Pharmaceutical exporter to Mozambique

ANARME's working language is Portuguese, and submissions are required in Portuguese across the full CTD. English documentation is accepted only when accompanied by certified Portuguese translation, which adds time and cost to first-time filings if treated as an afterthought. Our standing practice is to prepare Module 1 administrative documents and labelling in Portuguese from the first draft, with Module 2 summaries and Module 3 quality data also localised. ANARME recognises WHO-GMP for manufacturing standards and aligns with ICH guidance on bioequivalence and stability, so substantive content from dossiers prepared for other African markets is largely reusable with translation and formatting adjustment.

CMAM, the Central de Medicamentos e Artigos Médicos, is the central public-sector pharmaceutical procurement and distribution body. Tenders cover the national essential medicines list with documentation requirements including ANARME registration extract, WHO-format CPP, manufacturer GMP certificate and price justification. Provincial DPS offices manage onward allocation. Payment cycles run long — ninety to one hundred and eighty days is the operational reality — and we structure inventory holding, credit terms and master supply agreements around that timing. Mumbai-side stock holding lets us ship within CMAM contractual windows even when payment arrives later.

Yes. PEPFAR-funded ARV procurement and Global Fund TB and anti-malarial procurement are core flows on our Mozambique operation. Our manufacturing partners hold WHO prequalification on priority molecules including dolutegravir-based ARV FDCs, paediatric ARV dispersibles, four-drug TB FDCs and artemisinin-based combination anti-malarials. We coordinate donor-agency pre-shipment inspection, consignment documentation, batch certificate-of-analysis flow and USAID GHSC-PSM-aligned logistics protocols. Indian generic supply dominates these procurement streams globally and Mozambique reflects that pattern, with supply backbones running through CMAM and direct donor-managed channels.

Cabo Delgado province in northern Mozambique has security-affected zones from ongoing insurgency, particularly in coastal and inland districts. We treat these zones as operational exclusions on direct supply rather than regulatory exclusions — ANARME registration covers the full national territory. Donor-funded stocks destined for affected districts are routed through Pemba (APL) or Nampula and onward distribution into security-sensitive areas is handled by UNICEF, MSF, ICRC or programme-specific logistics partners with appropriate security infrastructure. This protects supply-chain integrity and limits our counterparty exposure to the documented portion of the corridor.

USD invoicing is the standard for B2B pharmaceutical trade given Metical volatility, with MZN clearing handled at the importer's bank. For private importer counterparties, letter of credit confirmed through a Mumbai or Dubai correspondent bank is the default first-time arrangement. CMAM contracts run on government payment cycles of ninety to one hundred and eighty days, and we structure credit terms around that reality rather than expecting faster settlement. Donor-funded flows run on programme-level master supply agreements with milestone settlement against pre-shipment inspection sign-off, which gives both sides predictable cash-flow timing.

Our Mozambique portfolio is anchored on ARVs, TB FDCs, anti-malarials, paediatric formulations, anti-infectives and cold-chain biologicals. Donor-funded volumes drive the ARV, TB and anti-malarial categories almost exclusively, with PEPFAR carrying ARV procurement, Global Fund covering TB and malaria, and UNICEF and Gavi handling paediatric and immunisation supply. Anti-infectives and paediatric formulations cover both donor-funded and CMAM essential medicines demand. Cardiovascular, diabetes and respiratory ranges supply the private-channel and tertiary-hospital demand in Maputo and Beira at smaller volume but with growing importance.

Air freight into Maputo (MPM) runs on consolidations via Doha, Addis Ababa, Nairobi and Johannesburg, with total Mumbai-Maputo transit of 28 to 48 hours. Beira (BEW) and Pemba (APL) are secondary air gateways for central and northern regions. Sea cargo into Maputo, Beira and Nacala ports runs from Mumbai via Durban or Mombasa transhipment with five-to-seven-week transit. Cold-chain product moves on CEIV Pharma-validated packaging with continuous data-logger monitoring. Cyclone-season buffer stock in Maputo and Beira absorbs disruption from major weather events between November and April.