A pilot plant for the manufacture of generic active pharmaceutical ingredients (APIs) has been officially opened in Pretoria. A R50-million joint project between local company CPT Pharma (CPT standing for Chemical Process Technologies), the Industrial Development Corporation (IDC) and the Technology Innovation Agency (TIA), the programme also enjoys the support of the departments of Science and technology, Trade and Industry and Health.

APIs are crucial components in the manufacture of pharmaceuticals. One or more APIs, combined with nonactive ingredients, are used to make pharmaceuticals. Hitherto, all APIs used by local pharmaceutical companies have been imported into the country, mainly from India and China.

“We believe this is a small but significant step in the establishment of a South African API manufacturing industry,” affirmed CPT MD Dr Hannes Malan in his address. He observed that a benefit of being late into the field of generic API production was that his company could use the latest manufacturing technology while the established producers were heavily invested in older technologies. Also, in China, stricter environmental and safety regulations, and stricter enforcement of these rules, were raising the prices of Chinese products. As a result of these factors, CPT knew that its products would be competitive. “We do have the resources in South Africa to participate in the global pharma industry,” he highlighted.

TIA CEO Barlow Manilal described the new pilot plant as a “great achievement”. He emphasised that “CPT also contributed their own funding to this programme”, as well as its technical skills and capacity. He explained that, fundamentally, the TIA sought to fund the transformation of knowledge and ideas into commercial products, and, by so doing, to help develop the economy, transform it from being based on resources to be being based on knowledge and, ultimately, to improve the lives of all South Africans. “CPT ticks all these boxes . . . This is a perfect fit for TIA.” He also lauded the role of the IDC in the project. “[T]he IDC is also a very good collaborator with the TIA. The IDC played a substantially and significantly bigger role than TIA.

“Whilst China and India are the fastest-growing players, the [global pharmaceuticals][market is still dominated by the US,” he noted. “We’d like to see a South African presence [in future]. We have a fledgling pharmaceuticals industry in South Africa.” How this should be developed had to be considered.

“As the IDC, we are excited to see the project reach this stage,” asserted IDC Basic & Speciality Chemicals head Hilton Lazarus, adding that it was a “strategic project”. “CPT is an example of the role the IDC can play in setting up our own API manufacturing facilities.” Local production of APIs significantly shortens the supply chain for the South African pharmaceuticals industry, he pointed out. And the IDC expected that local API production would be expanded to commercial scale.

The technology now being used by the company to produce APIs was developed in-house. “The CPT research team . . . develop[ed] novel synthesis techniques” and a set of “competitive technology packs” for the production of APIs, highlighted company chairperson Dr Gerrit van der Klashorst. He praised the IDC and local and international industry partners for their contributions.

“This step is only a single step in the journey to build a substantial API manufacturing industry in South Africa,” he cautioned. “There is still a substantial amount of work to be done to realise a commercial plant and commercial production in South Africa.”