Gaining Insights on Contract Chemical API Manufacturing An Industry Roundtable
Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.
Advancing API Synthesis
Commercial-scale amide formation and an improved process route for a tetracycline derivative are some recent developments in API synthesis.
Examining the Role of Cocrystals in Drug Development and Manufacturing
A recent FDA guidance places greater attention on cocrystals as a tool in solid-dosage formulation.
Coating and Taste Masking with Shellac
The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.
Optimizing Quality by Design in Bulk Powders and Solid Dosage
Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.
Making the Best of a Bad CMO-Client Relationship
A CMO perspective on the CMO-client partnership.
Risk Assessment of Excipients
Industry experts share perspectives on risk assessment and mitigation in excipient manufacture and the excipient supply chain.
