News about Quality / GMP

French Court Orders Sanofi to Pay Euro 177 Million for Anti-Competitive Practices Over Plavix

A French court has ordered Sanofi to pay 177 million euro after ruling that the company engaged in anti-competitive behaviour to protect sales of its blockbuster blood thinner, Plavix. The decision follows a long-running investigation into allegations that Sanofi misled doctors and pharmacists about the safety of generic versions of the drug.

Quality / GMP | 25/09/2025 | By Darshana

ICMR and CDSCO Release First Set of 39 Standard IVD Evaluation Protocols

Standard In-Vitro Diagnostic (IVD) Evaluation Protocols, jointly developed by ICMR and CDSCO, include protocols for performance evaluation of IVD kits used for detecting tuberculosis, malaria, dengue, chikungunya, Zika virus, typhoid fever, various respiratory viruses, Chandipura virus, and Nipah virus.

Quality / GMP | 19/09/2025 | By Dineshwori |  102

India Now Among Top Global Reporters of Drug Adverse Events, Says DCGI

India has emerged as one of the top global contributors in reporting adverse drug events, according to Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI). He made the remarks during the inauguration of the 5th National Pharmacovigilance Week in New Delhi.

Quality / GMP | 18/09/2025 | By Darshana

NATCO Pharma's Kothur Facility Receives FDA EIR with VAI Classification

The US Food and Drug Administration (FDA) has completed an inspection at NATCO Pharma’s Pharma division located in Kothur, Hyderabad, India.

Quality / GMP | 18/09/2025 | By Dineshwori

AVITA Medical Receives CE Mark for RECELL GO

With the CE Mark secured, AVITA Medical will begin commercialisation of RECELL GO in select European countries, including Germany, Italy and the United Kingdom, in collaboration with burn centres and clinical partners.

Quality / GMP | 17/09/2025 | By Dineshwori

Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities

Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat.

Quality / GMP | 15/09/2025 | 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.

Quality / GMP | 13/09/2025 | By Dineshwori |  157

Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

The United States Food and Drug Administration (USFDA) has completed a general current Good Manufacturing Practices (cGMP) audit at Cohance Lifesciences' API manufacturing facility (API Unit1) located at Jaggaiahpet, Andhra Pradesh, with zero Form 483 observations.

Quality / GMP | 12/09/2025 | By Dineshwori

Sun Pharma Halol Facility Classified OAI by US FDA, Shipments Restricted

The US Food and Drug Administration (FDA) has classified Sun Pharma's Halol facility as “Official Action Indicated” (OAI) following an inspection conducted between June 2 and June 13, 2025.

Quality / GMP | 10/09/2025 | By Dineshwori |  189

Akums's Hormonal Plant Gets EAEU GMP Nod, Expands into Eurasia

Akums’s Hormonal Plant receives EAEU GMP certification for oral hormonal tablets, enabling entry into Eurasian markets with therapies for women’s health, HRT and endocrine care.

Quality / GMP | 09/09/2025 | By Dineshwori