SEC Recommends Market Authorization for Elobixibat 5 mg Tablets by Exemed Pharma
New Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organization (CDSCO) has recommended market approval for Elobixibat 5 mg tablets, following the review of bioequivalence (BE) study data submitted by Exemed Pharmaceuticals.
The recommendation came during the 7th meeting of the SEC (Gastroenterology and Hepatology) held on 12th June 2025 at the CDSCO headquarters in New Delhi.
Earlier, the committee had advised the firm on 20th December 2024 to submit bioequivalence data. In line with this, the company presented the BE study report for Elobixibat 5 mg. The committee also acknowledged that the formulation had already received approval for manufacture and marketing in India on 15th July 2024.
After a detailed evaluation of the bioequivalence data, the committee found the results satisfactory and recommended final market authorization for the product, paving the way for its commercial rollout across India.
Elobixibat is a first-in-class ileal bile acid transporter (IBAT) inhibitor, indicated for the treatment of chronic idiopathic constipation (CIC). Unlike conventional laxatives, it works by increasing bile acid flow into the colon, thereby enhancing colonic motility and secretion. This novel mechanism offers an alternative treatment option for patients unresponsive to standard therapies.
Exemed Pharmaceuticals, headquartered in Gujarat, is an emerging Indian pharmaceutical company specializing in oral solid dosages. Its expanding portfolio includes both generic and specialty medicines targeting gastrointestinal, cardiovascular, and metabolic disorders.
