Blockbuster MDI and DPI products have usually been brought to market by large pharmaceutical companies who have in-house capabilities in every aspect of product development, industrialization and supply.
As these products approach the end of the exclusivity afforded them by intellectual property rights, smaller development companies (developers) have emerged. These companies focus on gaining a share of this lucrative market, for example by developing a competing new drug delivery device or by using new approaches to formulating active ingredients, administered as either a dry powder inhaler (DPI) or pressurized metered dose inhaler (MDI).
When such companies progress toward late stage development and manufacturing of commercial quantities, there can be a need to look beyond their in-house resources to Contract Manufacturing Organizations (CMOs) with the appropriate capabilities to help them successfully manufacture their products. CMOs of various types are available, including large pharmaceutical companies.