Most manufacturing facilities that, at present, are capable of producing microbicides can only do so in limited volumes, which will be insufficient for widespread introduction. Furthermore, the facilities currently available are located in developed countries. Bringing production closer to the intended market – developing countries – may reduce distribution costs and regulatory burdens.

Previously, there was no comprehensive information on global options that the microbicide field could avail of for large-scale manufacturing. To fill this gap, IPM commissioned a survey of worldwide manufacturing capacity, with an emphasis on developing countries. This information has been captured in a database that will be made available to the microbicide field.

Approximately 250 companies were invited to participate in the survey. Those that were qualified as potential manufacturers of microbicide drug substance and product were then invited to undergo an extensive survey and/or an external audit of Good Manufacturing Practices to verify that its processes and facilities met international standards.

Over 110 companies provided contact information for the database and 20 companies in North and South America, Asia, and Africa completed the survey. Comprehensive audit reports have been assembled for a total of 17 companies who were qualified, and deemed capable of the development and commercial manufacture of the drug substance and formulations (e.g. gels, rings, tablets).

The survey concluded that although viable manufacturing resources are present in the developing world, they are relatively small in scale and hence need to be expanded.

For further information or to request a copy of the database, please contact Vimala Raghavendran at vraghavendran@ipm-microbicides.org or +1 301-608-2221.

>> View or download summary of 2007 IPM Worldwide Manufacturing Capabilities Survey [VR1] (pdf)