South African startup pharmaceuticals company CPT Pharma, a subsidiary of Chemical Process Technologies (CPT), has received Good Manufacturing Practice approval from the South African Health Products Regulatory Authority for the manufacture of four active pharmaceutical ingredients (APIs). (CPT Pharma’s mother company, CPT, produces animal health products.) The CPT Pharma facility, in north-east Pretoria, is a pilot plant.

CPT Pharma is focused on the production of active pharmaceutical ingredients (APIs), which form the basis of medication. API producers supply their molecules to pharmaceuticals companies that then use them to produce medicines. Different APIs are combined in different ratios and quantities to produce different medicines. (Of course, the major global pharmaceuticals companies produce both APIs and medicines.)

“We’ve received approval to manufacture four specific molecules, which we have developed the technology for,” explains CPT (and CPT Pharma) MD Hannes Malan. “Until now, we’ve been producing test batches but now we will be able to produce them commercially as well. Getting these approvals was one of the highest hurdles we had to cross; this is a highly regulated industry, which makes it expensive, so it’s not an easy sector to work in and the regulatory pace can be slow. These approvals show we’re doing the right thing and we’re doing it properly.”

For the manufacture of these APIs, the company is using technology that it has developed itself. This has now proven to be market competitive in terms of both quality and price. It is the use of locally developed technology that allows CPT Pharma’s South Africa-made APIs to be competitive with those imported from India and China. Previously, it had been thought that the competitive manufacture of APIs in South Africa was impossible. “We’ve shown that, if you have competitive technology, it can be done,” he emphasises.

The CPT Pharma facility was formally opened in November 2017 and the venture is supported by the Industrial Development Corporation (IDC) and has received assistance from the Technology Innovation Agency (TIA). “We’ve had good support from the IDC. We couldn’t have achieved what we have without them,” he stresses. “TIA also made an important contribution.”

“This is helping create an entire industry in South Africa,” highlights CPT financial director (and CPT Pharma financial manager) Anton Steyl. “The Covid-19 pandemic has shown how unwise it is to be too dependent on critical imports. This is a step towards increased self-sufficiency in South Africa. We’ve achieved this in South Africa, with South African talent, using South African manufacturers as much as possible. We are one of only two API manufacturers on the entire African continent, the other also being here in South Africa, but that belongs to an international group and so we are the only independent one.”

Pretty obviously, the focus of the company is on the production of generic APIs. These will be supplied to the local pharmaceuticals sector. Hitherto, South African pharmaceuticals companies have had to import their APIs, at a cost estimated to be around R22-billion a year. “The pharmaceuticals sector is very strong in South Africa,” points out CPT (and CPT Pharma) founder and director Gerrit van der Klashorst. “About 58% to 60% of the medicines used in South Africa are formulated here.”

“We have a long list of APIs we want to work through and will continue with the production of test batches and evaluations,” reports Malan. “The next phase will be the expansion of the pilot plant to produce APIs in scale for the local market. We’ve started the design work for the expansion of the plant. But hopefully this will only be the first phase of expansion. If the enlarged plant is a success, we’ll set up an even bigger plant. That will have to be at a new location, for our current site is too small to accommodate such a major expansion. The size of this future plant would be dependent on the number of molecules we could successfully commercialise and the size of the market.”

The company has also been developing international links. In particular, strong links are being developed with research groups and commercial companies in the US, looking for partners to produce APIs for antiretroviral drugs in Africa, to treat HIV/Aids. “Our achievements are being recognised,” notes Malan.