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Saturday, September 25, 2021

Malaria APIs: Manufacture | Treatment | Prevention

How to Launch a Brand Malaria APIs

Emzor has signed an API Manufacturing Technology Transfer and Licensing Agreement with India's Mangalam Drugs and Organics Limited to locally fabricate in Nigeria and convey Active Pharmaceutical Ingredients (APIs) for the treatment and prevention of malaria.

The course of action incorporates an API innovation move and permitting arrangement, which builds up a co-advancement reason for assembling 4 APIs for the treatment of malaria, which continues to be a main source of death on the African continent.

This will prompt the improvement of an elite API fabricating office in full compliance with worldwide standards and the first of its kind in the sub-Saharan African region.

The arrangement reaffirms Emzor's long-standing commitment to strengthening the pharma sector in Africa. The marked technology transfers and licensing agreement with Mangalam, a leading Indian substance manufacturing company, will provide in-house developed technology for manufacturing antimalarial Active Pharmaceutical Ingredients (APIs).

As part of the arrangement, Mangalam will also provide consultation and relevant plans for setting up an elite API manufacturing office compliant with WHO standards. The initial focus will be on the development of 4 APIs: artemether, lumefantrine, sulfadoxine, and pyrimethamine.

The selected APIs provide chemo-preventive combination treatments for malaria in pregnant women as well as treatment for adults and children. Malaria remains the leading cause of death in Nigeria.

According to the 2020 World Malaria Report, Nigeria had the largest number of global malaria cases (27% of global malaria cases) in 2019 and accounted for the highest number of deaths (23% of global malaria deaths).

Emzor is a pioneer in the Nigerian malaria space and was the first Nigerian indigenous pharmaceutical company to develop and manufacture artemether/lumefantrine, under the brand name Lokmal, launched in 2009.

Artemether/Lumefantrine is a WHO-recommended Artemisinin Combination Therapy (ACT). Maldox is Emzor's brand name for its sulfadoxine and pyrimethamine (S/P) combination antimalarial.

Emzor is at an advanced stage in the process of submitting a dossier to WHO prequalification for Maldox, a project supported by Medicines for Malaria Venture (MMV) with funding from UNITAID.

Emzor currently manufactures 19 SKUs of antimalarials, and this continued focus and strategy build on Emzor's strength in maternal and child health. It solidifies the company's commitment to impacting the therapeutic areas that most greatly affect this vulnerable segment of society.

The arrangement addresses a remarkable opportunity for local manufacturing and backward integration, which supports the company's vision to reduce the cost of medications and the supply chain issues often affecting distribution and global response, especially in the midst of crises such as the COVID-19 pandemic.

Moreover, this agreement with Mangalam is a timely response to the total reliance on external firms for APIs to support the regional pharmaceutical industry.

The successful launch of such an initiative will require various collaborations, so we are also pleased to partner with API For Africa (APIFA), a non-profit organization working on local API production in sub-Saharan Africa.

Dr. Stella C. Okoli, Emzor's Founder and Managing Director, said, "We give God all the glory and praise Him for this great opportunity to serve Nigerians, Africans, and humanity.

This arrangement is exciting for us as it gives Emzor a chance to become a leader in the global fight against malaria and contributes to our strong commitment to bringing affordable medicines for all.

The arrangement is not just a victory for Emzor; by being able to manufacture at this level locally, in time, we will drive the expansion of our national chemical industries, provide opportunities to utilize the petrochemical industry for creating key starting intermediates, create local jobs, and reduce the cost of medications for those who need it the most.

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