Alembic Pharmaceuticals Ltd has secured final approval from the US Food & Drug Administration (USFDA) for its Albendazole Tablets USP, 200 mg. This approval is for the company’s Abbreviated New Drug Application (ANDA), and the tablets are therapeutically equivalent to the reference drug, Albenza Tablets, 200 mg, from Impax Laboratories.
Albendazole tablets are used to treat neurocysticercosis caused by the pork tapeworm and cystic hydatid disease of the liver, lung, and peritoneum caused by the dog tapeworm. Alembic now has a total of 214 ANDA approvals, including 186 final approvals and 28 tentative approvals, from the USFDA.
Founded in 1907 and headquartered in India, Alembic Pharmaceuticals is a prominent player in the global generic pharmaceutical market. The company is known for its research and manufacturing excellence, with facilities approved by regulatory authorities, including the USFDA.
