Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the USFDA to market Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets in strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg.
The drug is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy and will be produced at the Nesher Pharmaceuticals’ manufacturing facility located at St. Louis, MO, USA. The sales of Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are estimated at $416.5 million. (Source: IMS Health, IMS National Sales Perspective Audit, MAT September 2017, extracted November 2017)
The group now has more than 165 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.
About Zydus Cadila
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 20000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020.