Universal Corporation Limited, a unit of Strides Pharma Science, became the first African drug manufacturer to snare a World Health Organization (WHO) pre-qualification (PDF) to produce the anti-malarial drug sulfadoxine-pyrimethamine and amodiaquine (SPAQ).
The treatment is a combination regimen used to prevent malaria in children living in areas with seasonal malaria transmission.
The WHO's pre-qualification program is designed to set standards of quality, safety and efficacy in manufacturing medicines. With the designation, Kenya-based UCL will look to boost regional production and access to essential medicines on the African continent, where about 95% of all malaria cases and 96% of deaths from malaria occur, the company said in a Nov. 6 press release.
“Universal Corporation is committed to advancing the fight against malaria and improving the health and well-being of communities across Africa,” Perviz Dhanani, founder and managing director of UCL, said in the release. “The WHO prequalification of our SPAQ production is a significant step forward in achieving these goals.”
In 2022, WHO began to recommend SPAQ for any child at high risk of severe malaria in areas with seasonal malaria transmission. This recommendation resulted in more than 48 million children being protected from malaria, significantly reducing the burden of this deadly disease, the organization said.
According to WHO, the reported cases of malaria hit 247 million in 2021, compared with 245 million in 2020 and 232 million in 2019.
In an unrelated but recent move, Strides in September said it planned to spin off its CDMO and soft gelatin businesses into a single entity that will be known as OneSource.
The goal of the spinoff, which is expected to happen in the next year, is to establish a specialty pharmaceutical CDMO company that offers services for biologics, oral softgels, complex injectables, sterile injectables and other complex drug delivery systems.