Exemed Pharmaceutical Gets CDSCO Panel Nod To Study Elobixibat Tablets 5mg
New Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a bio-equivalence study of the Elobixibat Tablets 5 mg.
This came after the firm presented the proposal for grant of permission to manufacture and market Elobixibat Tablets 5 mg along with the bioequivalence study protocol before the committee.
The committee noted that Elobixibat Tablets 5 mg were already approved for manufacture and market in India on 15-07-2024.
Elobixibat is used to treat chronic constipation and irritable bowel syndrome with constipation. It works by increasing the concentration of bile acids in the gut after eating, which stimulates bowel function. Elobixibat is a drug that treats chronic constipation by increasing the amount of bile acids in the colon, which stimulates bowel function.
At the recent SEC meeting for gastroenterology and hepatology held on 20th December 2024, the expert panel reviewed the proposal for grant of permission to manufacture and market Elobixibat Tablets 5 mg along with the bioequivalence study protocol.
After detailed deliberation, the committee recommended the grant of permission to conduct a bioequivalence study as per the protocol presented.
Accordingly, the expert panel suggested that the firm should submit the bio-equivalence study report to CDSCO for further review by the committee.
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