Country · Africa
Pharmaceutical exports to Zambia, ready for ZAMRA registration
Progene Pharma supplies Zambian 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 Zambia Medicines Regulatory Authority asks for, pack for the long road inland, and ship through Dar es Salaam, Durban or Beira.
- Regulator
- ZAMRA
- Labels
- English, with the registration number
- Stability
- Zone IVb, 30 °C / 75% RH
- Route in
- Dar es Salaam, Durban, Beira
The Zambian medicines market in brief
Zambia is a landlocked country in Southern Africa. Its medicines arrive by sea through Dar es Salaam in Tanzania, Durban in South Africa or Beira in Mozambique and then travel inland by road, so packaging, lead times and reliable clearing agents matter. Zambia has a small local pharmaceutical industry and imports most of the medicines it uses.
Malaria is common, and artemether and lumefantrine is the standard first-line treatment. HIV prevalence is among the highest in the world, so antiretrovirals and the medicines for related infections are bought at very large scale through national programmes, and tuberculosis, diabetes and high blood pressure add to demand in Lusaka and the Copperbelt towns of Ndola and Kitwe.
Public health facilities are supplied mainly through Medical Stores Limited, the national medical supplies company, while private importers, pharmacy chains, mission hospitals and the mining companies' clinics buy alongside it. Zambia also takes part in the ZAZIBONA collaboration, which lets regulators in Southern Africa share the assessment of a dossier.
Medicines we supply to Zambia
These are the medicines Zambian 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 Lusaka, Ndola and Kitwe.
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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.
ZAMRA registration, step by step
A medicine cannot be imported, sold or distributed in Zambia until the Zambia Medicines Regulatory Authority (ZAMRA) 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 Zambia, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to ZAMRA.
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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
ZAMRA reviews it
ZAMRA assesses the dossier and may ask questions, which we answer with you. A dossier can also go through the ZAZIBONA collaboration, which shares the assessment between several Southern African regulators.
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05
Samples and inspection
The samples are tested, and ZAMRA may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval ZAMRA 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 ZAMRA updates its requirements from time to time, so check the current guidelines with ZAMRA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Zambia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ZAMRA application, as the registered local agent
- The licences your business needs to import and wholesale medicines
- The ZAMRA import permit for each consignment
- The customs declaration with the Zambia Revenue Authority, through your clearing agent
- Transit bonds and the road journey inland
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 ZAMRA's questions during review
Made for Zambian 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 African authorities ask for, with alu-alu or PVDC blisters and sealed bottles for humid conditions.
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Labels ZAMRA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details ZAMRA requires.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities Medical Stores Limited, mission hospitals and wholesalers buy.
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Cartons for the long road
Strong outer cartons and palletised loads for the road journey of well over a thousand kilometres from the coast, where loads sit in heat and handling is rough.
Shipping to Zambia
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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Dar es Salaam
The usual route, by sea and then by road through Tanzania to Lusaka and the Copperbelt
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Durban and Beira
The alternative routes, through South Africa or Mozambique, depending on the schedule and the destination
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Lusaka
By air to Kenneth Kaunda International Airport for urgent orders and samples
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the ZAMRA permit, transit documents and customs declaration from your side
Where Zambian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
Medical Stores Limited supplies public hospitals and clinics, buys through tenders, and asks for the full document set.
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Mission and private hospitals
Mission hospitals and private clinics buy in hospital packs, often under annual contracts.
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Pharmacies and chains
Importers in Lusaka supply pharmacy chains and community pharmacies with branded packs of the fast-moving generics.
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Mining and regional supply
Company clinics on the Copperbelt, and wholesalers who supply neighbouring countries, need consistent labelling and documents.
Questions about supplying Zambia
Something else? Email [email protected].
Do you export medicines to Zambia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Zambia.
Can you help us register products with ZAMRA?
Yes. Progene Pharma prepares the documents ZAMRA 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 Zambian company submits the application, and we answer ZAMRA's questions with you.
Do I need a local company to register and import?
Yes. ZAMRA registers a medicine through a company registered in Zambia, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with ZAMRA.
How long does ZAMRA 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 ZAMRA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does ZAMRA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. ZAMRA updates its requirements from time to time, so confirm the current list with ZAMRA or your regulatory agent. We tell you what we can provide with your quotation.
What is ZAZIBONA?
It is a collaboration between medicines regulators in Southern Africa, including Zambia, that share the assessment of a dossier so a product can be reviewed once for several countries. Tell us the countries you plan to sell in and we will confirm how to prepare the file.
How do medicines reach Zambia?
Zambia is landlocked, so shipments go by sea to Dar es Salaam, Durban or Beira and then by road to Lusaka, under a transit bond. Your clearing agent handles transit and customs, and we confirm the schedule with your quotation.
Can you supply Medical Stores Limited?
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 Zambia?
English text, the ZAMRA registration number, batch number, manufacture and expiry dates, storage conditions and the other details ZAMRA requires. 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 Zambia?
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 Zambia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Dar es Salaam, Durban or Beira, with onward road freight to Lusaka, or by air to Lusaka 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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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