Thirteen pharmaceutical manufacturers are at various stages of establishing production facilities in Kenya, the Pharmacy and Poisons Board (PPB) has said, as the country pursues a target of manufacturing at least 50 per cent of essential health products domestically.
The named projects are Med Aditus, Kenya Biovax Institute, Biopharma Limited in Gatundu-Thika, Full Care Limited, Tanatis Global Limited, Crown Healthcare, Regal Pharmaceuticals through a new penicillin plant, Spora International, Recon Health, the KEMRI Production Facility, Zuventus Limited, Aviazure Limited and Galaxy Pharmaceuticals. They range across plant construction, equipment installation, quality-system development and regulatory preparation.
For distributors and procurement teams across East Africa, this is a forward view of where regional supply may come from over the next few years, and a shortlist worth tracking. Two entries carry particular weight: a dedicated penicillin plant addresses a category with chronic global supply fragility, and Kenya Biovax signals vaccine ambitions. But none of these facilities is producing at scale yet, and PPB gave no completion dates, capacities, product ranges or investment figures — so this is a pipeline, not available supply.
Kenya imports an estimated 70 to 80 per cent of its health products and technologies, exposing it to global supply disruption and price volatility in finished products and raw materials.
Dr Ahmed Mohamed, PPB chief executive, said regulatory predictability is what attracts the investment. “The entry of new manufacturers demonstrates growing confidence in Kenya’s pharmaceutical sector. Our responsibility is to provide a clear and predictable regulatory pathway that enables these investments to progress while ensuring that every locally manufactured product meets stringent standards of quality, safety and efficacy,” he said.
He was blunt about the limits of the current base. Kenyan production remains concentrated in importing and distributing, packaging and labelling, and manufacturing finished medicines, while output of active pharmaceutical ingredients and excipients is limited and those inputs are largely imported. “Our ambition must extend beyond packaging and producing finished medicines. Kenya needs to progressively develop the capacity to manufacture pharmaceutical ingredients and other critical inputs locally,” he said.
Manufacturers continue to face high utility and input costs, limited access to local bioequivalence testing and difficulty meeting WHO prequalification requirements. PPB says it is working towards clearer frameworks for local bioequivalence study centres and contract research organisations, and guiding manufacturers pursuing Good Manufacturing Practice certification and prequalification. Its support programme aims to raise utilisation of existing manufacturing capacity by 70 per cent and build capability in selected high-volume ingredients and excipients.
The Board is also pursuing WHO Global Benchmarking Tool Maturity Level 3 status for medicines and vaccines, which would place Kenya among the African regulators already recognised at that level and support access to regional and international procurement.
PPB did not state when any facility is expected to begin production, what products each will make, whether any has been inspected for GMP compliance, or the baseline against which the 70 per cent utilisation target is set.
Source: Statement by the Pharmacy and Poisons Board, and remarks by chief executive Dr Ahmed Mohamed.
