In the midst of international pharmaceutical corporations leaving Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has revealed that 105 applications for the development of drug manufacturing facilities around the nation have been approved.
Selected from a pool of 143 submissions, these authorized applications comply with NAFDAC GMP for Medicinal Products Regulations 2021 and the World Health Organization’s Good Manufacturing Practice (GMP) principles.
NAFDAC’s Director General, Mojisola Adeyeye, states that 35% of the facilities that have been authorized have finished construction and are moving on with the registration process in accordance with NAFDAC’s criteria for the establishment of pharmaceutical plants.
Over 20 newly registered local drug manufacturers have collectively invested over $2 billion in erecting WHO-compliant facilities, representing a 12% increase in the number of active local manufacturers.
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NAFDAC sees these local efforts as a positive step forward for Nigeria amid the departure of global pharmaceutical giants such as GlaxoSmithKline (GSK) and Sanofi.
Emzor Pharmaceuticals Industries Limited is set to commence commercial manufacturing of four antimalarial Active Pharmaceutical Ingredients (APIs) following technical collaboration with NAFDAC and Indian-based WHO prequalified API manufacturers partners, Mangalam Drugs and Organics Limited.
Additionally, six local manufacturers are planning to initiate the local manufacture of various classes of widely used APIs and pharmaceutical excipients.
NAFDAC is actively involved in capacity building through an international workshop on Local Manufacturing of Active Pharmaceutical Ingredients and Excipients.
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The agency is preparing regulatory officers, manufacturers, students, and professors for a second workshop in the second quarter of 2024.
Swiss Pharma Nigeria Limited, one of Nigeria’s local manufacturers, recently had its pediatric formulation pre-qualified by the WHO, showcasing the growing global recognition of local products.
Other local drug producers and medical device manufacturers are also expressing interest in achieving global recognition.
Despite the challenges leading to the exit of multinational pharmaceutical companies, NAFDAC remains optimistic that with the right policies and regulatory environment, Nigeria can achieve self-sufficiency in the production of quality medicines that meet international standards.
The agency’s recent achievements, including attaining maturity three (ML3) status and WHO prequalification of the Central Drug Control Laboratory, signify efforts toward creating a stable and well-regulated manufacturing environment for essential medicines in Nigeria.
