Pharmaceutical exporter to DR Congo

ACOREP requires submissions in French across the full CTD, including Module 1 administrative documents, Module 2 summaries, Module 3 quality data, labelling artwork and patient information leaflets. English-only filings are rejected at administrative review without proceeding to scientific assessment. Our standing practice is to prepare the dossier in French from the first draft with native-speaker regulatory writers and review by a Kinshasa-based ACOREP liaison. This reflects the 2021 reform that established ACOREP as a more autonomous and discipline-driven regulator than its DPM predecessor, and matches the working language of agency reviewers.

FEDECAME coordinates central public-sector pharmaceutical procurement with provincial CDR entities handling onward distribution. Tenders cover essential medicines list categories with WHO prequalification preference for several therapeutic groups, particularly ARVs, TB regimens and anti-malarials. Documentation requirements include ACOREP registration extract, WHO-format CPP, manufacturer GMP certificate and donor-aligned pharmacovigilance commitments. We coordinate the full bid through our Kinshasa partner, hold Mumbai-side inventory against allocation calls and align with donor-agency procurement cycles where Global Fund, Gavi or USAID GHSC-PSM are co-financing the tender.

Yes — donor-funded procurement is core to our DR Congo operation. We supply WHO-prequalified ARVs, fixed-dose TB regimens, ACT anti-malarials and paediatric formulations to Global Fund, Gavi, UNICEF Supply Division, USAID GHSC-PSM and MSF channels. Our manufacturing partners hold WHO prequalification on the priority molecules, and our regulatory desk maintains donor-agency-aligned pharmacovigilance and pre-shipment inspection documentation. We coordinate consignment dossiers, certificates of analysis batch by batch and donor-agency QA inspection access at the manufacturing site without intermediation.

We treat North Kivu, South Kivu and Ituri as operational exclusions rather than regulatory exclusions. ACOREP registration covers the full national territory, but our direct supply lanes terminate at Kinshasa, Matadi and Lubumbashi (FBM) for Katanga. Donor-funded stocks destined for eastern operations are delivered to Kinshasa or Lubumbashi and onward distribution into security-sensitive zones is handled by UNICEF, MSF, ICRC or Global Fund-managed logistics partners with the appropriate security infrastructure. This protects supply-chain integrity and limits our counterparty exposure to the documented portion of the corridor.

Congolese Franc convertibility is limited and the currency carries meaningful volatility, so B2B pharmaceutical trade defaults to USD invoicing. We settle through correspondent relationships with Equity BCDC, Trust Merchant Bank and FBN Bank, with letter of credit confirmed through a Mumbai or Dubai correspondent for first-time private-importer counterparties. Donor-funded flows typically run on advance payment or programme-level master supply agreements with milestone settlement against pre-shipment inspection sign-off. Consignment-stock arrangements are available for high-volume essential medicines where ACOREP-licenced warehousing is in place.

Our DRC portfolio centres on HIV antiretrovirals, TB fixed-dose combinations, anti-malarials, paediatric formulations, anti-infectives and outbreak-response stocks. Donor-funded volumes drive the ARV, TB and anti-malarial categories almost exclusively, with Indian generic manufacturers dominating WHO-prequalified supply. Anti-infectives and paediatric formulations cover both donor-funded and FEDECAME public-sector demand. Outbreak preparedness for Ebola and mpox draws on cold-chain capacity coordinated with WHO and UNICEF when activated. Cardiovascular and diabetes ranges supply the private and tertiary-hospital channel in Kinshasa and Lubumbashi at smaller volume.

Air freight into N'djili International (FIH) runs on consolidations via Addis Ababa, Nairobi, Doha and Dubai, with total Mumbai-Kinshasa transit of 36 to 60 hours depending on routing. Sea cargo into Matadi runs from Bandar Abbas or Durban transhipment with seven-to-ten-week transit, used for ambient bulk where shelf life supports the cycle. Lubumbashi (FBM) handles Katanga directly. Cold-chain product moves on CEIV Pharma-validated packaging with continuous data-logger monitoring, and onward distribution to provincial CDR warehouses runs on bonded road transport with documented chain-of-custody.