Custom Chemical Manufacture

Published December 2001

The manufacture of chemical entities by Custom Manufacturing Organizations (CMOs) is a $12 billion industry with a projected annual growth rate (AGR) of 8-10%. Growth in this segment of the Fine Chemicals Industry is being fueled by the pharmaceutical industry, both in the production of New Chemical Entities (NCEs) as well as the manufacture of generic drugs.

The decision to outsource the manufacture of a chemical entity versus building a dedicated facility for inhouse production requires an understanding of the differences between a singleproduct plant where, "The facility is designed for the process." and a multiproduct plant where, "The process is designed to fit the equipment in the facility."

In this report PEP evaluates the production of a chiral pharmaceutical intermediate, Lphenylalanine methylester hydrochloride, and the generic pharmaceutical, fluoxetine, in a dedicated plant versus outsourcing their production.

This report will be of interest to individuals responsible for outsourcing the manufacture of New Chemical Entities (NCEs) in the chemical and pharmaceutical industries as well as those organizations providing outsourcing services.