Progene Pharma

Country · Africa

Pharmaceutical exports to DR Congo, ready for ACOREP registration

Progene Pharma supplies Congolese importers, wholesalers, NGOs and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples the Autorité Congolaise de Réglementation Pharmaceutique asks for, label in French, and ship through Matadi and the East African ports.

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Regulator
ACOREP
Labels
French required
Stability
Zone IVb, 30 °C / 75% RH
Routes in
Matadi, Dar es Salaam, Mombasa

The Congolese medicines market in brief

The Democratic Republic of the Congo is one of the largest countries in Africa by area and population, and one of the hardest to supply, because the distances are huge and roads are limited. Medicines reach the west through the port of Matadi and the east through Dar es Salaam or Mombasa and the neighbouring countries, so packaging and a capable logistics partner matter.

Malaria is the leading cause of illness and death, and HIV, tuberculosis, respiratory infections and diarrhoea add to demand for antimalarials, antibiotics, oral rehydration salts and zinc. International organisations and donor programmes are among the largest buyers and expect complete documentation.

Public health supply runs largely through regional distribution centres and the federation of essential medicine purchasing centres, alongside NGOs, faith-based health networks and private importers. Importers in Kinshasa, Lubumbashi and Goma supply their regions, and French is the language of regulation and labelling.

Medicines we supply to DR Congo

These are the medicines Congolese distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations

  • Antimalarials

    Artemether and lumefantrine tablets, dispersible tablets and dry syrup, and artesunate injection, for pharmacies, clinics and malaria programmes.

  • Antibiotics

    Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, in adult and paediatric forms.

  • Pain and fever

    Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections, the fastest-moving products in community pharmacies.

  • HIV and tuberculosis

    Antiretrovirals such as lamivudine and zidovudine, and rifampicin, isoniazid, ethambutol and pyrazinamide, for national programmes and treatment centres.

  • Diabetes and blood pressure

    Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become more common in Kinshasa, Lubumbashi and Goma.

  • Deworming and child health

    Albendazole for school deworming, and oral rehydration salts with zinc for children with diarrhoea.

  • Mother and child health

    Iron with folic acid for pregnancy, vitamin B complex, vitamin D3 and paediatric syrups.

  • Hospital supplies

    IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital and tender packs.

ACOREP registration, step by step

A medicine cannot be imported, sold or distributed in the DR Congo until the Autorité Congolaise de Réglementation Pharmaceutique (ACOREP) has granted a marketing authorisation. This is the usual route for a finished pharmaceutical product made abroad.

  1. 01

    A local company applies

    The authorisation is held by a pharmaceutical establishment in the DR Congo, usually the importer or wholesaler, acting for the manufacturer. It applies to ACOREP.

  2. 02

    The manufacturer authorises it

    The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.

  3. 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 French where required. We prepare all of these.

  4. 04

    ACOREP reviews it

    ACOREP assesses the dossier and may ask questions, which we answer with you.

  5. 05

    Samples and inspection

    The samples are tested, and ACOREP may inspect the manufacturing site or rely on its GMP certification.

  6. 06

    Registration and renewal

    On approval ACOREP issues a marketing authorisation with a number, which goes on every pack. The authorisation is valid for a fixed period and is renewed before it expires.

Registration takes from several months to more than a year, and ACOREP updates its requirements from time to time, so check the current guidelines with ACOREP or your regulatory agent. Many importers register a few products first and add more as orders grow.

Who does what when you import into DR Congo

A clear split of the paperwork, so nothing falls between the importer and the manufacturer.

Your company handles

  • The ACOREP application, through a licensed Congolese pharmaceutical establishment
  • The licences your business needs to import and distribute medicines
  • The import authorisation for each consignment
  • The customs declaration, through your transit agent
  • Transit, security and the long road or river 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 authorisation number
  • Invoice, packing list and certificate of origin
  • Answers to ACOREP's questions during review

Made for Congolese conditions

Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.

  • Labels in French

    Cartons and patient leaflets in French, with the authorisation number, batch number, manufacture and expiry dates, storage conditions and the other details ACOREP requires, and an approved proof before printing.

  • Built for the climate

    Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition Central African authorities ask for, with alu-alu or PVDC blisters and sealed bottles for hot, humid conditions.

  • Cartons for very long journeys

    Strong outer cartons and palletised loads for journeys of thousands of kilometres by road, rail and river, where loads sit in heat and handling is rough.

  • Packs for every buyer

    Pharmacy packs, hospital packs, programme packs and tender packs in the quantities distributors, NGOs and purchasing centres buy.

Shipping to DR Congo

Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.

  • Matadi

    The main seaport for the west and Kinshasa, with road and rail freight inland

  • Dar es Salaam and Mombasa

    The routes for the east, by sea and then by road through Tanzania, Uganda or Kenya to Goma, Bukavu and Lubumbashi

  • Kinshasa and Lubumbashi

    By air to N'djili and Lubumbashi airports for urgent orders and samples

  • Terms and documents

    FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import authorisation, transit documents and customs declaration from your side

Where Congolese distributors sell

The same registered product moves through several channels, and each needs its own pack.

Questions about supplying DR Congo

Something else? Email [email protected].

Do you export medicines to DR Congo?

Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in DR Congo.

Can you help us register products with ACOREP?

Yes. Progene Pharma prepares the documents ACOREP 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 Congolese company submits the application, and we answer ACOREP's questions with you.

Do I need a local company to register and import?

Yes. ACOREP grants an authorisation to a pharmaceutical establishment in the DR Congo, usually the importer or wholesaler, which must also hold the licences to import and distribute medicines. Check the current requirements with ACOREP.

How long does ACOREP 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 ACOREP's questions helps. Many importers register a few products first and add more as orders grow.

Which documents does ACOREP ask for?

The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. ACOREP updates its requirements from time to time, so confirm the current list with ACOREP or your regulatory agent. We tell you what we can provide with your quotation.

How do medicines reach the east and the west of the DR Congo?

The west is supplied through the port of Matadi and the road and rail links to Kinshasa. The east is usually supplied by sea to Dar es Salaam or Mombasa and then by road through the neighbouring countries. Your transit agent handles the journey, and we confirm the schedule with your quotation.

Must the packs be in French?

Yes. The DR Congo's regulation and labelling are in French, so cartons and leaflets carry French text. We prepare the artwork to match your registration, and you approve a proof before printing.

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 DR Congo?

French text, the ACOREP authorisation number, batch number, manufacture and expiry dates, storage conditions and the other details ACOREP 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 DR Congo?

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 DR Congo?

Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Matadi for the west, or to Dar es Salaam or Mombasa for the east, or by air to Kinshasa 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.

Request a quote

Send us your product requirements and target country. Our team will reply with a quotation and next steps.

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Email
[email protected]
Phone
+91 22 49793146
WhatsApp
+91 90829 70494
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