TanzaniaW. SaharaDem. Rep. CongoSomaliaKenyaSudanChadSouth AfricaLesothoZimbabweBotswanaNamibiaSenegalMaliMauritaniaBeninNigerNigeriaCameroonTogoGhanaCôte d’IvoireGuineaGuinea-BissauLiberiaSierra LeoneBurkina FasoCentral African Rep.CongoGabonEq. GuineaZambiaMalawiMozambiqueeSwatiniAngolaBurundiMadagascarGambiaTunisiaAlgeriaEritreaMoroccoEgyptLibyaEthiopiaDjiboutiSomalilandUgandaRwandaS. Sudan

African markets supplied by Vibcare Healthcare, shown in blue.

Pharmaceutical Exports to Africa from India

14 markets across West, East, Southern and Central Africa

Africa is the largest export region for Vibcare Healthcare: 14 of the 22 markets supplied are here. Products are registered through the importer with the national regulator, and in the East African Community and the SADC ZAZIBONA procedure a single assessment can be shared across several countries. Stability studies run in our own chambers at the conditions the market’s climatic zone requires.

Sub-regions and regulatory blocs

How registration is approached in each part of the region

West Africa, anglophone
Registration with NAFDAC in Nigeria and the Ghana FDA. Both regulators work within the ECOWAS harmonisation programme led by WAHO, with dossiers in CTD format and English labelling.

West Africa, francophone (UEMOA)
National registration with French-language dossiers and labelling, within the UEMOA and ECOWAS harmonisation frameworks.

East Africa
Kenya, Tanzania and Uganda take part in the East African Community medicines regulatory harmonisation programme, with a joint assessment procedure alongside national registration at the Pharmacy and Poisons Board, TMDA and NDA. Ethiopia registers nationally through EFDA.

Southern Africa (SADC)
MCAZ in Zimbabwe and ZAMRA in Zambia are active members of ZAZIBONA, the SADC collaborative registration procedure, so one joint assessment can support registration in both.

Central Africa (CEMAC)
National registration in Cameroon with French-language dossiers and labelling.

What we supply to the region

From the 39 export approvals and the four sections of the plant

Tablets

34 export approvals: cardiovascular, anti-infective, gastro-intestinal, CNS and pain, anti-allergic and metabolic products to USP and BP monographs.

Capsules

Omeprazole gastro-resistant, duloxetine delayed-release, pregabalin and tamsulosin modified-release capsules.

Oral liquids

Azithromycin oral suspension USP; further syrups and suspensions registered against a confirmed importer.

Documentation

Site and product documents, stability data for the climatic zone, and packing in the regulator’s language. Details on the exports page.

Questions importers ask

Before you send a requirement list

Which African countries do you supply?

Nigeria, Ghana, Côte d’Ivoire, Benin, Mali and Burkina Faso in West Africa; Kenya, Tanzania, Uganda and Ethiopia in East Africa; Zimbabwe and Zambia in Southern Africa; and Cameroon in Central Africa.

Do you provide French-language dossiers and packs?

Yes. Packs, leaflets and the documentation the regulator asks for are prepared in French for the francophone markets, working with your registration agent.

Is your stability data suitable for African markets?

Yes. Studies run in our own chambers at the conditions of the market’s climatic zone, including the hot and humid zone IVb conditions most of the continent falls under.

Can one registration cover several countries?

Partly. The EAC joint assessment and the SADC ZAZIBONA procedure share one assessment across member countries, but each national regulator still issues its own registration.

Which documents do you supply for NAFDAC or Ghana FDA registration?

Site documents, product specifications and methods, batch records, certificates of analysis and stability data, plus the items on the regulator’s checklist, agreed at the proposal stage.

Talk to us about supply to Africa

Send the country, the products and the regulator’s requirement list. You will get feasibility, rate, lead time and the documentation scope in writing.

info.vh@vibcare.co.in  ·  +91 85660 76607  ·  Khasra 6/2/2, Kot Road, Village Dabkori, Panchkula, Haryana 134103