14 MARCH 2018

Ketlaphela Pharmaceutical SOC Ltd, a South African State-owned pharmaceutical company released the Expression of Interest (EOI) on 9 March 2018. It is seeking suitable experienced pharmaceutical companies or consortium to partner with in order to supply essential medicines to South Africa and the region at large. The closing date for the interested partners is 28 March 2018 at 11:00, a briefing session will be held on 16 March 2018 at 9:00 at Necsa Visitors Centre, Gate 1. BID documents may be deposited in the bid box situated at Necsa Gate 3R104 Elias Motsoaledi Street (Church Street West Ext), Pelindaba.

Ketlaphela Pharmaceutical SOC Ltd ‘‘Ketlaphela’’ was created in response to the Cabinet’s directive for the country to have its own State owned pharmaceutical company. The State owned pharmaceutical company business case was premised on supplying South African manufactured Active Pharmaceutical Ingredients (APIs) and final formulated medical products mainly for communicable diseases such as HIV/AIDS, Tuberculosis, and Malaria and later non-communicable diseases including oncology initially to the South African public health sector and later to the continents public health sector.

South Africa is the single largest ARV market globally and the UNIDO[1] study has also shown that it’s commercially feasible to establish ARV manufacturing in the country. To further enhance viability, Ketlaphela is also looking at manufacturing Malaria and TB medicines. Currently just over 2.5% of South Africa’s imports are pharmaceutical products. As of 2016, pharmaceutical was the fastest growing imports product year-on-year. Pharmaceutical is the single second largest contributor to the trade deficit after oil.

The following criteria will be used to select the partner for Ketlaphela.

  •   Registered dossiers in South Africa and other African countries for essential medicines.
  •   Agreement to transfer the registered dossiers to Ketlaphela Pharmaceutical to SOC Ltd.
  •   The dossiers must be registered with World Health Organisation(WHO), United States Food and  Drug Administration (USFDA) for Essential Medicines
  •   Must have more than 10 years’ experience in the production of API’s and final formulated essential medicine products (For HIV/Aids, TB, and Malaria and others).
  •   Ability to supply minimum of (2) two million packs of ARVs per month based on the South African Government specifications.
  •   Agreement to transfer technology and other IP to Ketlaphela for manufacturing of API’s and formulated products in South Africa.
  •   Must have a healthy financial status.

To expedite Ketlaphela to commercialization, a fully dedicated team with business and pharmaceutical experience has been established to develop the bankable business case with recruitment of Project Director/General Manager in process.  South African Nuclear Energy Corporation (Necsa) and Pelchem have been jointly supporting the development work.

Ketlaphela remains on track to manufacture ARV’s in South Africa from 2021/2022 in support of the cabinet decision to establish ARV manufacturing in South Africa.

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For further Enquiries on EOI please contact:

Mr. Buyani Nsibande

Email: ketlaphelaRFI@pelchem.co.za

Tel: +27 (0) 12 305 6072

Mobile: +27 (0) 78 198 6932