Mumbai-based Anuh Pharma has received prequalification approval from the World Health Organization (WHO) for its anti-malarial active pharmaceutical ingredient (API), Amodiaquine Hydrochloride, strengthening the company’s position in global malaria-control programmes.
The approval, disclosed in a filing to stock exchanges, marks a significant milestone for the pharmaceutical manufacturer, particularly at a time when demand for quality-assured anti-malarial medicines remains critical across several low- and middle-income countries.
Amodiaquine Hydrochloride is included in the WHO’s list of essential medicines and is widely used in combination therapies for treating uncomplicated Plasmodium falciparum malaria, one of the deadliest forms of the disease globally.
The WHO prequalification programme assesses the quality, safety, and efficacy of medicines, vaccines, and diagnostic products to ensure they meet international standards. The certification enables United Nations agencies and countries worldwide to procure trusted and reliable medical products for public health programmes.
Industry experts say WHO prequalification is considered an important benchmark for pharmaceutical companies seeking to expand their participation in international healthcare procurement systems, especially in disease-control programmes supported by global agencies.
With this latest approval, Anuh Pharma is expected to strengthen its footprint in the anti-malarial segment and deepen engagement with international health organisations and procurement networks.
The development comes close on the heels of another regulatory achievement for the company. Anuh Pharma recently completed a successful inspection by the United States Food and Drug Administration (USFDA), reinforcing compliance with international manufacturing standards.
Last year, the company also received a Certificate of Suitability from European regulators for Sulfadimethoxine, an antibiotic bulk drug, further expanding its regulatory credentials in global markets.
Anuh Pharma derives a substantial share of its business from exports. According to company data, exports contributed nearly 55% of its total revenue during the financial year 2024–25.
The company has established marketing partnerships with around 360 customers across more than 59 countries, including markets in Europe, Mexico, and South Africa. For the nine-month period ending December 2025, the company reported revenues of approximately USD 62 million.
Over the years, Anuh Pharma has emerged as one of India’s major manufacturers of macrolides and anti-tuberculosis products. It also has a significant presence in therapeutic segments such as anti-bacterials, anti-malarials, anti-hypertension medicines, and corticosteroids.
Public health experts note that access to affordable and quality-assured anti-malarial medicines remains a key component of global malaria elimination efforts. According to WHO estimates, malaria continues to affect millions annually, particularly in parts of Africa and Asia, making reliable supply chains for anti-malarial drugs essential.
India has achieved remarkable progress in malaria control, reducing cases and deaths by over 80% from 2015 to 2023, with over 122 districts reporting zero cases in 2024. The disease remains endemic, primarily in tribal and hilly areas of Chhattisgarh, Odisha, Jharkhand, and the Northeast. The country targets full elimination by 2030. India has also intensified efforts to eliminate malaria through surveillance, vector control, and improved access to treatment.
Pharmaceutical companies producing internationally certified anti-malarial ingredients are expected to play a crucial role in supporting these programmes both domestically and globally.
The WHO approval is, therefore, being viewed not only as a regulatory achievement for Anuh Pharma but also as a step that could contribute to strengthening the global supply of quality anti-malarial medicines.
