Zydus Lifesciences bags WHO prequalification nod for Miltefosine formulation, API to treat Leishmaniasis

Ahmedabad: Zydus Lifesciences Limited has announced that the Company has received the World Health Organisation (WHO) prequalification approval for the API and formulation of the key drug to treat Leishmaniasis, ‘Miltefosine’. With this, Miltefosine will be added to WHO’s pre-qualification list which will enable larger access to the drug globally.

Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of infected female phlebotomine sandflies. The disease affects some of the world’s poorest people and is associated with malnutrition, population displacement, poor housing, a weak immune system and lack of financial resources.

According to WHO, there are three main forms of the disease: cutaneous leishmaniasis (CL), visceral leishmaniasis (VL), also known as kala-azar, and mucocutaneous leishmaniasis (MCL). CL is the most common form, VL is the most severe form and MCL is the most disabling form of the disease. VL if left untreated, causes death in more than 90% of cases. An estimated 700 000 to 1 million new cases and an estimated 30 000 new cases of VL occur annually.

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In 2018, 92 and 83 countries or territories were considered endemic for, or had previously reported cases of, CL and VL, respectively. Today, more than 1 billion people live in areas endemic for leishmaniasis and are at risk of infection. 

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Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.

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