22:55 IST
NSE
Regulatory ApprovalCipla Ltd CIPLA
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.
Cipla regulatory approval announcements
Every Cipla regulatory approval announcement on NSE and BSE, newest first, each with its own page.
Time
3 announcements
09:48 IST
BSE
Regulatory ApprovalCipla Ltd CIPLA
Cipla Regulatory Approval
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.
16:30 IST
BSE
Regulatory ApprovalCipla Ltd CIPLA
Cipla Regulatory Approval
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.