Country
πŸ‡°πŸ‡ͺ Kenya
Regulator
Pharmacy and Poisons Board (PPB)
Capital
Nairobi
Region
Africa
Currency
Kenyan Shilling
Official Lang.
English, Swahili
Dial Code
+254
ISO Code
KE

Supply & Market

Kenya serves as a regional East African hub with active public-sector procurement and private distribution channels. PPB (Pharmacy and Poisons Board) regulates pharmaceutical products with WHO-PQ aligned dossier standards. Taj Pharma supplies DEFRATAJ Deferasirox dispersible tablets for pediatric and adult iron-overload programmes through qualified Kenyan partners.

Supply to Kenya is via CIF Mombasa port and Nairobi airfreight - transit typically 10-14 days by sea, 3-5 days by air. Kenya is a practical regional hub for East African redistribution (Tanzania, Uganda, Rwanda). Safety-stock allocation for Kenyan distributors supports both KEMSA (public-sector) participation and private-pharmacy distribution.

PPB registration is a WHO-PQ aligned full-dossier pathway. Required documentation includes Module 1-5 CTD with Kenya-specific Module 1, CoPP on WHO format, GMP certificate, bioequivalence summary, stability data (ICH Q1A Zone IVb recommended) and proposed SmPC / patient information leaflet. Fast-track / expedited review may apply for public-health priority products. Typical registration timeline 9-18 months. Post-approval variations and renewals are supported by our RA team.

Other Markets in Africa