Akum Gets CDSCO Panel Nod to Manufacture, Market Glimepiride, Lobeglitazone FDC
New Delhi: The drug major Akum Pharmaceuticals has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination (FDC) of the antidiabetic drug Glimepiride plus Lobeglitazone sulfate tablet.This came after the firm presented the bioequivalence (BE) study report of the...
New Delhi: The drug major Akum Pharmaceuticals has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination (FDC) of the antidiabetic drug Glimepiride plus Lobeglitazone sulfate tablet.
The committee noted that the firm has already conducted the BE study and considered the results of the BE study and the justification for Phase III CT Study waiver at this stage.
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