Glenmark and Cediprof Announce Exclusive Distribution Agreement in the United States for US FDA Approved Mixed Amphetamines Immediate-Release Tablets
09 Mar 2023
Drug ApprovalLicense out/in
The Exclusive distribution agreement in the United States is for U.S. 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
MUMBAI, India and MAHWAH, N.J. and CAGUAS, Puerto Rico, March 9, 2023 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA and Cediprof, Inc. (a part of the Neolpharma Pharmaceutical Group family of companies) 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), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, the generic version of Adderall®1 Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women's Health, Inc. Glenmark expects to commence distribution of the product in the U.S. during the second half of 2023. This product has long been on FDA's shortage list.
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, 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® Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market2 achieved annual sales of approximately $389.8 million*.
Glenmark's current portfolio consists of 180 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is an innovation–driven, global pharmaceutical company with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world–class manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2021; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2021. Glenmark has impacted over 2.6 million lives over the last decade through its CSR interventions. For more information, visit www.glenmarkpharma.com. Follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma).
About Neolpharma Pharmaceutical Group:
Neolpharma Pharmaceutical Group engages in the research, development, production and marketing/distribution of generic medicines in the following therapeutic areas: CNS, oncology, metabolic disease, rheumatology and infectious diseases. Based in Mexico City, Mexico, Neolpharma Group has affiliates and operations in Puerto Rico, the U.S. and Latin America. For more information, visit the company's website at www.neolpharma.com.
References
1 All brand names and trademarks are the property of their respective owners.
2 Market includes brand and all available therapeutic equivalents
* IQVIA™ National Sales Perspectives: Retail & Non-Retail, January 2023
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SOURCE Glenmark Pharmaceuticals Ltd
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