Zydus Lifesciences achieves WHO prequalification for Leishmaniasis treatment, Miltefosine


Zydus Lifesciences Limited, a prominent player in the pharmaceutical industry, has achieved a significant milestone in global healthcare by receiving the World Health Organization (WHO) prequalification approval for the active pharmaceutical ingredient (API) and formulation of Miltefosine, a key drug in the treatment of Leishmaniasis. This approval marks a pivotal moment, as Miltefosine will now be included in WHO’s pre-qualification list, significantly enhancing global access to this vital medication.

Leishmaniasis, a disease caused by protozoan parasites transmitted through the bite of infected female phlebotomine sandflies, poses a significant health risk in some of the world’s poorest regions. The disease is closely linked with various socio-economic factors including malnutrition, population displacement, substandard housing conditions, compromised immune systems, and limited financial resources. With WHO’s prequalification of Miltefosine, there is now a beacon of hope for improved treatment accessibility across the globe.

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Leishmaniasis manifests in three main forms: cutaneous (CL), visceral (VL, also known as kala-azar), and mucocutaneous (MCL), with VL being the most severe form that can lead to death in over 90% of untreated cases. The disease’s prevalence is staggering, with an estimated 700,000 to 1 million new cases annually and around 30,000 new cases of VL. As of 2018, 92 and 83 countries or territories were considered endemic for CL and VL, respectively, highlighting the extensive global challenge posed by this disease. More than 1 billion people currently live in areas at risk of leishmaniasis infection.

Zydus Lifesciences achieves WHO prequalification for Miltefosine, Leishmaniasis treatment

Zydus Lifesciences achieves WHO prequalification for Miltefosine, Leishmaniasis treatment

The WHO prequalification of Zydus Lifesciences Limited’s Miltefosine is a crucial development in the fight against leishmaniasis. This approval not only underscores the company’s commitment to addressing global health challenges but also ensures that Miltefosine can be more readily accessed by those in need, particularly in endemic regions. This achievement is expected to play a significant role in controlling the spread of leishmaniasis, providing a more effective treatment option for patients afflicted by this debilitating disease.

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The WHO prequalification of Miltefosine by Zydus Lifesciences Limited represents a significant advance in the global health community’s efforts to tackle leishmaniasis. This development is a testament to the pharmaceutical industry’s capability to respond to pressing health crises and underscores the importance of global cooperation in improving access to life-saving medications. By making Miltefosine more accessible worldwide, we can expect to see a reduction in the incidence and severity of leishmaniasis, especially in the most vulnerable populations.

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The accompanying generic landscape image visually complements the narrative, symbolizing the challenges and efforts in providing healthcare and medical access to remote and impoverished regions, specifically in the context of combating diseases like Leishmaniasis.

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