Azelastine
Overview
Azelastine is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL639).
API suppliers (9)
Suppliers of Azelastine evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 5 of 9 suppliers.
3 of 9 hold a GMP certificate on record in the EU or UK registers
- Daito Pharmaceutical Co., LtdJapan1 active DMF
- ZHEJIANG LEPU PHARMACEUTICAL CO., LTD.China1 active DMF
- CORAL DRUGS PRIVATE LTD1 active DMF GMP on record
- Gedeon Richter Usa1 active DMF
- URQUIMA SA1 active DMF GMP on record
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
- Cipla USA, Inc.USA
- Jiangsu Hengrui Medicine Co., Ltd.China
- VIATRIS GMBH AND CO KG
Patent & exclusivity (US)
Per the FDA Orange Book (16 approved US products), the latest listed US patent on Azelastine expires 4 Jun 2028. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- 4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one
- Canonical SMILES
- CN1CCCC(CC1)N2C(=O)C3=CC=CC=C3C(=N2)CC4=CC=C(C=C4)Cl
- InChIKey
- MBUVEWMHONZEQD-UHFFFAOYSA-N
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