Progene Pharma

Country · Africa

Pharmaceutical exports to Nigeria, ready for NAFDAC registration

Progene Pharma supplies Nigerian importers, wholesalers, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples NAFDAC asks for, pack for Nigeria's heat and humidity, and ship to Lagos, Port Harcourt and Abuja.

Regulator
NAFDAC
Labels
English, with the NAFDAC number
Stability
Zone IVb, 30 °C / 75% RH
Main ports
Apapa, Tin Can, Lekki, Onne

The Nigerian medicines market in brief

Nigeria is the most populous country in Africa and the largest pharmaceutical market in West Africa. It imports most of the medicines it uses, and demand is steady across public hospitals, private pharmacies, patent medicine vendors and national disease programmes.

The disease burden shapes what sells. Nigeria carries about a quarter of the world's malaria cases, so antimalarials are among the highest-volume products. Antibiotics, painkillers and medicines for HIV and tuberculosis follow, and diabetes and high blood pressure now account for a growing share of prescriptions in the cities.

Buyers range from large importers who supply wholesale markets in Lagos, Onitsha and Kano, to hospital suppliers and companies that bid for federal and state tenders. What they share is a need for products NAFDAC has registered, packs that survive the climate, and a manufacturer that answers the regulator's questions.

Medicines we supply to Nigeria

These are the medicines Nigerian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations

  • Antimalarials

    Artemether and lumefantrine tablets, dispersible tablets and dry syrup, artesunate injection and artesunate and amodiaquine, for pharmacies, clinics and malaria programmes.

  • Antibiotics

    Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, in adult and paediatric forms.

  • Pain and fever

    Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections, the fastest-moving products in most pharmacies.

  • HIV and tuberculosis

    Antiretrovirals such as lamivudine and zidovudine, and rifampicin, isoniazid, ethambutol and pyrazinamide, for national programmes and treatment centres.

  • Diabetes and blood pressure

    Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become more common in Lagos, Abuja and other cities.

  • Deworming and child health

    Albendazole for school deworming, and oral rehydration salts with zinc for children with diarrhoea.

  • Mother and child health

    Iron with folic acid for pregnancy, vitamin B complex, vitamin D3 and paediatric syrups.

  • Hospital supplies

    IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital and tender packs.

NAFDAC registration, step by step

A medicine cannot be imported, advertised or sold in Nigeria until NAFDAC, the National Agency for Food and Drug Administration and Control, has registered it. This is the usual route for a finished pharmaceutical product made abroad.

  1. 01

    A Nigerian company applies

    The registration is held by a company registered in Nigeria, usually the importer or distributor. It applies to NAFDAC as the local agent of the manufacturer.

  2. 02

    The manufacturer authorises it

    The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.

  3. 03

    The dossier goes in

    The applicant submits the CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate and the product samples. We prepare all of these.

  4. 04

    NAFDAC reviews and tests

    NAFDAC assesses the dossier and has the samples analysed in its laboratories, and may ask questions, which we answer with you.

  5. 05

    The facility may be inspected

    NAFDAC may inspect the manufacturing site, or rely on the facility's GMP certification, depending on the product and the evidence provided.

  6. 06

    Registration and renewal

    On approval NAFDAC issues a registration number, which goes on every pack. The registration is valid for a fixed period and is renewed before it expires.

Registration takes from several months to more than a year, and NAFDAC updates its requirements from time to time, so check the current guidelines with NAFDAC or your regulatory agent. Many importers register a few products first and add more as orders grow.

Who does what when you import into Nigeria

A clear split of the paperwork, so nothing falls between the importer and the manufacturer.

Your company handles

  • The NAFDAC application, as the registered local company
  • The licences your business needs to import and wholesale medicines
  • The NAFDAC import permit for each consignment
  • The Form M, through your bank, and payment
  • Customs clearance at the port, through your clearing agent

Progene Pharma handles

  • The CTD dossier, stability data and samples
  • The COPP, the GMP certificate and the letter of authorisation
  • A Certificate of Analysis for every batch
  • Labels and leaflets with your NAFDAC number
  • Invoice, packing list and certificate of origin
  • Answers to NAFDAC's questions during review

Made for Nigerian conditions

Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.

  • Built for the climate

    Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition NAFDAC and most African regulators expect, with alu-alu or PVDC blisters and sealed bottles for humid conditions.

  • Labels NAFDAC accepts

    English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details NAFDAC requires.

  • Protection from counterfeits

    Counterfeit medicines are a real problem in Nigeria, so we can add holograms, tamper-evident seals and codes that fit NAFDAC's mobile authentication, to protect your brand and your patients.

  • Cartons for long roads

    Strong outer cartons and palletised loads for the road journey from Lagos to Kano, Abuja and the east, where handling is rough and loads sit in heat.

Shipping to Nigeria

Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.

  • Lagos

    Apapa, Tin Can Island and the Lekki Deep Sea Port, with Murtala Muhammed Airport for air freight

  • Port Harcourt

    The Onne ports, for the south-east, the Niger Delta and onward road freight

  • Abuja and the north

    By road from Lagos, or by air to Abuja and Kano

  • Terms and documents

    FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the NAFDAC import permit and Form M from your side

Where Nigerian distributors sell

The same registered product moves through several channels, and each needs its own pack.

Questions about supplying Nigeria

Something else? Email [email protected].

Do you export medicines to Nigeria?

Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Nigeria.

Can you help us register products with NAFDAC?

Yes. Progene Pharma prepares the documents NAFDAC registration needs: a CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Nigerian company submits the application, and we answer NAFDAC's questions with you.

Do I need a Nigerian company to register and import?

Yes. NAFDAC registers a medicine to a company registered in Nigeria, usually the importer or distributor, which then imports each consignment against a NAFDAC import permit. Check the current requirements with NAFDAC.

How long does NAFDAC registration take?

It varies by product and by how complete the dossier is, from several months to more than a year. A complete dossier with clear stability data and prompt answers to NAFDAC's questions helps. Many importers register a few products first and add more as orders grow.

Which documents does NAFDAC ask for?

The usual set is a CTD dossier, a COPP, a GMP certificate, stability data for Zone IVb, a letter of authorisation, product samples and artwork. NAFDAC updates its requirements from time to time, so confirm the current list with NAFDAC or your regulatory agent. We tell you what we can provide with your quotation.

What is a Form M?

Form M is the document an importer completes through an authorised bank to import goods into Nigeria. It is handled by your company and your bank, and the shipping documents we send, such as the invoice and packing list, support it.

What must the packs carry for Nigeria?

English text, the NAFDAC registration number, batch number, manufacture and expiry dates, storage conditions and the other details NAFDAC requires. We prepare the artwork to match your registration and you approve a proof before printing.

Are your medicines suitable for Nigeria's climate?

Yes. Products for Nigeria are tested at 30 °C and 75% relative humidity (Zone IVb) and packed in moisture-resistant blisters or bottles, so the shelf life stays valid in hot, humid conditions.

Can you supply federal and state tenders in Nigeria?

Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for, such as the COPP, GMP certificate and COA. Tell us the tender requirements and we will confirm what we can provide.

How are orders shipped to Lagos?

Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Lagos (Apapa, Tin Can or Lekki), or to Onne for Port Harcourt, or by air for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.

What is the minimum order quantity?

It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.

Request a quote

Send us your product requirements and target country. Our team will reply with a quotation and next steps.

Email
[email protected]
Phone
+91 22 49793146
WhatsApp
+91 90829 70494
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