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 regulator, Central Drugs Standard Control Organisation (CDSCO) has issued new directions for stringent controls on the supply chain of high-risk pharmaceutical-grade solvents. As per CDSCO directive dated 22 October, 2025, all high-risk Pharma grade solvent manufacturers shall obtain...
The USFDA has published a draft guidance updating scientific considerations for the use of comparative efficacy studies (CES) in demonstrating biosimilarity. The focus of the guidance is on therapeutic protein products. Building on experience gained since the April 2015 guidance...
Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in October, 2025. FDA had inspected the sterile formulation facility in June-July 2025 and made critical observations of cGMP deviations. The facility was acquired by Novo...
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 regulator, Central Drugs Standard Control Organisation (CDSCO) has issued new directions for stringent controls on the supply chain of high-risk pharmaceutical-grade solvents. As per CDSCO directive dated 22 October, 2025, all high-risk Pharma grade solvent manufacturers shall obtain...
The USFDA has published a draft guidance updating scientific considerations for the use of comparative efficacy studies (CES) in demonstrating biosimilarity. The focus of the guidance is on therapeutic protein products. Building on experience gained since the April 2015 guidance...
Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in October, 2025. FDA had inspected the sterile formulation facility in June-July 2025 and made critical observations of cGMP deviations. The facility was acquired by Novo...
