Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3%/0.1%. The approved product is therapeutically equivalent to Ciprodex Otic Suspension, 0.3%/0.1%, the reference listed drug marketed by Sandoz Inc. The approval expands Alembic’s portfolio of generic pharmaceutical products for the US market.
Ciprofloxacin and Dexamethasone Otic Suspension is indicated for the treatment of certain ear infections caused by susceptible microorganisms. These include acute otitis media in paediatric patients aged six months and older who have tympanostomy tubes, and acute otitis externa in paediatric patients aged six months and older, adults and elderly patients. Patients and healthcare professionals should refer to the approved product labelling for complete indications and usage information.
According to IQVIA data cited by the company, the US market for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3%/0.1%, was estimated at US$110 million for the 12 months ended June 2026. With this approval, Alembic Pharmaceuticals has received a cumulative total of 246 ANDA approvals from the USFDA. These comprise 226 final approvals and 20 tentative approvals, reflecting the company’s ongoing participation in the US generic medicines market.
Alembic Pharmaceuticals is a research and development-focused pharmaceutical company with an integrated manufacturing and research infrastructure. Established in 1907 and headquartered in India, the company manufactures and markets generic medicines in India and international markets.
Its research and manufacturing facilities have approvals from regulatory authorities in several developed markets, including the USFDA. The company also has a presence in India’s branded generics segment, where its products are marketed through a field force of more than 5,500 employees.
The latest approval adds another product to Alembic’s US portfolio as it continues to develop and seek regulatory clearance for generic medicines. The company operates across research, product development, manufacturing and marketing, serving healthcare markets in India and overseas.
The USFDA’s final approval confirms that the application for the generic otic suspension has met the relevant regulatory requirements for approval. Alembic’s cumulative approvals reflect its continuing efforts to expand its product offerings and serve demand for generic medicines in the United States.
Alembic Pharmaceuticals Limited is one of India’s oldest and most respected pharmaceutical companies, with a legacy that dates back to 1907. Headquartered in India, Alembic has built a strong global presence as a vertically integrated research-driven pharmaceutical company, focused on the development, manufacturing and marketing of high-quality generic medicines. The company operates across major therapeutic areas and supports healthcare systems worldwide through a wide portfolio of affordable formulations and active pharmaceutical ingredients.
A key strength of Alembic is its strong emphasis on research and development, backed by modern infrastructure and a consistent pipeline of new products for regulated and emerging markets. Its manufacturing facilities meet global standards and are approved by leading regulatory authorities, including the US Food & Drug Administration (USFDA). The company has secured a significant number of ANDA approvals in the United States, reflecting its capability in compliance-driven product development and execution.
