Strides Pharma Kenya based arm bags WHO certification to produce antimalarial drug

Universal Corporation's pre-qualification was achieved with funding from global health agency Unitaid and support from MMV.

Published On 2022-08-27 06:17 GMT   |   Update On 2022-08-27 06:17 GMT
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New Delhi: Strides Pharma Science has recently announced that Universal Corporation Ltd (UCL), a Kenya-based subsidiary of the company has received a quality certification from the World Health Organization (WHO) to produce key antimalarial drug used to prevent infection in pregnant women and children.

"Called prequalification, this certification will enable Kenyan manufacturer UCL to support regional efforts to combat malaria through local production of high-quality sulfadoxine-pyrimethamine (SP)," the company stated in a release.

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UCL's pre-qualification was achieved with funding from the global health agency Unitaid and support from MMV.

Pre-qualification is a service provided by WHO to assess the quality, safety, and efficacy of medicinal products.

Quality assurance of UCL's Sulfadoxine-pyrimethamine 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.

"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. Reinforcing local production of medicines where they are needed most is critical to building stronger and more resilient health responses," said Dr. Philippe Duneton, Executive Director of Unitaid.

Young children and pregnant women are among the most vulnerable to the burden of malaria, with children under five accounting for 80% of all malaria deaths in Africa. Sulfadoxine-pyrimethamine is a generally well-tolerated, effective, and affordable medicine used to prevent malaria, yet adequate delivery and scale-up of these interventions are hampered in part by inadequate and unstable supply and, until now, have completely relied on imported or poor-quality drugs.

"UCL is committed to supplying the African continent with quality medicines that are most needed by the people who live here. 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," said Perviz Dhanani, Founder and Managing Director of UCL.

The lack of pre-qualified manufacturers in Africa raises concerns about the quality of medicines and supply insecurities that compromise the treatment of chronic and infectious diseases – risks that were clearly revealed when COVID-19 disrupted global supply chains and left Africa with limited access to vital products. 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 the global production of medicines. Increased supply of 
sulfadoxine-pyrimethamine
 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. With Unitaid funding, MMV is working to strengthen global supply chains and support the appropriate use of quality medicines critical to the malaria response.
"Researchers and manufacturers from the countries hardest hit by malaria must be at the forefront of efforts to defeat the disease, which is why we welcome this wonderful news," said David Reddy, MMV's CEO. "We congratulate Universal Corporation Ltd for becoming the first African manufacturer to receive WHO pre-qualification for SP for the prevention of malaria in pregnant women and infants and are delighted to have partnered with them in this effort."

Read also: Strides Pharma secures USFDA nod for pain relief drug

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