Alembic Pharmaceuticals Share Price in Focus; Receives USFDA Final Approval for Oseltamivir Oral Suspension

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. 

The approved product is therapeutically equivalent to Hoffmann-La Roche's Tamiflu Oral Suspension, 6 mg/mL.  

USFDA Grants Final ANDA Approval 

The approval covers Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. 

According to the company, the product is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Oral Suspension, 6 mg/mL, marketed by Hoffmann-La Roche, Inc.  

Indicated For Treatment and Prevention of Influenza 

Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI). 

indicated for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older who have been symptomatic for no more than 48 hours, as well as for the prophylaxis of influenza A and B in patients aged one year and older.  

USFDA Approval Portfolio Expands 

With this approval, Alembic Pharmaceuticals now has a cumulative total of 243 ANDA approvals from the USFDA. 

This includes 223 final approvals and 20 tentative approvals.  

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Alembic Pharmaceuticals Share Price Performance 

As of 25 June 2026,  Alembic Pharmaceuticals share price was closed at ₹771.50 per share, reflecting a decline of 1.17% from the previous trading session. 

Conclusion 

Alembic Pharmaceuticals has received USFDA final approval for its ANDA for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. The product is the generic equivalent of Tamiflu Oral Suspension and addresses an estimated U.S. market opportunity of US$27 million, while taking the company's cumulative USFDA ANDA approvals to 243.  

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