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Examples of APIs produced by chiral chromatography

There are many examples of the use of large-scale chiral chromatography to produce chiral APIs. Widely used in early development programs to rapidly prepare pure enantiomers for clinical programs, this technique is also well established for full development and commercial production of APIs. Some examples of APIs produced using chiral chromatography are shown in the table below.

Drug Name

Indication

Company

Phase

2008 World. Sales

Comments

Armodafinil

Nuvigil®

Narcolepsy, Jet lag disorder, obstructive sleep apnea and shift work sleep disorder

Cephalon

Marketed
in 2009

-

Large-scale chiral chromatography has been used to significantly reduce the time to market and produce launch quantities
More information

Escitalopram

Lexapro®

Depression, generalized anxiety disorder

Lundbeck

Marketed
in 2002

$1.24
billion

Currently produced by industrial chiral chromatography

Levitiracetam

Keppra®

Epilepsy

UCB

Marketed
in 1999

$1.75
billion

Currently produced by large-scale chiral chromatography
More information

Radafaxine

-

Restless leg syndrome, depression

GlaxoSmithKline

Discontinued

-

Thanks to the use of chiral chromatography for Radafaxine production, GSK was awarded twice for green chemistry
More information

AMG221

-

Type 2 diabetes

Amgen

Phase I

-

The shorter reaction
sequence and efficiency of the chromatographic separation make this route a more attractive option for long-term applications
More information

Pagoclone

-

Persistent developmental stuttering

Indevus Pharmaceuticals

Phase III

-

Chiral chromatography appeared to be the most time-efficient and cost-effective method in development
More information

 

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