Emzor announces 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 4 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 long-standing commitment to strengthening the pharma 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. The use of (S/P) in IPTp (intermittent preventive treatment of malaria in pregnancy) has been a key contributor to the reduction of maternal (and child) mortality and the negative health impact of malaria on survivors. 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. They work with a multitude of critical stakeholders (manufacturers, investors, Development Finance Institutions (DFIs), donors, governments), to address the major challenge of the lack of significant API manufacturing capacity in sub-Saharan Africa. They will be invaluable as we also seek to export some of the API production volume to other African pharmaceutical manufacturers of finished products. Dr Stella 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 an opportunity to become a leader in the global fight against malaria and lends to our tireless commitment to bring affordable drugs for all. The agreement 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 making key starting intermediates, create local jobs and reduce the cost of drugs to those that need it the most. However, most importantly we begin the journey to self-reliance and sustainability of the pharma sector in Africa and enhance our ability to respond in times of global emergencies.”
Emzor is a privately owned indigenous pharmaceutical company founded in 1984 by Dr Stella Okoli. The Company has grown into a legacy pharmaceutical company with 4 modern factories that manufacture over 140 world-class pharmaceutical products, such as analgesics (the widely used Emzor Paracetamol), vitamins, haematinics, anti-malarial, anti-tussive, antibiotics, antihelminthic, anti-histamine, antacid, and cardio-protective drugs. Emzor has a network of over 120 distributors covering public and private institutions across West Africa.
About Mangalam Drugs & Organic Limited
Mangalam commenced its manufacturing of Active Pharmaceutical Ingredients (APIs) and Intermediates at VAPI – Gujarat in 1977. It has a multi-product manufacturing facility on two locations, and an in-house Research & Development laboratory recognized by the Department of Scientific & Industrial Research, Delhi Govt. of India (DSIR). Over the last three decades, Mangalam has acquired worldwide reputation as a single stop destination for frontline Antimalaria APIs including Pyrimethamine, Sulfadoxine, Artemether, and Lumefantrine. It is a WHOGENEVA GMP Certificated facility and EDQM approved for its API manufacturing plant. It also has an agreement in place with the prestigious Clinton Health Access Initiatives (CHAI) under its Fight Malaria Program for supply of anti-malaria APIs worldwide.
About Medicines for Malaria Venture (MMV)
MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and facilitating delivery of new, effective and affordable antimalarial drugs.
About API for Africa (APIFA)
APIFA is a not for profit platform that works in partnership with local pharmaceutical manufacturers in sub-Saharan Africa to develop manufacturing capacity for Active Pharmaceutical Ingredients (APIs) and other related services. APIFA believes in the development of a thriving African pharmaceutical manufacturing industry and the employment, skill-building and positive spill over effects that would come with that, but more importantly, a resilient and stable health system and future economic growth.