Glenmark and Cediprof announce exclusive distribution agreement in US for the ADHD drug

Glenmark Pharmaceuticals on Thursday said it has entered into an exclusive agreement with Cediprof Inc for supply and distribution in the US for the latter’s generic drug indicated for the treatment of attention deficit hyperactivity disorder.

The agreement entered between Glenmark Pharmaceuticals Inc USA and Cediprof Inc, a part of the Neolpharma Pharmaceutical Group family of companies, covers supply and distribution agreement for Cediprof’s FDA-approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablets of strengths 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, the company said in a statement.
These are the generic versions of Adderal tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women’s Health, Inc, it added.

Glenmark Pharmaceuticals said it expects to commence distribution of the product in the US during the second half of 2023. The drug is indicated for treatment of attention deficit hyperactivity disorder.

“This product has long been on FDA’s shortage list,” the company said.

Glenmark Global Formulations Business CEO Brendan O’Grady said the tablets which is a mixed salts of a single entity Amphetamine product is a highly prescribed medication in the US.

According to IQVIATM sales data for the 12-month period ending January 2023, Glenmark Pharmaceuticals said the Adderall tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market achieved annual sales of approximately USD 389.8 million.

More about Glenmark

Glenmark Pharmaceuticals is a global pharmaceutical company headquartered in Mumbai, India. The company was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient (API) manufacturer. Today, Glenmark has a presence in over 80 countries worldwide and has more than 15,000 employees.

Glenmark’s product portfolio includes branded and generic formulations, APIs, and biologics. The company focuses on therapeutic areas such as dermatology, respiratory, oncology, and cardiovascular diseases. Some of its well-known products include Candid and Momate in dermatology, and FabiFlu (Favipiravir) for the treatment of COVID-19.

Glenmark has a strong research and development (R&D) pipeline, with a focus on developing novel biologics and targeted therapies for the treatment of various diseases. The company has R&D centers in India, Switzerland, and the United States, and has collaborations with various academic institutions and biotech companies.

In addition to pharmaceuticals, Glenmark has a presence in the consumer healthcare segment through its subsidiary Glenmark Consumer Healthcare. The company’s vision is to become a leading global biopharmaceutical company that provides affordable and innovative medicines for patients worldwide.

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