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.
After detailed deliberation, the SEC found the data acceptable and recommended granting permission for the manufacturing and marketing of the proposed FDC.
The approved FDC is intended for patients with type 2 diabetes mellitus, combining the SGLT2 inhibitory action of dapagliflozin with the insulin-sensitizing effects of pioglitazone. Such combinations are considered highly relevant for Indian diabetic patients who often require multi-drug regimens to achieve glycemic control.
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