Cipla Regulatory Approval
Cipla received U.S. FDA approval for its Generic Advair Diskus. The product is expected to launch in the U.S. market in Q2 FY 2026-27.
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Cipla received U.S. FDA approval for its Generic Advair Diskus. The product is expected to launch in the U.S. market in Q2 FY 2026-27.
Cipla's US subsidiary received final USFDA approval for the first AB-rated generic therapeutic equivalent of Ventolin HFA. The Albuterol Sulfate Inhalation Aerosol is expected to launch in H1 FY 2026-27, targeting a US market valued at $1.5 billion.
Cipla Limited announced the conclusion of a routine cGMP and Pre-Approval Inspection by the USFDA at its Goa facility. The inspection, conducted from April 6-17, 2026, resulted in two inspectional observations in Form 483. The company is committed to addressing these observations within the stipulated timeframe.