Amisulpride

Schizophrenia is a severe mental disorder with high recurrence and high disability rates, and there is an urgent clinical demand for drugs that can improve both positive and negative symptoms. Amisulpride is a second-generation benzamide antipsychotic that exerts its effect by selectively blocking dopamine D2/D3 receptors in the limbic system. At low doses, it can improve negative symptoms (such as apathy and social withdrawal), while at high doses, it can effectively control positive symptoms such as hallucinations and delusions, and is less likely to cause extrapyramidal reactions. It is currently a first-line drug for the acute and maintenance treatment of adult schizophrenia, especially suitable for patients with poor tolerance to other antipsychotics.

The global market size of amisulpride maintains a steady growth trend, reaching approximately USD 1.28 billion in 2023. The sales volume at the terminal of Chinese public medical institutions exceeded RMB 1.8 billion, with a compound annual growth rate of around 7%. At present, the domestic market is co-populated by originator drugs and generic drugs, and amisulpride preparations from more than 15 enterprises have been approved for marketing. In the fifth batch of national centralized drug procurement in 2021, 4 generic manufacturers won the bid, with the bid price reduced by more than 70% compared with the originator drug, which greatly improved clinical accessibility and also drove the continuous rise in demand for upstream API.

The originator enterprise of amisulpride is Sanofi, with the original brand name "Solian". Its core compound patent expired in China in 2009. The main dosage form of the originator drug is tablet, with two specifications of 200mg and 400mg, which have been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA reference preparation catalogue. Up to now, more than 20 domestic enterprises in China have obtained CDE registration numbers (status A) for amisulpride API. The domestically approved amisulpride preparations cover multiple dosage forms such as tablets and dispersible tablets, which can fully meet clinical medication needs. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for amisulpride API. The products strictly comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations. Most products are available in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. It can provide reliable reference material support for the whole process of quality research, registration and declaration, stability study, etc. of API and preparation manufacturers.