Last Updated on December 21, 2024 by The Health Master
USFDA approval
Alembic Pharmaceuticals, a leading global pharmaceutical company, has achieved a significant milestone with the US Food and Drug Administration approval (USFDA approval) for its Abbreviated New Drug Application (ANDA) for Albendazole Tablets USP, 200 mg.
This USFDA approval marks a crucial step in expanding the company’s global footprint and providing essential healthcare solutions to patients worldwide.
Key Highlights:
Therapeutic Equivalence:
Alembic’s Albendazole Tablets have been deemed therapeutically equivalent to the reference listed drug product (RLD), LAlbenza Tablets, 200 mg, manufactured by Impax Laboratories.
This ensures that patients can receive a high-quality, affordable alternative to the original brand-name medication.
Therapeutic Indications:
Parenchymal neurocysticercosis: A parasitic infection caused by the larval stage of the pork tapeworm, Taenia solium.
Cystic hydatid disease: A parasitic infection caused by the larval stage of the dog tapeworm, Echinococcus granulosus.
Cumulative USFDA Approvals: Alembic has now secured a total of 214 ANDA approvals from the USFDA, including 186 final USFDA approvals and 28 tentative approvals. This impressive achievement underscores the company’s commitment to innovation, quality, and regulatory compliance.
Expanding Global Reach
The USFDA approval of Albendazole Tablets further strengthens Alembic’s position as a trusted provider of generic pharmaceuticals in the US market.
By offering high-quality, affordable medications, the company is helping to improve access to essential healthcare for patients in need.
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