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Drug maker, Cadila Healthcare Limited (Zydus CAdila) on Wednesday informed that Nesher Pharmaceuticals, an arm of Zydus Pharmaceuticals USA has received its first Abbreviated New Drug Application (ANDA) approval from the US drug regulator, USFDA to market Dextroamphetamine IR Tabs.
In a statement issued here, the company said, 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 sales for Dextroamphetamine IR Tabs is US $ 40.6 million 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, it added.
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