Windlas Biotech Gets SEC Nod to Manufacture Dapagliflozin-Pioglitazone FDC
New Delhi: The Subject Expert Committee (SEC) for Endocrinology & Metabolism under the Central Drugs Standard Control Organisation (CDSCO) has granted manufacturing and marketing approval to Windlas Biotech Limited for a Fixed Dose Combination (FDC) of Dapagliflozin Propanediol Monohydrate equivalent to Dapagliflozin 10 mg and Pioglitazone Hydrochloride IP equivalent to Pioglitazone 15 mg in film-coated tablet form.
The proposal, submitted under file number FDC/MA/22/000315, was evaluated during the 10th/25th SEC meeting held on May 8, 2025, at CDSCO Headquarters, New Delhi.
Windlas presented raw data from its bioequivalence (BE) study, along with justification for pharmacokinetic variability, including individual and inter-subject differences. The data was reviewed by the expert panel in the presence of a clinical pharmacologist, as required for pharmacokinetic assessments.
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