Memantine

As a neurodegenerative disease with a high incidence among the elderly population, Alzheimer's disease has long had very limited clinical treatment options, and the advent of memantine has provided an important intervention path for patients with moderate to severe Alzheimer's disease. As a non-competitive N-methyl-D-aspartic acid (NMDA) receptor antagonist, it can block neuronal damage caused by pathological elevation of glutamate concentration, improve patients' cognition, memory and daily living ability. It is a core therapeutic drug for moderate to severe Alzheimer's disease recommended by global guidelines at present, with the applicable population covering Alzheimer's disease patients at all stages from mild to severe, and it can also be combined with cholinesterase inhibitors to enhance treatment benefits.

The global number of Alzheimer's disease patients has exceeded 55 million, driving the continuous and steady growth of market demand for memantine. The global market size was approximately USD 1.8 billion in 2023, of which the Chinese market accounts for nearly 15%. With the successive launch of generic drugs after patent expiration, its market accessibility has been greatly improved. At present, more than 20 domestic preparation enterprises have passed the consistency evaluation, the winning bid price in centralized procurement has decreased by more than 90% compared with the original research drug, and the penetration rate in the primary market is increasing at an annual rate of about 8%, driving the continuous expansion of demand for upstream API.

Memantine was originally developed by Denmark's Lundbeck Pharma and Germany's Merck, with the brand name "Ebixa". Its core compound patent expired in 2010 in the European Union and the United States, and the compound patent expired in 2013 in China. The main dosage form of the original research drug approved in China is tablet, with specifications of 5mg and 10mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. At present, there are more than 30 registered DMF numbers of memantine API in China, and the approved and marketed preparations cover tablets, capsules, oral solutions and other dosage forms, which can fully meet the medication needs of different clinical scenarios. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of memantine impurity reference standards, covering all types of research reference materials such as process impurities and degradation impurities. Most products are regularly in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.