KENYA – The World Health Organization (WHO) has approved sulfadoxine-pyrimethamine (SP) by Kenyan manufacturer Universal Corporation Ltd (UCL) for the prevention of malaria infections in pregnant women and infants.

Universal Corporation’s sulfadoxine-pyrimethamine (SP) is a generally well-tolerated, effective and affordable medicine used to prevent malaria in pregnant women and infants hence the approval will improve local supply of the medicine used to prevent malaria across Africa.

Medicines for Malaria Venture (MMV) announced in a press release that the World Health Organization issued a quality certification to the first African manufacturer of a key antimalarial drug used to prevent infection in pregnant women and children.

Medicines for Malaria Venture said the WHO pre-qualification will enable Kenyan manufacturer Universal Corporation to support regional efforts to combat malaria through local production of high-quality sulfadoxine-pyrimethamine (SP).

The not-for-profit public-private partnership further said that Quality assurance of UCL’s SP product Wiwal® opens a route for procurement by global scale-up partners that will improve access and help strengthen Africa’s ability to combat endemic diseases.

Increased supply of SP is crucial to the long-term success of Unitaid’s malaria chemoprevention strategy, which includes nearly US$ 160 million invested to date to optimize and scale up delivery of SP through seasonal delivery and intermittent preventive treatment in pregnant women and infants.

Perviz Dhanani, Founder and Managing Director of UCL reaffirmed the manufacturing company’s commitment to supplying the African continent with quality medicines that are most needed by the people who live in the region.

We are not only the first pharmaceutical company to receive pre-qualification of sulfadoxine-pyrimethamine in Africa, but one of only five manufacturers in Africa to have received this quality certification for any product. We’re filling a much-needed gap,” Perviz Dhanani added.

Universal Corporation, a subsidiary of the Strides Pharma Science, notes that the breakthrough responds to the need for local production of quality medicines for use in Africa since the continent was completely reliant on imported quality-assured SP.

UCL’s pre-qualification was achieved with funding from global health agency Unitaid and support from Medicines for Malaria Venture as MMV is working to strengthen global supply chains and support appropriate use of quality medicines critical to the malaria response.

Unitaid welcomes the certification of UCL to produce this quality-assured antimalarial medicine in Africa, where about 95% of all illness and death from malaria occurs,” said Dr Philippe Duneton, Executive Director of Unitaid.

The Unitaid Executive Director pointed out that reinforcing local production of medicines where they are needed most is critical to building stronger and more resilient health responses, noting that young children and pregnant women are among the most vulnerable to the burden of malaria.

Furthermore, the production of quality medicines on the African continent is critical not only for the safety of Africa’s people but also for supporting regional supply availability and diversification in global production of medicines.

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