Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. The approval was received on 17th October, 2026.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Ciprodex Otic Suspension, 0.3% / 0.1%, of Sandoz Inc.
Product Indication
Ciprofloxacin and Dexamethasone Otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions:
- Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes
- Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients
Market Size
According to IQVIA, the estimated market size for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%, was US$110 million for twelve months ending June 2026.
Cumulative Approvals
Alembic has a cumulative total of 246 ANDA approvals from USFDA, comprising 226 final approvals and 20 tentative approvals.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in India, operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide with state-of-the-art research and manufacturing facilities approved by regulatory authorities including USFDA. Alembic is one of the leaders in branded generics in India with a field force of over 5500.