State-owned pharmaceutical company Ketlaphela Pharmaceutical has released an expression of interest through which it is “seeking suitable experienced pharmaceutical companies or consortiums to partner with in order to supply essential medicines to South Africa and the region at large.”
The partner must have registered dossiers in South Africa and other African countries for essential medicines and must agree to transfer the registered dossiers to Ketlaphela Pharmaceutical, the company said in a statement on Wednesday.
“The dossiers must be registered with World Health Organisation and the US Food and Drug Administration. The partner must have more than ten years’ experience in the production of active pharmaceutical ingredients (APIs) and final formulated essential medicine products.”
The partner must have the ability to supply a minimum of two-million packs of antiretrovirals (ARVs) a month based on the South African government specifications and must agree to transfer technology and other intellectual property to Ketlaphela for manufacturing of APIs and formulated products in South Africa.
The partner must have a healthy financial status, the company added.
“To further enhance viability, Ketlaphela is also looking at manufacturing malaria and tuberculosis medicines. Currently just more than 2.5% of South Africa’s imports are pharmaceutical products. As of 2016, pharmaceutical products were the fastest growing import category year-on-year. Pharmaceutical products are the second-largest contributor to the trade deficit after oil.”
South Africa is the single largest ARV market globally and a United Nations Industrial Development Organisation study has also shown that it is commercially feasible to establish ARV manufacturing in the country.
Bid documents may be deposited in the bid box situated at South African Nuclear Energy Corporation (Necsa) Gate 3 R104 Elias Motsoaledi street, Pelindaba. The closing date is March 28 at 11:00. A briefing session will be held on March 16 at 9:00 at the Necsa Visitors Centre, Gate 1.
“To expedite Ketlaphela to commercialisation, a fully dedicated team with business and pharmaceutical experience has been established to develop the bankable business case.
Ketlaphela remains on track to manufacture ARVs in South Africa from 2021/2022 in support of the Cabinet decision to establish ARV manufacturing in South Africa, it added in the statement on Wednesday.