INDUSTRY FOCUS: MANUFACTURING
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In June 2018, Dr Hannes Malan – Managing Director of South Africa’s Chemical Process Technologies (CPT) – told Enterprise Africa that the company was formulating a plan to expand into the manufacture of medicines for human use. Founded in 2001, already an expert in the manufacture and production of active pharmaceutical ingredients (APIs) for use in the animal health and research industries among others, the company established CPT Pharma with support from the Industrial Development
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Corporation (IDC) and the Technology Innovation Agency (TIA), an entity of the Department of Science and Innovation. The goal for CPT Pharma has always been to react to the opportunity of import replacement of APIs. APIs are the component in a medicine which provide the medical benefit. For many years, South Africa has been a mass importer of API’s with as much as 90% of APIs used in 2018 coming from foreign markets (mainly China and India). APIs make up 50-60% of the total manufacturing cost, so producing API’s in South Africa provides major benefits. In 2015, CPT Pharma broke ground on a pilot plant to prove that APIs could be successfully produced locally on a commercial scale. Construction of the pilot plant was completed in 2017 and CPT Pharma has since received Good Manufacturing Practice (GMP) approval by the South African Health
Products Regulatory Authority (SAHPRA) for the manufacturing of four APIs. “CPT Pharma was identified as an ideal partner for TIA’s intentions to support development and commercialisation of technologies to enable local API manufacturing. The success to date has also positioned the company as a key partner in ongoing collaboration initiatives within the National System of Innovation to stimulate the local pharmaceutical industry,” says Dr Vuyisile Phehane, Executive: Bioeconomy at TIA. FULLY LICENCED In August, CPT announced that it had achieved a major milestone when it was granted a licence by the SAHPRA to manufacture APIs for human medicine. “We are honoured as a company at being able to take the lead in advancing the South African
Pharma pilot plant
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