Country · Africa
Pharmaceutical exports to Ethiopia, ready for EFDA registration
Progene Pharma supplies Ethiopian 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 Ethiopian Food and Drug Authority asks for, pack for the long road from the port, and ship through Djibouti.
- Regulator
- Ethiopian Food and Drug Authority
- Labels
- English, Amharic where required
- Stability
- Zone IVb, 30 °C / 75% RH
- Route in
- Djibouti
The Ethiopian medicines market in brief
Ethiopia is the second most populous country in Africa and a landlocked one. Its medicines arrive by sea through the port of Djibouti and then travel inland by road and rail, so packaging and a reliable clearing agent matter. Ethiopia has a growing local pharmaceutical industry, but it still imports a large share of the medicines it uses.
Malaria, HIV and tuberculosis are managed through national programmes, antibiotics and pain medicines are in steady demand, and diabetes and high blood pressure are rising in Addis Ababa and the other cities. Maternal and child health programmes buy iron, folic acid, zinc and oral rehydration salts in bulk.
Public hospitals and health centres are supplied mainly through the Ethiopian Pharmaceutical Supply Service (EPSS), the national procurement and distribution agency, while private importers, wholesalers and pharmacies buy alongside it. Foreign currency and payment terms need early planning, so we agree them clearly before an order.
Medicines we supply to Ethiopia
These are the medicines Ethiopian 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 malaria programmes.
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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 Addis Ababa, Dire Dawa and Hawassa.
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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.
EFDA registration, step by step
A medicine cannot be imported, sold or distributed in Ethiopia until the Ethiopian Food and Drug Authority (EFDA) has registered it. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
The registration is held by a company registered in Ethiopia, usually the importer or wholesaler, acting as the local agent of the manufacturer. It applies to the EFDA.
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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 stability data for the required climate zone, the WHO-format COPP, the GMP certificate and the samples. We prepare all of these.
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04
EFDA reviews it
The EFDA assesses the dossier and may ask questions, which we answer with you.
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05
Samples and inspection
The samples are tested in the EFDA's laboratory, and the EFDA may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the EFDA 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 EFDA updates its requirements from time to time, so check the current guidelines with EFDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Ethiopia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The EFDA application, as the registered local agent
- The licences your business needs to import and wholesale medicines
- The EFDA import permit for each consignment
- Foreign currency, bank permits and payment
- Customs clearance, 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 registration number
- Invoice, packing list and certificate of origin
- Answers to EFDA's questions during review
Made for Ethiopian 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 most African authorities ask for, with alu-alu or PVDC blisters and sealed bottles for hot and humid conditions.
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Labels the EFDA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the EFDA requires. We can add Amharic text where your registration asks for it.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities the Ethiopian Pharmaceutical Supply Service, hospitals and wholesalers buy.
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Cartons for the long road
Strong outer cartons and palletised loads for the road and rail journey from Djibouti to Addis Ababa, a trip of several days.
Shipping to Ethiopia
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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Djibouti
The main port for Ethiopia, with onward road or rail freight to Addis Ababa
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Addis Ababa
By air to Bole International Airport for urgent orders and samples
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Within Ethiopia
Onward road freight to Dire Dawa, Hawassa, Bahir Dar and the regions
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the EFDA permit, bank documents and customs declaration from your side
Where Ethiopian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The Ethiopian Pharmaceutical Supply Service supplies public hospitals and health centres, buys through tenders, and asks for the full document set.
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Wholesalers and importers
Private importers in Addis Ababa supply pharmacies, clinics and hospitals across the country.
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Pharmacies and drug shops
Community pharmacies and drug shops want branded packs of the fast-moving generics, with clear labels and consistent quality.
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Hospitals and programmes
Teaching hospitals, private hospitals and NGOs buy in hospital and programme packs, often through tenders.
Questions about supplying Ethiopia
Something else? Email [email protected].
Do you export medicines to Ethiopia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Ethiopia.
Can you help us register products with EFDA?
Yes. Progene Pharma prepares the documents EFDA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Ethiopian company submits the application, and we answer EFDA's questions with you.
Do I need a local company to register and import?
Yes. The EFDA registers a medicine through a company registered in Ethiopia, usually the importer or wholesaler, which must also hold the licences to import and wholesale medicines. Check the current requirements with the EFDA.
How long does EFDA 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 EFDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does EFDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. EFDA updates its requirements from time to time, so confirm the current list with EFDA or your regulatory agent. We tell you what we can provide with your quotation.
How do medicines reach Ethiopia?
Ethiopia is landlocked, so shipments go by sea to Djibouti and then by road or rail to Addis Ababa. Your clearing agent handles the port and customs, and we confirm the schedule with your quotation.
How is payment handled?
Foreign currency availability and the bank's requirements can affect payment, so we agree the payment terms with you before an order and tell you which documents your bank needs. A letter of credit is common.
Can you supply the Ethiopian Pharmaceutical Supply Service?
Yes. Progene Pharma supplies tender packs and the documents public tenders usually ask for. Send us the tender requirements and we will confirm what we can provide.
What must the packs carry for Ethiopia?
English text, the EFDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the EFDA requires, and Amharic where your registration asks for it. We prepare the artwork to match your registration and you approve a proof before printing.
Are your medicines suitable for the climate?
Yes. Products for this market 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 tenders in Ethiopia?
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 Ethiopia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Djibouti, with onward road or rail freight to Addis Ababa, or by air to Addis Ababa 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.
Related pages
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494