Kenya attracts 13 new pharmaceutical manufacturers

Kenya has attracted 13 new pharmaceutical manufacturers that are at various stages of establishment and operationalisation, strengthening the country's efforts to expand local production of medicines and other health products. The new manufacturers are Med Aditus, Kenya Biovax Institute, Biopharma Limited in Gatundu-Thika, Full Care Limited, Tanatis Global Limited, Crown Healthcare, Regal Pharmaceuticals with its new penicillin plant, Spora International, Recon Health, the KEMRI Production Facility, Zuventus Limited, Aviazure Limited and Galaxy Pharmaceuticals. The companies are progressing through different stages of plant construction, equipment installation, quality-system development and regulatory readiness. Their entry signals growing investor interest in Kenya's pharmaceutical sector and its potential to serve both domestic and regional markets. The Pharmacy and Poisons Board (PPB) is providing regulatory guidance and technical support to facilitate the establishment of the facilities while ensuring that locally manufactured health products meet the required standards of quality, safety and efficacy. Amid onboarding of the manufacturers, PPB Chief Executive Officer Dr Ahmed Mohamed told The Standard that effective regulation is essential to building a competitive and trusted pharmaceutical manufacturing industry. "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," said Dr Mohamed. Dr Ahmed Mohammed, during an interview in his office. [Bernard Orwongo, Standard] Kenya imports an estimated 70 to 80 per cent of its health products and technologies, leaving the country vulnerable to disruptions in international supply chains. The Government has therefore prioritised domestic production, with a target of manufacturing at least 50 per cent of essential health products locally. Under the Pharmacy and Poisons Act, PPB regulates the manufacture, importation, distribution and use of health products and technologies. The Board is supporting both new and existing manufacturers through regulatory clinics, technical advisory meetings, capacity-building programmes and routine and risk-based Good Manufacturing Practice inspections. Manufacturers have received training on Good Manufacturing Practice requirements, pharmaceutical quality systems, dossier preparation, validation, qualification, data integrity and other regulatory expectations. PPB also conducts follow-up inspections and monitors corrective and preventive actions to promote continuous compliance and improvement. These interventions are intended to address regulatory and operational constraints that have limited the growth of local manufacturing. Stay informed. Subscribe to our newsletter