Alembic Pharmaceuticals Receives USFDA Final Approval for Oseltamivir Phosphate Oral Suspension
Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. This regulatory milestone positions Alembic in the competitive generic drug market following the approval of the ANDA.The approved product is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, manufactured by Hoffmann-La Roche, Inc. Oseltamivir Phosphate is utilized as an influenza neuraminidase inhibitor (NAI). The indications for this medication include 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, and prophylaxis of influenza A and B in patients one year and older.
Market projections indicate that Oseltamivir Phosphate for Oral Suspension, 6 mg/mL has an estimated market size of US$ 27 million for a twelve month period ending March 2026, according to IQVIA.
The successful approval adds to Alembic’s growing portfolio in the United States. The company reports that it holds a cumulative total of 243 ANDA approvals from the USFDA, which includes 223 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals Limited is described as a vertically integrated research and development pharmaceutical company with a history spanning back to 1907. Headquartered in India, Alembic manufactures and markets generic pharmaceutical products globally, maintaining state of the art research and manufacturing facilities approved by regulatory authorities including the USFDA.
APLLTD Stock Price Movement
Alembic Pharmaceuticals Limited shares slipped on Thursday, closing down 1.5% as they settled at ₹771.5. The stock traded within a wide range, hitting an intraday low of ₹765.1 during the trading session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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