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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Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has...
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment of Hemophilia. Hemophilia is a genetic bleeding disorder caused by a dysfunction or deficiency of coagulation factor VIII or IX. Patients with this condition are...
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...
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
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has...
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment of Hemophilia. Hemophilia is a genetic bleeding disorder caused by a dysfunction or deficiency of coagulation factor VIII or IX. Patients with this condition are...
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...
