CDSCO Panel Asks Glenmark To Justify BE Waiver for FDC Inhalation Suspension With Scientific Evidence
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-07-05 10:06 GMT | Update On 2025-07-05 10:06 GMT
Glenmark
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has advised Glenmark Pharmaceuticals to furnish scientific backing for its request to waive a bioequivalence (BE) study for its proposed fixed-dose combination (FDC) inhalation suspension.
The firm presented its FDC—Glycopyrronium 100 mcg + Vilanterol 50 mcg + Fluticasone Furoate 200 mcg Inhalation Suspension—along with a request for BE study waiver at the SEC (Pulmonary) meeting held on 28th May 2025.
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