Midazolam

Overview

Midazolam is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL655).

API suppliers (8)

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

• CAMBREX PROFARMACO MILANO SRLItaly2 active DMF GMP on record
• WAVELENGTH ENTERPRISES LTDIsrael1 active DMF GMP on record
• SUPRIYA LIFESCIENCE LTDIndia1 active DMF
• SOLARA ACTIVE PHARMA SCIENCES LTDIndia1 active DMF GMP on record
• GLOBAL CALCIUM PRIVATE LTDIndia1 active DMF GMP on record
• COHANCE LIFESCIENCES LTDIndia1 active DMF GMP on record
• ABBOTT LABORATORIES HOSP PRODUCTS DIV
• DIOSYNTH BV

EU CEP holders (7)

Companies holding a valid EU Certificate of Suitability (CEP) for Midazolam, 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 (40 approved US products), the latest listed US patent on Midazolam expires 20 Jun 2038 and exclusivity 17 May 2026. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine

Canonical SMILES

CC1=NC=C2N1C3=C(C=C(C=C3)Cl)C(=NC2)C4=CC=CC=C4F

InChIKey

DDLIGBOFAVUZHB-UHFFFAOYSA-N