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).
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