OTC Drug Registration for Foreign Manufacturers: What the FDA Requires Before You Can Sell in the US: Guide for Nigeria Exporters

Drug manufacturers in Nigeria, particularly in Lagos, Abuja, are increasingly targeting the US market. With key products such as sesame seeds, cocoa, cashew nuts, Nigeria has significant potential in the American market. However, to legally introduce products into the US, companies must strictly comply with US Food and Drug Administration (FDA) regulations. This article details the FDA requirements related to this topic for Nigeria businesses.

OTC drug monograph system and establishment registration

FDA regulations in this area apply to all foreign manufacturing facilities that wish to market products in the US. For drug manufacturers in Lagos and Abuja, compliance is not only a legal requirement but also a prerequisite for maintaining business relationships with US import partners. If requirements are not met, shipments can be held at the port, denied entry, or even placed on the FDA import alert list.

NDC Labeler Code and Drug Facts panel requirements

To export drug to the US, Nigeria companies need to: register their facility with the FDA, obtain a DUNS number from Dun & Bradstreet, appoint a US Agent with a US address, and ensure product labels comply with FDA regulations. For products such as sesame seeds, cocoa, cashew nuts, additional requirements may apply depending on the specific product type. FDABridge helps Nigeria companies complete the entire process.

FDABridge supports Nigeria exporters

FDABridge specializes in helping drug companies in Nigeria complete FDA registration from start to finish. Our services include consulting, DUNS number registration, US Agent provision, FDA facility registration filing, and periodic renewal. Contact us today at fdabridge.com to get started.