MGC Pharma Ltd (LON:MGC, ASX:MGC) said it was granted approval by the Indian authorities to import its phytomedicine CimetrA into the country.
The company said the green light represented a “final step” towards obtaining emergency-use authorisation for the treatment of patients with Coronavirus (COVID-19).
MGC’s co-founder and managing director, Roby Zomer, said: "We are pleased to have secured a license to import CimetrA as an Emergency Use Drug in India, and hope that we can secure approval swiftly to expand its availability to a much wider patient base.
"India has been acutely affected by the COVID-19 pandemic and we believe that CimetrA can make an important difference in treating the symptoms of COVID-19 and alleviate patient suffering.”
In the same announcement, it said it had appointed Medopharm, one of the country's leading pharma manufacturers, to import and market the treatment.
“It is important that we have secured Medopharm, as the importer and the marketing authorisation holder of CimetrA given their vast experience of taking medicinal products through the process to full approval for sale,” Zomer added.
To meet the potentially significant increase in demand, MGC said it has secured agreements for two additional production facilities. They will be used to generate “large commercial quantities” of CimetrA until the firm's Malta production operation completes is fully operational in 2022, investors were told.
CimetrA is a nanoparticle formulation based on the spice Curcumin and the plant extract Boswellia that is thought to have has anti-inflammatory and immuno-modulating effects.
Israeli researchers are currently overseeing a phase III COVID-19 trial using the MGC treatment.