Pharmaceutical Exporter from India to Nigeria.

A complete Category-A dossier (ACTD/CTD format) with a clean GMP certificate and full stability data typically moves through NAFDAC in nine to fifteen months. Category-B molecules and those requiring full lab re-analysis run longer. We front-load the CPP, WHO-GMP, BMR, stability (ICH Zone IVb, 30°C/75%RH) and bioequivalence documentation so the first deficiency letter, if any, is answered within two weeks.

Yes. All narcotic, antimalarial and antibiotic packs destined for Nigeria ship with a scratch-panel MAS code applied at our partner plants before the container is sealed. The code maps to NAFDAC's 38353 SMS verification system, which pharmacists and patients query to confirm a pack is genuine. We reconcile issued codes batch by batch so the importer's reconciliation with NAFDAC stays clean.

For air cargo, Murtala Muhammed International (LOS) remains the primary hub; we also route into Nnamdi Azikiwe International (ABV) for Abuja-based consignees and occasionally Port Harcourt (PHC) for the Rivers and Bayelsa corridor. Sea consignments move through Tin Can Island or Apapa, with Onne used for oversize pharmaceutical-grade cargo. Cold-chain biologicals always route air into LOS.

No foreign manufacturer can bid directly. We bid through a NAFDAC-listed Nigerian distributor that holds the PCN wholesale licence. We produce the entire technical bid package, dossier extracts, registration certificates, CoA samples, price build-up and pro-forma, and the distributor files the bid. We ship against the awarded contract either on LC or, for state programmes, on secured open account.

First three consignments always move on an irrevocable LC at sight or 30 days, confirmed by an acceptable London- or Dubai-based bank. Once a payment track record is established, we convert to CAD or 60-day open account with credit-insurance backing through Afreximbank or ATI. NGO and donor-funded tranches settle against donor milestone releases, which we structure separately.

The last mile is the hard part. We pack insulin, oxytocin and paediatric vaccines in validated Envirotainer RAP e2 or Cool-Plus CRT passive shippers qualified for 72 to 120 hours at 2–8°C. Every shipment carries a dual temperature logger (Berlinger Q-tag and ELPRO) so the consignee has an auditable chart on arrival. Our Lagos 3PL holds cold-room buffer for onward splits to Ibadan, Enugu and Kano.

Both. We sell institutional volumes into LUTH, UCH Ibadan, ABUTH Zaria and other teaching hospitals via their NAFDAC-listed distributors, and we also move private retail SKUs through the PPMV and community-pharmacy channel using partners such as Emzor, Fidson-linked wholesalers and Pharma Deko for brands we have co-registered in Nigeria.

NAFDAC's NAPAMS e-Registration portal (NAFDAC Portal for Administration, Monitoring and Surveillance) is the mandatory submission channel since 2022. The legacy paper-dossier route is closed for new applications. The portal handles the full cycle: importer registration, product application, fee payment via Remita against the application number, eCTD or ACTD dossier upload (Module 1 country-specific, Modules 2-5 technical), reviewer assignment, deficiency-letter response (15 working days standard), and registration certificate issuance plus renewal scheduling. We prepare the eCTD baseline locally in Mumbai so the importer's portal upload is a one-pass file transfer, not a build-as-you-go upload that risks portal-timeout errors at the larger Modules 3 and 5 file sizes.

Yes for new sites, conditionally for established sites. NAFDAC operates an Overseas Manufacturer Inspection Programme under which inspectors travel to Indian (or other origin-country) plants for first-time registration of a high-risk molecule, biological, vaccine, antimalarial, antitubercular or oncology product. For molecules on the routine list at WHO-Prequalified sites or sites with a recent EU-GMP or US FDA inspection on the same product line, NAFDAC will accept the foreign inspection report in lieu of an own visit under its collaborative regulatory reliance approach. Inspection costs are borne by the importer or applicant. We coordinate the scheduling between NAFDAC headquarters and the Indian partner plant; typical lead time is three to six months from approval to inspection.

NAFDAC publishes its drug-registration fee schedule in Nigerian Naira and revises it periodically. Category-A drugs (new chemical entities or new combinations) carry the highest fee, Category-B drugs (existing molecules from a new manufacturer, or a new formulation of an existing molecule) sit at the mid tier, and Category-C drugs (line extensions, existing molecule from an existing manufacturer) at the lower tier. Vaccines, biologicals and biosimilars carry a separate fee schedule with additional lot-release charges per batch. We share the current Naira amounts at quote stage. Fees are paid through Remita against the application number, and the Remita receipt is uploaded back into the e-Registration portal as part of the application package.

NAFDAC categorises variations under the ICH-aligned framework: Type IA (notification-only, take effect immediately, file the notification within 12 months), Type IB (60 days for NAFDAC review, "tell, wait, do" if NAFDAC raises no objection), and Type II (major change, six to nine months including a formal review and possibly an updated inspection). Typical examples: pack-size change (Type IA), excipient supplier change with no specification impact (IB), specification change or manufacturing-site change (II). We file variations through the importer's e-Registration portal access using the same eCTD baseline format as the original registration, so the variation dossier reuses the source pack without retrofit cost.

NAFDAC's Pharmacovigilance and Post-Marketing Surveillance department mandates Adverse Drug Reaction reporting through the MedSafety Watch mobile app and the NAFDAC PV portal, plus Periodic Safety Update Reports (PSUR) submitted on the standard ICH cadence: every six months for the first two years post-registration, annual for the next two years, then three-yearly. We supply the manufacturer-side data (aggregate ADR signals, line-listings, signal-management summaries) in the WHO PIDM-compatible format. The importer's PV contact files the PSUR with NAFDAC under the local marketing authorisation, and we keep the source files versioned in Mumbai so the next cycle reuses the same baseline.