Glenmark enters into exclusive distribution pact with Cediprof for FDA-approved products, Health News, ET HealthWorld
FDA
)-approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate 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 Womens Health, Inc.
The company said in a statement to the press that the product has been on the FDAs shortage list for a long time. Glenmark expects to commence distribution of the product in the US during the second half of 2023.
Commenting on the launch, Brendan OGrady, 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, 15 mg, 20 mg, and 30 mg, 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."
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.
Glenmarks current portfolio consists of 180 products authorised 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.
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Thursday, March 9, 2023 at 5:35 am