Zydus Nesher Pharmaceuticals receives final approval from the USFDA
2019-07-19 · Zydus Lifesciences Limited · original zyduslife.com ↗
Zydus’ Nesher Pharmaceuticals receives final approval from the USFDA for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate ER Capsules Ahmedabad, 19 July, 2019 Zydus’ Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the USFDA to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, Extended- Release Capsules (US RLD – ADDERALL XR®), 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg. The drug is indicated for the treatment of Attention -Deficit Hyperactivity Disorder (ADHD) which is a brain disorder characterized by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development . It will be manufactured at Nesher Pharmaceuticals’ manufacturing facility located at St. Louis, MO, USA. The group now has 269 approvals and has so far filed over 360 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 23,000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020. ***
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