Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. According to reports from Business Standard, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche Inc. The approval was granted on June 26, 2026, as confirmed by TradingView News citing Thomson Reuters reports. This regulatory milestone allows Alembic to market a generic version of the product, targeting an estimated annual US market size of $27 million for the twelve months ending March 2026. As per the latest regulatory filing submitted to the National Stock Exchange of India (NSE), this approval marks a significant achievement for the company.
Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for the treatment of acute, uncomplicated influenza A and B in patients two weeks of age and older who have been symptomatic for no more than 48 hours. According to Business Standard, the drug is also indicated for the prophylaxis of influenza A and B in patients one year and older. The approved product is specifically used for the treatment of acute, uncomplicated influenza in pediatric and adult patients, provided treatment starts within 48 hours of symptom onset. Additionally, it serves as a prophylactic measure for influenza A and B in patients aged one year and older. This approval expands Alembic's portfolio in the infectious disease segment, providing a treatment option for influenza, a significant public health concern.
Alembic Pharmaceuticals maintains a cumulative total of 243 ANDA approvals from the USFDA, comprising 223 final approvals and 20 tentative approvals. According to the company's regulatory disclosure, this latest approval strengthens their position in the US generics market with a robust approval portfolio. The approval adds to Alembic's growing list of cleared generic products, demonstrating the company's consistent capability in navigating the complex regulatory landscape for generic drugs. This achievement underscores Alembic's commitment to expanding its portfolio of generic pharmaceutical products in the global market.
Alembic Pharmaceuticals Limited, established in 1907, operates as a vertically integrated research and development pharmaceutical company headquartered in Vadodara, India. The firm manufactures and markets generic pharmaceutical products globally, with research and manufacturing facilities approved by regulatory authorities in several developed countries, including the USFDA. The company is recognized as a leader in branded generics in India, supported by a field force of over 5,500 personnel. As per the latest regulatory filing, Alembic is publicly listed and known for manufacturing and marketing generic pharmaceutical products worldwide, with its brands being well recognized by doctors and patients.
