NEW DELH: Anuh Pharma, a Mumbia-based pharma firm has secured prequalification approval from the World Health Organization (WHO) for its anti-malarial active pharmaceutical ingredient (API), Amodiaquine Hydrochloride, a development expected to strengthen the company’s presence in global malaria-control programmes and international public health procurement systems.
The approval, announced through a regulatory filing, is being viewed as a significant achievement for the Mumbai-based pharmaceutical manufacturer, particularly as countries continue to rely on quality-assured anti-malarial medicines to combat the disease burden across low- and middle-income regions.
Amodiaquine Hydrochloride is listed among the WHO’s essential medicines and is widely used in combination therapies for treating uncomplicated Plasmodium falciparum malaria, one of the most severe and potentially fatal forms of malaria worldwide.
The WHO prequalification programme evaluates medicines, vaccines and diagnostic products for their quality, safety and efficacy, ensuring that they meet internationally accepted standards. Products receiving this certification become eligible for procurement by United Nations agencies, governments and global public health organisations.
Industry observers note that WHO prequalification is regarded as a critical benchmark for pharmaceutical companies aiming to participate in international healthcare supply chains and disease-control initiatives funded by global agencies.
The approval follows another important regulatory milestone for the company. Recently, Anuh Pharma successfully completed an inspection by the United States Food and Drug Administration (USFDA), reaffirming compliance with stringent international manufacturing standards.
In another regulatory development last year, the company received a Certificate of Suitability from European authorities for Sulfadimethoxine, an antibiotic bulk drug, further strengthening its regulatory profile in overseas markets.
Exports continue to account for a substantial share of the company’s business operations. Company data show that exports contributed nearly 55% of total revenue during the financial year 2024–25.
Anuh Pharma currently maintains marketing partnerships with nearly 360 customers across more than 59 countries, including key markets in Europe, Mexico and South Africa. During the nine-month period ending December 2025, the company reported revenues of around USD 62 million.
Public health experts point out that access to affordable, reliable and quality-certified anti-malarial medicines remains central to global malaria elimination strategies. According to WHO estimates, malaria continues to affect millions of people every year, particularly across parts of Africa and Asia, making uninterrupted supply of effective anti-malarial medicines essential for disease control.
However, malaria continues to remain endemic in tribal, forested and hilly regions, particularly in states such as Chhattisgarh, Odisha, Jharkhand and parts of the Northeast.
The government has intensified surveillance, vector-control measures and access to treatment as part of its target to eliminate malaria by 2030. In this context, pharmaceutical manufacturers capable of supplying internationally certified anti-malarial ingredients are expected to play a crucial role in supporting both domestic and global public health programmes.
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