After two years of design, build, inspection, and collaboration, the South African Health Products Regulatory Authority (SAHPRA) has licenced GESLabs to manufacture cannabinoid active pharmaceutical ingredients (APIs) at its South African production laboratory.
GESLabs has attracted R20m of foreign direct investment and built a world-class pharmaceutical laboratory in Cape Town, which will serve domestic and international markets with active pharmaceutical ingredients (APIs) for use in cannabinoid medicines.
Despite being launched as the pandemic struck, the ambitious project team of local scientists, engineers and builders was able to blend, on and off-site work, to execute the construction of a world class pharmaceutical facility on time and within budget.
The company engaged with SAHPRA from the outset, sharing detailed engineering plans for the site construction and lines of operating machinery within it. SAHPRA was able to collaboratively shape the design of the space to ensure the final outcome met the exacting quality and safety standards set by their organisation and the global certification.
Peter Nel, managing director at GESLabs, said, “SAHPRA has been an extremely constructive partner over the past 18 months and found time for us despite the sudden and intense pressures they faced as the central agency for COVID-19 vaccinations. It was a hard journey, but effective regulation of cannabinoids is vital for the long-term safety and reputation of our sector.”
The relationship between SAHPRA and GESLabs is, however. far from over. The process is not a once off box ticking exercise, but a rolling partnership of compliance. Now that the governance component is firmly entrenched, monitoring and reporting will ensure standards are updated as legislation is amended. Ensuring continued efficacy of manufactured drugs is crucial for the protection of the local and international reputation of the South African pharmaceutical industry.
GESLabs will start production immediately and will ship its first sample APIs to the USA, UK, Germany and Australia in February.
Issued by GESLabs