The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, all directors, and every affiliated or associated person and entity found to have participated in regulatory violations.
The agency announced the sanction in a statement issued on Monday by its Director-General and Chief Executive Officer, Prof. Mojisola Adeyeye, stating that the decision takes immediate effect following investigations that uncovered multiple breaches of pharmaceutical regulatory requirements.
According to NAFDAC, the company was found to have engaged in regulatory misrepresentation, misuse of the agency’s approvals and certificates, improper registration and transfer of pharmaceutical products, and activities that circumvented established regulatory processes.
The agency said the violations compromised product traceability, weakened accountability, and posed significant risks to public health, contrary to the provisions of the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, the Drug and Related Products Registration Regulations 2021, and other applicable guidelines.
As a result, Onifam Laboratories, its Managing Director, directors, and all associated persons and entities have been prohibited from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC. The restriction includes applying for or benefiting from any NAFDAC registration, licence, permit, certificate, or approval, as well as acting as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters, or sponsors of any NAFDAC-regulated product in Nigeria.
NAFDAC added that the blacklist will remain in force until otherwise directed by its management, noting that it also reserves the right to impose further regulatory, administrative, enforcement, and legal sanctions where necessary to protect public health and preserve the integrity of Nigeria’s medicines regulatory system.
