Exemed Pharmaceuticals gets CDSCO panel Nod To Manufacture, Market Antidiabetic Drug Imeglimin HCl SR Tablets
New Delhi: Based on the bioequivalence study report and Phase III clinical trial report of the antidiabetic drug Imeglimin hydrochloride presented by the drug major Exemed Pharmaceuticals, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to manufacture and market Imeglimin HCl sustained released Tablets 500 mg and 1000 mg for the indication “Treatment of Type 2 Diabetes Mellitus inadequately controlled with diet and exercise alone”.
This came after the firm presented the bioequivalence study report and phase III clinical trial report before the committee for the manufacturing and marketing of Imeglimin HCl SR Tablets 500 mg and 1000mg.
Imeglimin hydrochloride, an oral drug that oversees type 2 diabetes, brings down blood glucose levels. Among other overabundance impacts, it additionally supports mitochondrial DNA and movement while diminishing the making of responsive oxygen species (ROS).
Imeglimin is used in the treatment of Type 2 diabetes mellitus. Imeglimin works by stimulating insulin secretion in a glucose-dependent manner, which helps to lower blood sugar levels.
Imeglimin is used in the treatment of Type 2 diabetes mellitus. Imeglimin works by stimulating insulin secretion in a glucose-dependent manner, which helps to lower blood sugar levels
At the recent SEC meeting for Endocrinology and Metabolism held on the 19th and 20th of October 2023, the expert panel reviewed the bioequivalence study report and phase III clinical trial report of Imeglimin HCl SR Tablets 500 mg and 1000mg.
After detailed deliberation, the committee recommended the grant of permission to manufacture and marketing of Imeglimin HCl SR Tablets 500 mg and 1000 mg for the indication “Treatment of Type 2 Diabetes Mellitus inadequately controlled with diet and exercise alone”. However, the expert panel further suggested that the firm should fulfill the requirements of CMC data before approval of the product.
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