SA’s leading generic drug manufacturer, Aspen Pharmacare, warned that local production of the breakthrough HIV prevention injection lenacapavir will only be viable if manufacturers are guaranteed demand. – Business Day (16 Marh 2026)
The country was excluded from the initial 2024 voluntary licences issued by Gilead Sciences to six generic producers because none of the local firms could meet the requirement to manufacture the active pharmaceutical ingredient (API) in-house.
Lenacapavir, a twice-yearly injectable following an oral dose, has shown near-complete protection against HIV infection.
The SA National Aids Council is now negotiating revised terms that may allow local firms to import the API initially. Aspen argues that guaranteed off-take and preferential procurement are essential to justify investment. Limited sterile manufacturing capacity and competition from cheaper imports further complicate prospects for sustainable local production.