PXL/HO/Cir-097/2023-24                                                                            Date: 12.02.2024

Hyderabad

Dear Sir/Madam,

Subject: Notification from NAFDAC Nigeria on “Quality of Active Pharmaceutical Ingredients (Apis) used in the manufacture of Finished Pharmaceutical Products (FPPS) for the Nigerian market”

We would like to bring to the kind notice of member exporters that NAFDAC, Nigeria has issued a notification on the supply of Active Pharmaceutical Ingredients (APIs) intended for the manufacture of Finished Pharmaceutical Products (FPPS) for the Nigerian market shall meet the following criteria,

In this context, NAFDAC notified all the stakeholders intending to submit dossiers for product registration starting from January 2024, that only applications supported by APIs or FPPs sourced from any of the under-listed approved sources will be accepted for review.

These are:

1.      WHO Prequalified APIs

2.      APIs with certificates of suitability to the monographs of the European Pharmacopoeia (CEP)

3.      APIs and FPPs sourced from facilities certified by PIC/S. participating Authorities.

4.      APIs sourced from facilities certified by Stringent Regulatory Authorities (SRA) or WHO

5.      Listed Authorities (WLA)

6.      APIs certified by accredited quality control laboratories.

Pharmaceutical companies and manufacturers must prioritize sourcing APIs from reputable Suppliers while adhering to stringent quality control measures to ensure the highest standards in their products. Furthermore, all excipients to be used in the manufacture of finished pharmaceutical products must be of pharmacopoeia grade, and must be from an ISO-9001:2015 or EXCiPACT-certified facility.

Companies with registered FPPs who have not sourced their APIs or Excipients from any of the listed sources, must provide evidence by January 2027 of a change of source to another manufacturer that satisfies any of the provisions listed above. The evidence must be submitted to the agency as a variation or post-approval change before the last day of January 2027.

For more information on the NAFDAC notification and its effective dates, please click here

With regards,

Uday Bhaskar
Director General