Country · Africa
Pharmaceutical exports to Mozambique, ready for ANARME registration
Progene Pharma supplies Mozambican 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 medicines regulator, ANARME, asks for, label in Portuguese, and ship to Maputo, Beira and Nacala.
- Regulator
- ANARME
- Labels
- Portuguese required
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Maputo, Beira, Nacala
The Mozambican medicines market in brief
Mozambique is a long Indian Ocean country with three deep-water ports that also serve its landlocked neighbours Malawi, Zimbabwe and Zambia. It imports most of the medicines it uses, and Portuguese is the language of regulation and labelling, which sets it apart from most of Southern and East Africa.
Malaria is one of the leading causes of illness, 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 Maputo, Beira and Nampula.
Public health facilities are supplied mainly through the national medicines and medical supplies centre, CMAM, while private importers, pharmacies, mission and private hospitals buy alongside it. NGOs and donor programmes are also large buyers and expect complete documentation.
Medicines we supply to Mozambique
These are the medicines Mozambican 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 Maputo, Beira and Nampula.
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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.
ANARME registration, step by step
A medicine cannot be imported, sold or distributed in Mozambique until the national medicines regulator, ANARME, 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 established in Mozambique, usually the importer or distributor, acting as the local representative of the manufacturer. It applies to ANARME.
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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, with the documents in or translated into Portuguese where required. We prepare all of these.
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04
ANARME reviews it
ANARME assesses the dossier and may ask questions, which we answer with you.
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05
Samples and inspection
The samples are tested, and ANARME may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval ANARME 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 ANARME updates its requirements from time to time, so check the current guidelines with ANARME or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Mozambique
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ANARME application, as the registered local representative
- The licences your business needs to import and wholesale medicines
- The import permit for each consignment
- The customs declaration with the Mozambican tax authority, through your clearing agent
- Payment, and clearance at the port
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 ANARME's questions during review
Made for Mozambican 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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Labels in Portuguese
Cartons and patient leaflets in Portuguese, with the registration number, batch number, manufacture and expiry dates, storage conditions and the other details ANARME requires, and an approved proof before printing.
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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 the humid coast.
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Packs for every channel
Pharmacy packs, hospital packs, programme packs and tender packs in the quantities CMAM, hospitals and NGOs buy.
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Cartons for the long road
Strong outer cartons and palletised loads for the long road journeys between the ports and the interior.
Shipping to Mozambique
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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Maputo
The main port in the south, with road freight to the capital and into South Africa
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Beira
The central port, which also serves Zimbabwe and Zambia
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Nacala
The northern port, which also serves Malawi
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import permit and customs declaration from your side
Where Mozambican distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
CMAM supplies public hospitals and health centres, 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 Maputo and Beira supply pharmacies and clinics with branded packs of the fast-moving generics.
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Hospitals
Central, provincial, mission and private hospitals buy in hospital packs, often through tenders.
Questions about supplying Mozambique
Something else? Email [email protected].
Do you export medicines to Mozambique?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Mozambique.
Can you help us register products with ANARME?
Yes. Progene Pharma prepares the documents ANARME 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 Mozambican company submits the application, and we answer ANARME's questions with you.
Do I need a local company to register and import?
Yes. ANARME registers a medicine through a company established in Mozambique, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with ANARME.
How long does ANARME 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 ANARME's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does ANARME ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. ANARME updates its requirements from time to time, so confirm the current list with ANARME or your regulatory agent. We tell you what we can provide with your quotation.
Must the packs be in Portuguese?
Yes. Mozambique's regulation and labelling are in Portuguese, so cartons and leaflets carry Portuguese text. We prepare the artwork to match your registration, and you approve a proof before printing.
Can you supply the national medicines centre, CMAM?
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.
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 Mozambique?
Portuguese text, the ANARME registration number, batch number, manufacture and expiry dates, storage conditions and the other details ANARME 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 Mozambique?
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 Mozambique?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Maputo, Beira or Nacala, or by air to Maputo 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