Country · Africa
Pharmaceutical exports to Uganda, ready for NDA registration
Progene Pharma supplies Ugandan 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 National Drug Authority asks for, pack for the long journey inland, and ship through Mombasa or Dar es Salaam.
- Regulator
- National Drug Authority
- Labels
- English, with the registration number
- Stability
- Zone IVb, 30 °C / 75% RH
- Route in
- Mombasa or Dar es Salaam
The Ugandan medicines market in brief
Uganda is a landlocked country with a young, fast-growing population. It imports most of its medicines, which arrive by sea through Mombasa in Kenya or Dar es Salaam in Tanzania and then travel inland by road, so packaging, lead times and reliable clearing agents matter more here than on the coast.
Malaria is one of the country's biggest health burdens, and artemether and lumefantrine is the first-line treatment. HIV and tuberculosis are managed through large national programmes, and diabetes and high blood pressure are growing in Kampala and the other towns. School deworming and child health programmes buy in bulk.
Public health facilities are supplied mainly by the National Medical Stores, and faith-based and private not-for-profit facilities by the Joint Medical Store and similar bodies, while private importers, pharmacy chains and hospitals buy alongside them. What buyers share is a need for products the NDA has registered and a manufacturer that answers its questions.
Medicines we supply to Uganda
These are the medicines Ugandan 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 Kampala, Entebbe, Jinja and Gulu.
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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.
NDA registration, step by step
A medicine cannot be imported, sold or distributed in Uganda until the National Drug Authority (NDA) 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 Uganda, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to the NDA.
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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
NDA reviews it
The NDA assesses the dossier and may ask questions, which we answer with you. A dossier can also go through the East African Community's joint assessment, which reviews one file for several partner states.
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05
Samples and inspection
The samples are tested in a national laboratory, and the NDA may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the NDA 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 NDA updates its requirements from time to time, so check the current guidelines with NDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Uganda
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The NDA application, as the registered local agent
- The licences your business needs to import and wholesale medicines
- The NDA import permit or clearance for each consignment
- The customs declaration with the Uganda 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 NDA's questions during review
Made for Ugandan 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 East African authorities ask for, with alu-alu or PVDC blisters and sealed bottles for humid conditions.
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Labels the NDA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the NDA requires.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities the National Medical Stores, the Joint Medical Store and wholesalers buy.
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Cartons for the long road
Strong outer cartons and palletised loads for the road journey of more than a thousand kilometres from the coast, where loads sit in heat and handling is rough.
Shipping to Uganda
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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Mombasa
The usual route, by sea and then by road or rail along the northern corridor to Kampala
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Dar es Salaam
The alternative route, by sea and then by road through Tanzania
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Entebbe
By air to Entebbe 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 NDA permit, transit documents and customs declaration from your side
Where Ugandan distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The National Medical Stores supplies public hospitals and health centres, buys through tenders, and asks for the full document set.
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Faith-based and not-for-profit health
The Joint Medical Store and similar bodies supply mission and not-for-profit hospitals and clinics.
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Pharmacies and chains
Importers in Kampala supply pharmacy chains and community pharmacies with branded packs of the fast-moving generics.
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Regional redistribution
Wholesalers in Kampala supply neighbouring South Sudan, DR Congo and Rwanda, and need consistent labelling and documents.
Questions about supplying Uganda
Something else? Email [email protected].
Do you export medicines to Uganda?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Uganda.
Can you help us register products with NDA?
Yes. Progene Pharma prepares the documents NDA 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 Ugandan company submits the application, and we answer NDA's questions with you.
Do I need a local company to register and import?
Yes. The NDA registers a medicine through a company registered in Uganda, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with the NDA.
How long does NDA 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 NDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does NDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. NDA updates its requirements from time to time, so confirm the current list with NDA or your regulatory agent. We tell you what we can provide with your quotation.
How do medicines reach Uganda?
Uganda is landlocked, so shipments go by sea to Mombasa or Dar es Salaam and then by road or rail to Kampala, under a transit bond. Your clearing agent handles transit and customs, and we confirm the schedule with your quotation.
Can the dossier be assessed for several East African countries at once?
The East African Community runs a joint assessment that reviews one dossier for several partner states, which can save time if you plan to sell in Kenya, Tanzania or Rwanda as well. Tell us the countries and we will confirm how to prepare the file.
Can you supply the National Medical Stores and the Joint Medical Store?
Yes. Progene Pharma supplies tender packs and the documents public and faith-based supply tenders usually ask for. Send us the requirements and we will confirm what we can provide.
What must the packs carry for Uganda?
English text, the NDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the NDA 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 Uganda?
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 Uganda?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Mombasa in Kenya, or Dar es Salaam in Tanzania, with onward road freight to Kampala, or by air to Entebbe 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