EMZOR to begin local manufacture of active pharmaceutical ingredients
Emzor has reached an API Manufacturing Technology Transfer and Licensing Agreement with India’s Mangalam Drugs & Organics Limited to locally manufacture in Nigeria and distribute Active Pharmaceutical Ingredients (APIs) for the treatment and prevention of malaria.
The arrangement includes an API technology transfer and licensing agreement which establishes a co-development basis for manufacturing four APIs for the treatment of malaria which continues to be a leading cause of death on the African continent.
This will lead to the development of a world-class API manufacturing facility in full compliance with international standards and the first of its kind in the sub-Saharan African region.
The agreement reaffirms Emzor’s longstanding commitment to strengthening the pharmaceutical sector in Africa. The signed technology transfer and licensing agreement with Mangalam, a leading Indian chemical manufacturing company will provide in-house developed technology for manufacturing antimalarial Active Pharmaceutical Ingredients (APIs).
As part of the agreement, Mangalam will also provide consultation and relevant designs for setting up a world-class API manufacturing facility 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 therapies 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 highest 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 anti-malarial and this continued focus and strategy builds on Emzor’s strength in maternal and child health. It cements the firm’s commitment to impacting the therapeutic areas that have the greatest impact on this vulnerable segment of society.
The agreement represents an excellent opportunity for local manufacturing and backward integration which supports the firm’s vision to reduce the cost of drugs and the supply chain issues often affecting the distribution and global response, particularly in times of crises as has been recently experienced with the COVID-19 pandemic.
Additionally, this agreement with Mangalam is an apt response to the complete dependency on external firms for APIs to sustain the regional pharmaceutical industry.
The successful launch of such an undertaking will require other collaborations, so with that, we are also proud to partner with API For Africa (APIFA). APIFA is a not-for-profit organization facilitating the local production of APIs in sub-Saharan Africa.
Stella C. Okoli, Emzor’s founder and managing director said “We give God all the glory and praise Him for this great privilege and opportunity to serve Nigerians, Africans and humanity. This deal is exciting for us as it provides Emzor with an opportunity to become a leader in the global fight against malaria and lends to our tireless commitment to bring affordable drugs for all,” Okoli said.
She also said that the agreement is not just a victory for Emzor; but for Nigeria. “In time we will drive the expansion of our national chemical industries, provide opportunities to utilize the petrochemical industry for making key starting intermediates, create local jobs and reduce the cost of drugs to those that need it the most.”
Emzor has begun the journey to self-reliance and sustainability of the pharma sector in Africa. This will enhance the ability to respond in times of global emergencies.