Alembic Pharmaceuticals received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, on June 26, 2026. The approval allows the company to market a generic version of Hoffmann-La Roche Inc's Tamiflu Oral Suspension, targeting an estimated annual US market size of $27 million for the twelve months ending March 2026. This regulatory milestone strengthens Alembic's portfolio in the US generic pharmaceutical market.

The approved product is therapeutically equivalent to the reference listed drug Tamiflu Oral Suspension, 6 mg/mL. 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. It is also indicated for the prophylaxis of influenza A and B in patients one year and older.

Product Details and Indications

The drug 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. Key product details are outlined below:

Regulatory Approvals

Alembic Pharmaceuticals now holds a cumulative total of 243 ANDA approvals from the USFDA. This tally includes 223 final approvals and 20 tentative approvals. The company continues to expand its presence in the US market through the addition of new generic products to its portfolio.

Alembic Pharmaceuticals has scheduled a series of one-on-one meetings with institutional investors to discuss business updates and performance. The management will engage with representatives from HDFC Mutual Fund, Tata Mutual Fund, and DSP Mutual Fund through in-person sessions in Mumbai, followed by a virtual interaction with HDFC Life Insurance Company Limited. These meetings are part of the company's routine investor relations outreach to maintain transparency with key stakeholders.

The interactions are set to take place between June 22 and June 25, 2026. The first two meetings will be held physically in Mumbai, while the session with the insurance provider will be conducted via video conferencing. The company has explicitly stated that no unpublished price sensitive information will be shared during these discussions, ensuring compliance with regulatory norms.

Meeting Schedule

The following table details the scheduled investor interactions:

The disclosure was formally submitted to the stock exchanges on June 19, 2026. Manisha Saraf, Company Secretary of alembic pharmaceuticals , signed the intimation regarding these investor interactions.