Country · Africa
Pharmaceutical exports to Kenya, ready for PPB registration
Progene Pharma supplies Kenyan 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 Pharmacy and Poisons Board asks for, pack for East Africa's heat and humidity, and ship to Mombasa and Nairobi.
- Regulator
- Pharmacy and Poisons Board
- Labels
- English, with the registration number
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Mombasa
The Kenyan medicines market in brief
Kenya is the commercial hub of East Africa. Its port at Mombasa serves Uganda, Rwanda, South Sudan and eastern DR Congo, and its distributors in Nairobi supply pharmacies, hospitals and wholesalers well beyond its own borders. Kenya has a local pharmaceutical industry, but it still imports most of the medicines it uses.
Demand follows the country's health needs. Malaria is common in the lake region and on the coast, and artemether and lumefantrine is the first-line treatment. HIV and tuberculosis are managed through large national programmes. Diabetes and high blood pressure are growing quickly in Nairobi and the other towns, and school deworming and child health programmes buy in bulk.
Buyers range from private distributors and pharmacy chains to the Kenya Medical Supplies Authority, which procures for public health facilities, county governments, mission hospitals and NGOs. What they share is a need for products the Pharmacy and Poisons Board has registered, packs that survive the climate and the long road inland, and a manufacturer that answers the regulator's questions.
Medicines we supply to Kenya
These are the medicines Kenyan 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, hospitals and the 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 Nairobi, Mombasa and Kisumu.
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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.
PPB registration, step by step
A medicine cannot be imported, sold or distributed in Kenya until the Pharmacy and Poisons Board (PPB) has registered it. This is the usual route for a finished pharmaceutical product made abroad.
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01
A Kenyan company applies
The registration is held through a company in Kenya, the local technical representative of the manufacturer, usually the importer or distributor. It applies to the PPB.
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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 PPB reviews it
The PPB 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 are tested
The samples are analysed in a national laboratory, and the PPB may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and retention
On approval the PPB issues a registration and a registration number, which goes on every pack. The registration is kept in force by paying the periodic fees the PPB sets.
Registration takes from several months to more than a year, and the PPB updates its requirements from time to time, so check the current guidelines with the PPB or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Kenya
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The PPB application, as the local technical representative
- The PPB licences your business needs to import and wholesale medicines
- The PPB import permit for each consignment
- The import declaration through the KenTrade single window
- Customs clearance with the Kenya Revenue Authority, 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 the PPB's questions during review
Made for Kenyan 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 and lake region.
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Labels the PPB accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the PPB requires. We can add Kiswahili leaflets if you want them.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities the Kenya Medical Supplies Authority, county hospitals and wholesalers buy.
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Cartons for the long road
Strong outer cartons and palletised loads for the journey from Mombasa to Nairobi and on by road to Uganda, Rwanda and South Sudan.
Shipping to Kenya
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
Kenya's main seaport, with onward freight to Nairobi by rail or road
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Nairobi and Kisumu
By rail or road from Mombasa, or by air to Jomo Kenyatta Airport
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The region
Transit by road to Uganda, Rwanda, South Sudan and eastern DR Congo, for importers who supply them from Kenya
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the PPB import permit and import declaration from your side
Where Kenyan distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The Kenya Medical Supplies Authority and county governments buy for public hospitals and clinics through tenders, and ask for the full document set.
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Pharmacies and chains
Community pharmacies and growing chains in Nairobi, Mombasa and the other towns want branded packs of the fast-moving generics with clear labels.
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Hospitals and mission health
Private and mission hospitals, and faith-based supply organisations, buy in hospital packs, often under annual contracts.
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Regional redistribution
Wholesalers in Nairobi supply pharmacies and hospitals in Uganda, Rwanda and South Sudan, and need products with consistent labelling and documents.
Questions about supplying Kenya
Something else? Email [email protected].
Do you export medicines to Kenya?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Kenya.
Can you help us register products with the Pharmacy and Poisons Board?
Yes. Progene Pharma prepares the documents PPB 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 Kenyan company submits the application, and we answer the PPB's questions with you.
Do I need a local company to register and import?
Yes. The PPB registers a medicine through a company in Kenya, the local technical representative, which must also hold the right licence to import and wholesale medicines. Check the current requirements with the PPB.
How long does PPB 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 PPB's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does the PPB 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 PPB updates its requirements from time to time, so confirm the current list with the PPB or your regulatory agent. We tell you what we can provide with your quotation.
Can the dossier be assessed for several East African countries at once?
The East African Community runs a joint assessment procedure that reviews one dossier for several partner states, which can save time if you plan to sell in Uganda, Tanzania or Rwanda as well. Tell us the countries and we will confirm how to prepare the file.
What is a PPB import permit?
It is the permit your company obtains from the PPB for each consignment of medicines it imports, alongside the import declaration lodged through the KenTrade single window. Your company and your clearing agent handle it, and the shipping documents we send support it.
What must the packs carry for Kenya?
English text, the PPB registration number, batch number, manufacture and expiry dates, storage conditions and the other details the PPB requires. We prepare the artwork to match your registration and you approve a proof before printing.
Can you supply tenders from KEMSA and county governments?
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 Mombasa and Nairobi?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Mombasa, with onward freight to Nairobi, or by air to Nairobi 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