ALEMBIC PHARMA : RECEIVES USFDA FINAL APPROVAL FOR CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION

• Final USFDA approval for ANDA of Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1% • Approved ANDA is therapeutically equivalent to reference listed drug Ciprodex Otic Suspension of Sandoz Inc. • IQVIA estimated market size for the product at US$110 million for twelve months ending June 2026 • Indicated for acute otitis media in pediatric patients with tympanostomy tubes and acute otitis externa across age groups • Cumulative ANDA approvals now 246 (226 final and 20 tentative)

Alembic Pharmaceuticals Ltd

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