Glenmark enters into exclusive distribution pact with Cediprof for FDA-approved products Health News, ET HealthWorld
Mumbai: Glenmark Pharmaceuticals Inc., USA, announced on Thursday that it has entered into an exclusive supply and distribution agreement with a Neolpharma Group company, cediprofInc.
The supply and distribution agreement is for US Food and Drug Administration ,FDA)-approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulphate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, the generic version of Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women’s Health, Inc.
The company said in a statement to the press that the product has been on the FDA’s shortage list for a long time. Glenmark expects to begin distribution of the product in the US during the second half of 2023.
Commenting on the launch, 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), 5 mg, 10 mg Glenmark is very pleased to be able to alleviate the shortage this country is facing by partnering with Cediprof and Neol.”
According to IQVIA sales data for the 12-month period ending January 2023, the Adderall tablet market at 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg achieved annual sales of approximately $389.8 million.
Glenmark’s current portfolio consists of 180 products authorized for distribution in the US marketplace and 48 ANDAs pending approval with the US FDA. In addition to these internal filings, the company claims it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.