Amisulpride

Overview

Amisulpride is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL243712).

API suppliers (6)

Suppliers of Amisulpride evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• COSMA SPAItaly1 active DMF GMP on record
• ICROM SRLItaly1 active DMF GMP on record
• Zhejiang Huahai Pharmaceutical Co., Ltd.ChinaCEP GMP on record
• SYLACHIM
• Hubei Haosun Pharmaceutical Co., Ltd.China GMP on record
• ICROM SPA GMP on record

EU CEP holders (9)

Companies holding a valid EU Certificate of Suitability (CEP) for Amisulpride, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (2 approved US products), the latest listed US patent on Amisulpride expires 9 Feb 2038. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

4-amino-N-[(1-ethylpyrrolidin-2-yl)methyl]-5-ethylsulfonyl-2-methoxybenzamide

Canonical SMILES

CCN1CCCC1CNC(=O)C2=CC(=C(C=C2OC)N)S(=O)(=O)CC

InChIKey

NTJOBXMMWNYJFB-UHFFFAOYSA-N