SAHPRA issues GESlabs licence to manufacture cannabinoid pharmaceutical ingredients for use in therapeutic medicines for regional and global markets.
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 brand new South African production laboratory.
GESLabs has attracted 20 million Rand of foreign direct investment and has 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 were 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 were able to collaboratively shape the design of the space to ensure that the final outcome met the exacting quality and safety standards set by their organisation and the global certification.
Peter Nel, Managing Director at GESLabs explained, “SAHPRA has been an extremely constructive partner over the last 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 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.
GESLabs is a cGMP pharmaceutical manufacturing business specializing in alkaloid and cannabinoid active pharmaceutical ingredient manufacture. Using carefully cultivated, (GACP), biomass processed through world-class technology GESLabs can deliver best-in-class active pharmaceutical ingredients for use in prescription medicines and wellness supplements.
Find out more at: www.geslabs.com