Glenmark Pharmaceuticals Inc., USA, (BSE:532296) (NSE:GLENMARK), a subsidiary of India-based Glenmark Pharmaceuticals, and Cediprof, Inc, a part of the Mexico-based Neolpharma Pharmaceutical Group family of companies, announced on Thursday that they have entered into an exclusive supply and distribution agreement for Cediprof's FDA-approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5mg, 10mg, 15mg, 20mg and 30mg, the generic version of Adderall Tablets, 5mg, 10mg, 15mg, 20mg, and 30mg, of Teva Women's Health, Inc.
Glenmark expects to commence distribution of the product in the US during the second half of 2023. This product has long been on FDA's shortage list.
Brendan O'Grady, chief executive officer – Glenmark Global Formulations Business said, 'Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5mg, 10mg, 15mg, 20mg and 30mg is a highly prescribed medication in the United States. Glenmark is very pleased to be able to alleviate the shortage this country is facing by partnering with Cediprof and Neol.'
Lupin Pharmaceuticals launches Tiotropium Bromide Inhalation Powder, 18mcg/capsule in US
Aurisco announces Yangzhou, China manufacturing site's successful FDA inspection
Teva Pharmaceuticals and Alvotech expand biosimilars partnership in the US
Sandoz to invest USD90m in Biosimilar Technical Development Center in Slovenia
Brenzavvy Now Available for the Treatment of Adults with Type 2 Diabetes
Dr. Reddy's Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA
Dr. Reddy's rituximab biosimilar candidate undergoes regulatory review in the US, EU and UK
Grossman Named President and Chief Medical Officer at Coya Therapeutics
Endo International launches first generic version of Merck's Noxafil