NAFDAC reopens Emzor, two others, stops production of codeine syrup

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Normal operations have resumed at Emzor Pharmaceuticals Industry Ltd, Lagos; Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State as the National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed that it has lifted the shutdown order on the three firms that were implicated in the codeine syrup crisis.

The Director-General of the Agency, Prof. Mojisola Adeyeye gave the directive in a statement on Saturday, following meetings between the companies and the agency’s directorates of Investigation and Enforcement, Drug Evaluation Research and Narcotics and Controlled Substances.

NAFDAC however, said the production of codeine syrup is to be stopped immediately until further notice while investigations continue.

The statement read, “The shutdown of the three companies has been lifted and the normal company operations can resume. However, the companies have been given the following sanctions:

“All production of codeine syrup should be stopped immediately until further notice. Therefore, the hold placed on the active pharmaceutical ingredient and the already made codeine syrups stands. NAFDAC will monitor the compliance.

“All codeine products are to be recalled and the process verified through audit trail verified by NAFDAC.”

The statement further said: “An embargo has been placed on new applications for permit or renewals for the importation of codeine as an active pharmaceutical ingredient for cough preparations, i.e., NAFDAC will not issue any permit until further notice

“The companies have been charged with administrative fees that are commensurate with the respective violations.”

NAFDAC said that it would hold a stakeholders meeting on the codeine crisis in a few days to develop a road map for the supply chain distribution and the future of codeine syrup manufacturing .

The agency also noted that the stakeholders meeting was in line with the Minister of Health pronouncements in his press release on the codeine crisis.

The agency had last week clamped down on the three companies due to their inability to provide required documents for NAFDAC officials during an inspection of their facilities on May 2 and 3 at Ilorin and Lagos.

The Federal Ministry of Health had recently directed NAFDAC to ban with immediate effect further issuance of permits for the importation of codeine as active pharmaceutical ingredient for cough preparations due to the gross abuse of codeine in the country.



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