# Alembic Pharmaceuticals Secures USFDA Final Approval for Ciprofloxacin and Dexamethasone Otic Suspension

> Alembic Pharmaceuticals received USFDA final approval for a generic equivalent to Sandoz's Ciprodex, targeting a $110 million market.

- Published: 2026-10-17T14:16:46+00:00
- Section: Regulation & Approvals
- Author: News Desk
- URL: https://newsforagent.com/news/2026-10-17/alembic-pharmaceuticals-usfda-otic-suspension-approval
- Source: [ScanX](https://scanx.trade/stock-market-news/companies/alembic-pharmaceuticals-secures-usfda-approval-otic-suspension/53790104)

## Key takeaways

- Alembic Pharmaceuticals received USFDA final approval for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%.
- The product is a generic equivalent to Sandoz Inc.'s Ciprodex Otic Suspension, targeting a $110 million market for the twelve months ending June 2026.
- Alembic now holds 246 cumulative ANDA approvals, comprising 226 final and 20 tentative approvals.

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%, according to [ScanX](https://scanx.trade/stock-market-news/companies/alembic-pharmaceuticals-secures-usfda-approval-otic-suspension/53790104). The approval allows the company to market a generic equivalent to Sandoz Inc.'s Ciprodex Otic Suspension in the United States, targeting a market estimated at $110 million for the twelve months ending June 2026.

## Alembic's Otic Suspension Approval and Market Opportunity

The approved formulation is indicated for treating infections caused by susceptible isolates of designated microorganisms. It addresses Acute Otitis Media in pediatric patients aged six months and older with tympanostomy tubes, as well as Acute Otitis Externa in pediatric, adult, and elderly patients aged six months and older. According to IQVIA data cited by ScanX, the estimated market size for this specific suspension was $110 million for the twelve months ending June 2026. The product is therapeutically equivalent to the reference listed drug manufactured by Sandoz Inc., positioning Alembic to compete directly in this established therapeutic segment. The approval adds to Alembic's portfolio of regulatory clearances in the US, bringing its cumulative total to 246 ANDA approvals. This portfolio comprises 226 final approvals and 20 tentative approvals.

## Alembic's ANDA Portfolio and US Market Position

Alembic Pharmaceuticals is a vertically integrated Indian pharmaceutical company that develops, manufactures, and markets generic formulations, APIs, and specialty medicines across India and more than 75 international markets including the US, according to akta.pro [company records](https://akta.pro/company-data). The same records state the company has 17,000 or more employees, nine manufacturing facilities, and 252 ANDA filings. The records also note that Alembic secured multiple USFDA final and tentative approvals through 2025-2026 across diverse therapeutic categories including oncology, ophthalmology, dermatology, neurology, and anti-infective, and that it achieved a US$250 million sales milestone in the US front-end by 2020.

## Earlier USFDA Inspections at Vadodara

In September 2026, Alembic Pharmaceuticals said the USFDA closed its inspection of its Vadodara bioequivalence facility, issuing an Establishment Inspection Report, CNBC TV18 reported. The inspection ran March 3-7, 2025, and the EIR will be released within 30 days. Earlier that month, The Times of India reported that Alembic Pharmaceuticals said the USFDA completed an unannounced inspection at its Vadodara bioequivalence facility with no observations. That inspection ran from August 31 to September 10, 2026, and concluded with no Form 483 observations.

## What Comes Next for Alembic

Alembic Pharmaceuticals will host one-to-one meetings with institutional investors and analysts in Mumbai on September 23, 2026, starting at 10:00 am, according to ScanX. The company said the discussions will rely exclusively on publicly available information.

## Companies in this story

- [ALEMBIC PHARMACEUTICALS LTD company profile](https://akta.pro/company-profiles/003uk1e/alembic-pharmaceuticals-ltd) · website: https://alembic-india.com

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