Nigeria Tightens API Sourcing Norms For Finished Pharma Products

Hyderabad: “Pharmaceutical companies and manufacturers must prioritise sourcing APIs from reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products,” Nigerian regulator National Agency for Food and Drug Administration and Control said, listing the approved sources and setting timeline for compliance.

While January 2024 was when the directive came into force for those submitting dossiers for product registration, companies with registered finished pharmaceutical products (FPPs) who have not sourced the APIs or excipients from listed sources are required to comply by January 2027, it said in a communication that Pharmaceuticals Export Promotion Council of India has circulated to its members.

Nigeria is 10th largest pharma export destination for India. Pharma exports to Nigeria increased 2.65% from $573.17 million in 2020-21 to $588.34 million in 2021-22. In 2022-23, it declined 12.30% to $515.96 million or 2.03% of the total pharma exports from India, Pharmexcil data shows.

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