Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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The Central Drugs Standard Control Organization (CDSCO) has issued a spurious drug alert for popular medications - Alkem’s Taxim-O (Antibiotic Cefixime), Pan D (Pantoprazole + Domperidone for acidity and indigestion), and Sun Pharma’s Rosuvas 10 (Rosuvastatin for lowering cholesterol). Samples...
In September 2024, the European Commission (EC) revoked the Conditional Marketing Authorisation (CMA) for Advanz Pharma’s Ocaliva (obeticholic acid), a second-line treatment for patients with primary biliary cholangitis (PBC). But the General Court of the European Union temporarily suspended the...
New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch drug products in US following critical deviations flagged by USFDA in the manufacture of drug products. The recall include more than 12 Million patches of...
We value your feedback on the Posts, Discussions, Information presented by Qvents. Also write to us on Pharma Quality and Regulatory topics and subjects you would like Qvents to cover. Your feedback helps us in making and maintaining the Qvents portal as a useful resource for Pharma TechOps professionals. Please also write to us for general feedback, quality of contents, any irrelevant or offensive posts, threads, comments
Please feel free to contact us for any enquiries.
Email: contact@qvents.in
Phone: (+91) 9945519525
We value your feedback on the Posts, Discussions, Information presented by Qvents. Also write to us on Pharma Quality and Regulatory topics and subjects you would like Qvents to cover. Your feedback helps us in making and maintaining the Qvents portal as a useful resource for Pharma TechOps professionals. Please also write to us for general feedback, quality of contents, any irrelevant or offensive posts, threads, comments
Please feel free to contact us for any enquiries.
Email: contact@qvents.in
Phone: (+91) 9945519525
The Central Drugs Standard Control Organization (CDSCO) has issued a spurious drug alert for popular medications - Alkem’s Taxim-O (Antibiotic Cefixime), Pan D (Pantoprazole + Domperidone for acidity and indigestion), and Sun Pharma’s Rosuvas 10 (Rosuvastatin for lowering cholesterol). Samples...
In September 2024, the European Commission (EC) revoked the Conditional Marketing Authorisation (CMA) for Advanz Pharma’s Ocaliva (obeticholic acid), a second-line treatment for patients with primary biliary cholangitis (PBC). But the General Court of the European Union temporarily suspended the...
New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch drug products in US following critical deviations flagged by USFDA in the manufacture of drug products. The recall include more than 12 Million patches of...
