CDSCO panel tells Glenmark to provide in-vivo data, global data concerning Pulmonary FDC in inhalation suspension
In reaction to the request for a waiver of bioequivalence (BE) and Phase III clinical trials for the inhalation suspension of the pulmonary drug combination Glycopyrrolate, Formoterol Fumarate Dihydrate, and Budesonide (25mcg+20mcg+500mcg), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Glenmark Pharmaceuticals to provide both in-vivo study data and global data concerning the Fixed-Dose Combination (FDC) in Inhalation Suspension dosage form.
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