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Summary of the status of Natco Pharmas semaglutide with the CDSCO
Clinical trial approval The Subject Expert Committee SEC for Endocrinology and Metabolism recommended granting Natco permission to conduct Phase 3 clinical trials for its semaglutide solution for injection. This approval came after Natco submitted its bioequivalence study report and clinical trial protocol for type 2 diabetes and weight management.
Timeline
In an SEC meeting dated January 13, 2025, the committee recommended granting permission for the Phase 3 trial for weight management. Another meeting dated December 11, 2024, resulted in permission for a Phase 3 trial for type 2 diabetes.
Regulatory process Natco still needs to complete its Phase 3 clinical trials and submit the final results to the CDSCO for evaluation before it can receive permission to manufacture and market its generic version of semaglutide in India. We are probably 6 months away from getting final approval for marketing, if there are no glitches in the phase 3 trials currently underway. ( 225 days ago )
  prithvi111213  40 followers
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