Cadila Healthcare’s arm receives ANDA approval for Dextroamphetamine IR Tabs

Cadila Healthcare’s Nether Pharmaceuticals has received its first ANDA approval from the USFDA to market Dextroamphetamine IR Tabs. Nether Pharmaceuticals is a subsidiary of Zydus Pharmaceuticals USA. The drug falls in the CNS stimulant segment and is the first product to be developed by the R&D team at Nesher. The drug will be produced at the manufacturing facility based at St. Louis, Missouri, USA. The estimated sale for Dextroamphetamine IR Tabs is $40.6 mn as per IMS.

Nesher has considerable expertise in niche therapies which have development or production barriers, such as controlled release medications or DEA-controlled substances, which otherwise cannot be imported.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. It is the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia.