The National Agency for Food and medication Administration and Control (NAFDAC) has approved 105 applications for the creation of medication manufacturing facilities around the country, as international pharmaceutical companies leave Nigeria.
These accepted applications, chosen from a total of 143, follow the World Health Organization’s (WHO) Good Manufacturing Practice (GMP) requirements and the NAFDAC GMP for Medicinal Product Regulations 2021. According to Mojisola Adeyeye, Director General of NAFDAC, 35% of the approved facilities have completed construction and are in the process of being registered in accordance with NAFDAC’s pharmaceutical plant establishment criteria.
Over 20 newly registered local drug manufacturers have jointly invested more than $2 billion in building WHO-compliant facilities, representing a 12% increase in the number of active domestic producers. NAFDAC views these local efforts as a significant step forward for Nigeria in the wake of the exit of global pharmaceutical giants such as GlaxoSmithKline (GSK) and Sanofi.
Emzor Pharmaceuticals Industries Limited is ready to begin commercial production of four antimalarial Active Pharmaceutical Ingredients (APIs) following technical collaboration with NAFDAC and Mangalam Drugs and Organics Limited, an Indian-based WHO prequalified API manufacturer partner.
Furthermore, six local enterprises intend to begin local production of several types of widely used APIs and pharmaceutical excipient. NAFDAC is actively involved in capacity building by hosting an international workshop on local manufacturing of active pharmaceutical ingredients and excipients.
The agency is preparing regulatory officers, producers, students, and academics for a follow-up session in the second quarter of 2024. Swiss Pharma Nigeria Limited, one of Nigeria’s domestic producers, just received its pediatric formulation pre-qualified by the WHO, demonstrating the increasing global acceptance of local products.
Other local medicine and medical device manufacturers have expressed interest in obtaining worldwide reputation. Despite the problems that have led to the exodus of global pharmaceutical corporations, NAFDAC remains optimistic that with the proper policies and regulatory environment, Nigeria would be able to produce quality medications that meet international standards on its own.
The agency’s recent accomplishments, such as achieving maturity three (ML3) level and WHO prequalification of the Central Drug Control Laboratory, demonstrate efforts to establish a stable and well-regulated production environment for vital pharmaceuticals in Nigeria.
