Pharmaceutical Technology-09-01-2013

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

Commercial-scale amide formation and an improved process route for a tetracycline derivative are some recent developments in API synthesis.

A recent FDA guidance places greater attention on cocrystals as a tool in solid-dosage formulation.

The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.

A CMO perspective on the CMO-client partnership.

Industry experts share perspectives on risk assessment and mitigation in excipient manufacture and the excipient supply chain.