Raising the Technological Level: The Scope for API, Excipients, and Biologicals Manufacture in Africa
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This chapter discusses raising the technological scope for locally manufacturing active pharmaceutical ingredients (APIs), excipients and biologicals in Africa — a hitherto nascent industry. It also discusses African drug development and manufacturing through the standardized use of ‘reverse pharmacology’ to bring new treatments for neglected diseases to the point of regulatory approvals. Currently there is very modest production of APIs on the African continent, although a few significant projects exist,1 (such as LaGray in Ghana and Fine Chemicals in South Africa), or are in the planning stages.2 Generic producers in India and China supply nearly all of the APIs used in African pharmaceutical manufacturing. Most African companies cannot afford the heavy investment and research and development activities required for API production.
KeywordsTenofovir Disoproxil Fumarate Good Manufacturing Practice Technological Level Quality Management System Pharmaceutical Manufacturing
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