Country · Africa
Pharmaceutical exports to Tanzania, ready for TMDA registration
Progene Pharma supplies Tanzanian 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 Tanzania Medicines and Medical Devices Authority asks for, pack for East Africa's heat and humidity, and ship to Dar es Salaam.
- Regulator
- TMDA
- Labels
- English, Kiswahili on request
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Dar es Salaam
The Tanzanian medicines market in brief
Tanzania is the largest country in East Africa by area and one of the most populous. Its port at Dar es Salaam serves not only Tanzania but also landlocked Zambia, Malawi, Burundi and eastern DR Congo. Tanzania has a growing local pharmaceutical industry, but it still imports most of the medicines it uses.
Malaria is among the leading causes of illness, and artemether and lumefantrine is the standard first-line treatment. HIV and tuberculosis are managed through national programmes, and diabetes and high blood pressure are rising in Dar es Salaam, Dodoma, Arusha and Mwanza. School deworming and child health programmes buy in bulk.
Public hospitals and health centres are supplied mainly through the Medical Stores Department (MSD), the national procurement and distribution agency, while private importers, pharmacy chains and faith-based hospitals buy alongside it. Zanzibar has its own regulator, the Zanzibar Food and Drug Agency, so an importer that serves both needs to register with each.
Medicines we supply to Tanzania
These are the medicines Tanzanian 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 Dar es Salaam, Dodoma, Arusha and Mwanza.
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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.
TMDA registration, step by step
A medicine cannot be imported, sold or distributed in mainland Tanzania until the Tanzania Medicines and Medical Devices Authority (TMDA) 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 Tanzania, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to TMDA.
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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
TMDA reviews it
TMDA 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, and TMDA may inspect the manufacturing site or rely on its GMP certification and a review of the documents.
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06
Registration and renewal
On approval TMDA 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 TMDA updates its requirements from time to time, so check the current guidelines with TMDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Tanzania
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The TMDA application, as the registered local agent
- The licences your business needs to import and wholesale medicines
- The TMDA import permit for each consignment
- The customs declaration with the Tanzania Revenue Authority, through your clearing agent
- Payment, and clearance at Dar es Salaam
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 TMDA's questions during review
Made for Tanzanian 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 the humid coast.
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Labels TMDA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details TMDA requires. We can add Kiswahili leaflets where your customers need them.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities the Medical Stores Department, hospitals and wholesalers buy.
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Cartons for the long road
Strong outer cartons and palletised loads for the road and rail journeys from Dar es Salaam to Dodoma, Mwanza and on to Zambia, Malawi and DR Congo.
Shipping to Tanzania
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
Tanzania's main port, with onward road and rail freight to Dodoma, Arusha and Mwanza
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Transit to neighbours
By road to Zambia, Malawi, Burundi and eastern DR Congo, for importers who supply them from Tanzania
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Zanzibar
By sea from Dar es Salaam, with its own registration and permit
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the TMDA import permit and customs declaration from your side
Where Tanzanian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The Medical Stores Department supplies public hospitals and health centres, buys through tenders, and asks for the full document set.
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Private importers and pharmacies
Importers in Dar es Salaam supply pharmacy chains and community pharmacies with branded packs of the fast-moving generics.
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Hospitals and faith-based health
Regional hospitals, private clinics and faith-based health networks buy in hospital packs, often under annual contracts.
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Regional redistribution
Wholesalers in Dar es Salaam supply neighbouring countries through the port's transit routes, and need consistent labelling and documents.
Questions about supplying Tanzania
Something else? Email [email protected].
Do you export medicines to Tanzania?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Tanzania.
Can you help us register products with TMDA?
Yes. Progene Pharma prepares the documents TMDA 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 Tanzanian company submits the application, and we answer TMDA's questions with you.
Do I need a local company to register and import?
Yes. TMDA registers a medicine through a company registered in Tanzania, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with TMDA.
How long does TMDA 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 TMDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does TMDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. TMDA updates its requirements from time to time, so confirm the current list with TMDA or your regulatory agent. We tell you what we can provide with your quotation.
Does Zanzibar need a separate registration?
Yes. Zanzibar has its own regulator, the Zanzibar Food and Drug Agency, so a product sold there needs its own registration and permit. Tell us whether you supply the mainland, Zanzibar or both and we will confirm what to prepare.
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, Uganda or Rwanda as well. Tell us the countries and we will confirm how to prepare the file.
Can you supply the Medical Stores Department?
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 Tanzania?
English text, the TMDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details TMDA 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 Tanzania?
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 Tanzania?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Dar es Salaam, or by air to Dar es Salaam 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