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Codeine Syrup: NAFDAC Lifts Shutdown Of Emzor, Two Others

The National Agency for Food and Drug Administration and Control (NAFDAC) has lifted the shutdown it earlier ordered on three pharmaceutical companies over the codeine syrup scandal.

The companies include Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor Pharmaceuticals Industry Limited.

NAFDAC in a statement signed on Saturday by the Director General, Professor Mojisola Adeyeye, said this decision was reached after meeting of high-powered executives of the companies that were implicated in the codeine syrup distribution.

“The three companies cooperated with NAFDAC during the meeting, provided the needed documents, some of which are being verified. 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,” the statement read in part.

Adeyeye gave the directive for the meetings to be held with the companies following NAFDAC directorates – Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS) who led the meeting.

NAFDAC had separate meetings with the companies – Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State, and Emzor Pharmaceuticals Industrial Limited, Lagos.

The sanctions given to the companies ordered that all production of codeine syrup should be stopped immediately until further notice. It also instructed that an hold should be placed on the active pharmaceutical ingredient and the already made codeine syrups stands.

Also, all codeine products are to be recalled and the process verified through audit trail verified by NAFDAC.

“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,” the statement read further.

NAFDAC said a stakeholders meeting on the codeine crisis will also be held to develop a road map for the supply chain distribution and the future of codeine syrup manufacturing, in line with the Minister of Health, Issac Adewole’s pronouncements in his press release on the codeine crisis.

Tags: BIORAJ, codeine, Emzor, NAFDAC






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Posted by Phresh On May 12, 2018

Categories: News


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