Country · Africa
Pharmaceutical exports to Malawi, ready for PMRA registration
Progene Pharma supplies Malawian 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 Medicines Regulatory Authority asks for, pack for the long road inland, and ship through Nacala, Beira or Dar es Salaam.
- Regulator
- PMRA
- Labels
- English, with the registration number
- Stability
- Zone IVb, 30 °C / 75% RH
- Route in
- Nacala, Beira, Dar es Salaam
The Malawian medicines market in brief
Malawi is a landlocked country in Southern Africa. Its medicines arrive by sea through Nacala or Beira in Mozambique, or Dar es Salaam in Tanzania, and then travel inland by road, so packaging, lead times and reliable clearing agents matter. It has a small local pharmaceutical industry and imports most of the medicines it uses.
Malaria is common throughout the year, and artemether and lumefantrine is the first-line treatment. HIV prevalence is high, so antiretrovirals are bought at scale through national programmes, and tuberculosis, antibiotics, pain medicines and, increasingly, diabetes and high blood pressure add to demand in Lilongwe, Blantyre and Mzuzu.
Public health facilities are supplied mainly through the Central Medical Stores Trust, while private importers, pharmacies, mission hospitals and NGOs buy alongside it. Donor-funded programmes are among the largest buyers and expect complete documentation.
Medicines we supply to Malawi
These are the medicines Malawian 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 Lilongwe, Blantyre and Mzuzu.
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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.
PMRA registration, step by step
A medicine cannot be imported, sold or distributed in Malawi until the Pharmacy and Medicines Regulatory Authority (PMRA) 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 Malawi, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to the PMRA.
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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
PMRA reviews it
The PMRA assesses the dossier and may ask questions, which we answer with you. Malawi also takes part in collaboration between Southern African regulators that share the assessment of a dossier.
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05
Samples and inspection
The samples are tested, and the PMRA may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the PMRA 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 PMRA updates its requirements from time to time, so check the current guidelines with PMRA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Malawi
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The PMRA application, as the registered local agent
- The licences your business needs to import and wholesale medicines
- The PMRA import permit for each consignment
- The customs declaration with the Malawi Revenue Authority, through your clearing agent
- Transit 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 PMRA's questions during review
Made for Malawian 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 the PMRA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the PMRA requires.
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Packs for every channel
Pharmacy packs, hospital packs, programme packs and tender packs in the quantities the central medical stores, mission hospitals and NGOs buy.
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Cartons for the long road
Strong outer cartons and palletised loads for road journeys of well over a thousand kilometres from the coast, where loads sit in heat and handling is rough.
Shipping to Malawi
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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Nacala and Beira
The usual routes, by sea and then by road through Mozambique to Blantyre and Lilongwe
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Dar es Salaam
The alternative route, by sea and then by road through Tanzania to northern Malawi
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Lilongwe
By air to Kamuzu 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 PMRA permit, transit documents and customs declaration from your side
Where Malawian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The Central Medical Stores Trust supplies public hospitals and clinics, buys through tenders, and asks for the full document set.
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NGOs and donor programmes
International organisations buy malaria, HIV, tuberculosis and child health products in bulk and expect complete documentation.
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Pharmacies and private importers
Importers in Lilongwe and Blantyre supply pharmacies and clinics with branded packs of the fast-moving generics.
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Mission and private hospitals
Mission hospitals and private clinics buy in hospital packs, often under annual contracts.
Questions about supplying Malawi
Something else? Email [email protected].
Do you export medicines to Malawi?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Malawi.
Can you help us register products with PMRA?
Yes. Progene Pharma prepares the documents PMRA 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 Malawian company submits the application, and we answer PMRA's questions with you.
Do I need a local company to register and import?
Yes. The PMRA registers a medicine through a company registered in Malawi, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with the PMRA.
How long does PMRA 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 PMRA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does PMRA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. PMRA updates its requirements from time to time, so confirm the current list with PMRA or your regulatory agent. We tell you what we can provide with your quotation.
How do medicines reach Malawi?
Malawi is landlocked, so shipments go by sea to Nacala, Beira or Dar es Salaam and then by road to Blantyre and Lilongwe, under a transit bond. Your clearing agent handles transit and customs, and we confirm the schedule with your quotation.
Can you supply the Central Medical Stores Trust?
Yes. Progene Pharma supplies tender packs and the product documents public 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.
Can you supply NGO and donor programmes?
Yes. We supply programme packs and the full document set that international organisations expect, including the COPP, GMP certificate and COA. Tell us the programme's requirements and we will confirm what we can provide.
What must the packs carry for Malawi?
English text, the PMRA registration number, batch number, manufacture and expiry dates, storage conditions and the other details PMRA 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 Malawi?
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 Malawi?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Nacala, Beira or Dar es Salaam, with onward road freight to Lilongwe and Blantyre, or by air to Lilongwe 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