Country · Africa
Pharmaceutical exports to Ghana, ready for FDA registration
Progene Pharma supplies Ghanaian 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 the Food and Drugs Authority asks for, pack for Ghana's heat and humidity, and ship to Tema and Takoradi.
- Regulator
- Food and Drugs Authority
- Labels
- English, with the registration number
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Tema, Takoradi
The Ghanaian medicines market in brief
Ghana is one of the best-organised pharmaceutical markets in West Africa. English is the language of business and regulation, the Food and Drugs Authority (FDA) is an established regulator, and the port of Tema is a main gateway for the whole region. Ghana has local manufacturers, but it still imports most of the medicines it uses.
Demand follows the country's health needs. Malaria is among the most common reasons for a visit to a clinic, and artemisinin-based combinations such as artemether and lumefantrine and artesunate and amodiaquine are the standard treatment. HIV and tuberculosis are managed through national programmes, diabetes and high blood pressure are growing in Accra and Kumasi, and the National Health Insurance Scheme brings many everyday medicines within reach of more patients.
Buyers range from private importers and wholesale distributors to pharmacy chains, hospitals, faith-based health networks and the public supply system. Some Ghanaian wholesalers also supply neighbouring countries. What they share is a need for products the FDA has registered, packs that survive the climate, and a manufacturer that answers the regulator's questions.
Medicines we supply to Ghana
These are the medicines Ghanaian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Antimalarials
Artemether and lumefantrine tablets, dispersible tablets and dry syrup, and artesunate injection, for pharmacies, clinics and the national malaria programme.
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Antibiotics
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, in adult and paediatric forms.
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Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections, the fastest-moving products in community pharmacies.
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HIV and tuberculosis
Antiretrovirals such as lamivudine and zidovudine, and rifampicin, isoniazid, ethambutol and pyrazinamide, for national programmes and treatment centres.
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Diabetes and blood pressure
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become more common in Accra, Kumasi and Takoradi.
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Deworming and child health
Albendazole for school deworming, and oral rehydration salts with zinc for children with diarrhoea.
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Mother and child health
Iron with folic acid for pregnancy, vitamin B complex, vitamin D3 and paediatric syrups.
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Hospital supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital and tender packs.
FDA registration, step by step
A medicine cannot be imported, sold or distributed in Ghana until the Food and Drugs Authority (FDA) has registered it. This is the usual route for a finished pharmaceutical product made abroad.
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01
A Ghanaian company applies
The registration is held by a company registered in Ghana, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to the FDA.
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02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
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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 samples. We prepare all of these.
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04
The FDA reviews it
The FDA assesses the dossier and may ask questions, which we answer with you. A dossier can also go through the ECOWAS joint assessment, which reviews one file for several West African states.
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05
Samples are tested
The samples are analysed in the FDA's laboratories, and the FDA may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the FDA issues a registration and 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 the FDA updates its requirements from time to time, so check the current guidelines with the FDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Ghana
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The FDA application, as the registered local company
- The licences your business needs to import and wholesale medicines
- The FDA import permit for each consignment
- The customs declaration, through your clearing agent
- Payment, and clearance with the Ghana Revenue Authority
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 registration number
- Invoice, packing list and certificate of origin
- Answers to the FDA's questions during review
Made for Ghanaian conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
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Built for the climate
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition West African authorities ask for, with alu-alu or PVDC blisters and sealed bottles for the humid coast.
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Labels the FDA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the FDA requires.
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Protection from counterfeits
Counterfeit medicines are a concern across West Africa, so we can add holograms, tamper-evident seals and codes that work with mobile authentication, to protect your brand and your patients.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities wholesalers, hospitals and the public supply system buy.
Shipping to Ghana
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
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Tema
Ghana's main container port, a short road journey from Accra, and a transit route for neighbouring countries
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Takoradi
The second port, for the west of the country and onward road freight
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Accra and Kumasi
By road from Tema, or by air to Kotoka International Airport for urgent orders
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the FDA import permit and customs declaration from your side
Where Ghanaian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Wholesalers and distributors
Importers in Accra, Kumasi and Tema supply pharmacies and hospitals across the country, and some supply neighbouring markets.
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Pharmacies and chains
Community pharmacies and growing chains want branded packs of the fast-moving generics, with clear labels and consistent quality.
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Hospitals and faith-based health
Teaching hospitals, regional hospitals, private clinics and faith-based health networks buy in hospital packs, often under annual contracts.
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Public supply and programmes
Government stores, national disease programmes and NGOs buy through tenders and programme procurement, and ask for the full document set.
Questions about supplying Ghana
Something else? Email [email protected].
Do you export medicines to Ghana?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Ghana.
Can you help us register products with the Ghana FDA?
Yes. Progene Pharma prepares the documents FDA 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 Ghanaian company submits the application, and we answer the FDA's questions with you.
Do I need a Ghanaian company to register and import?
Yes. The FDA registers a medicine to a company registered in Ghana, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with the FDA.
How long does FDA 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 the FDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does the Ghana FDA 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. The FDA updates its requirements from time to time, so confirm the current list with the FDA or your regulatory agent. We tell you what we can provide with your quotation.
Can the dossier be assessed for several West African countries at once?
The ECOWAS medicines regulatory harmonisation programme runs a joint assessment that reviews one dossier for several member states, which can save time if you plan to sell in more than one West African country. Tell us the countries and we will confirm how to prepare the file.
Do you need an FDA import permit for each shipment?
Importers usually need an FDA permit for each consignment of medicines, alongside the customs declaration. Your company and your clearing agent handle it, and the shipping documents we send support it. Check the current process with the FDA.
What must the packs carry for Ghana?
English text, the FDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the FDA requires. We prepare the artwork to match your registration and you approve a proof before printing.
Can you supply government and hospital tenders in Ghana?
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 Tema?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Tema or Takoradi, or by air to Accra 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.
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- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494