Lupin to Conduct BE Study for Synthetic Semaglutide Tablets in 3 Strengths
New Delhi: Lupin Limited has received the green light from the Subject Expert Committee (SEC) under the Endocrinology & Metabolism division of the Central Drugs Standard Control Organisation (CDSCO) to conduct a bioequivalence (BE) study for its synthetic Semaglutide Tablets in three dosage strengths - 3 mg, 7 mg, and 14 mg.
The proposal was reviewed at the SEC meeting following the company’s submission seeking permission to manufacture and market Semaglutide Tablets for the proposed indication. Lupin also presented the BE study protocol (Protocol No. 25-VIN-0292, Version 01, dated 16 May 2025) before the expert panel.
After detailed deliberations, the committee recommended granting permission to conduct the BE study as per the protocol presented. However, the SEC has stipulated that Lupin must submit the complete BE study report to CDSCO for further review by the committee before any marketing authorisation can be considered.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the management of type 2 diabetes mellitus. It improves glycaemic control by stimulating glucose-dependent insulin secretion, slowing gastric emptying, and reducing appetite. The synthetic variant refers to the chemically manufactured form of the drug substance.
