The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd over multiple regulatory violations, with immediate effect.
The blacklist also covers the company’s Managing Director/Chief Executive Officer, all Directors, and all affiliated or associated persons and entities found to have participated in the violations.
The Director-General/Chief Executive Officer of NAFDAC, Mojisola Adeyeye, announced the sanction in a statement on Monday.
NAFDAC said the decision follows extensive investigations which established that the company engaged in regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and activities that circumvented established regulatory processes.
The agency said these actions compromise product traceability, weaken accountability, and pose significant risks to public health, in violation of the NAFDAC Act, the Food, Drug and Related Products (Registration, etc) Act, the Drug and Related Products Registration Regulations 2021, and other applicable regulatory guidelines.
“Consequently, the affected company and associated persons or entities are prohibited from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC.
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“This 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,” the statement said.
NAFDAC said the blacklist shall remain in force until otherwise directed by its management.
The agency said it reserves the right to take further regulatory, administrative, enforcement, and legal actions as necessary to safeguard public health and preserve the integrity of Nigeria’s medicines regulatory system.
NAFDAC reiterated its commitment to maintaining the highest standards of regulatory compliance and urged all stakeholders in the pharmaceutical sector to adhere strictly to applicable laws and regulatory requirements.
The agency said it remains resolute in ensuring that only safe, quality, and properly regulated medical products are available to the Nigerian public.
