025 | By Dineshwori

Alembic Pharmaceuticals Receives USFDA Final Approval for Diltiazem Hydrochloride Tablets

Alembic Pharmaceuticals has received final approval from the USFDA for its Diltiazem Hydrochloride Tablets in multiple strengths, a generic version of Cardizem used for managing certain types of angina. The approval adds to the company’s growing US portfolio, bringing its total ANDA count to 230, including 210 final and 20 tentative approvals.

Quality / GMP | 18/11/2025 | By Dineshwori

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

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 |  104

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

Kemwell Biopharma's Bengaluru Facility Secures US FDA Clearance for Commercial Manufacturing of Injectable Products

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 |  100

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 |  213

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 |  117

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).
<br />

Quality / GMP | 15/10/2025 | By Dineshwori |  109

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 |  255