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Anuh Pharma has received prequalification approval from World Health Organization (WHO) for anti-malarial active pharmaceutical ingredient (API) amodiaquine hydrochloride USP, the company said in its filing with the stock exchanges.
Amodiaquine hydrochloride is an essential medicine listed by the WHO and widely used in combination therapies for the treatment of uncomplicated plasmodium falciparum malaria, the filing said.
This approval further consolidates Anuh Pharma's position as a preferred API supplier for global anti-malarial programmes.
The WHO Prequalification Programme evaluates the quality, safety, and efficacy of medical products—including medicines, vaccines, and diagnostics—to ensure they meet international standards and in turn aids UN agencies and countries in procuring reliable health products.
It may be recalled that the company had recently completed its US FDA inspection successfully and last year had received Certificate of Suitability from the European drug regulator for sulfadimthoxine – an antibiotic bulk drug.
The company, which derived around 55 per cent of its revenue from exports in the financial year 2024-25 (Apr-Mar), has strong marketing partnerships with 360 customers in over 59 countries including Europe, Mexico and South Africa and has reported revenue of USD 62 million for the nine-month period ended in December 2025.
As one of the largest manufacturers of macrolides and anti-TB products in India, besides being a major player in anti-bacterials, anti-malarial, anti-hypertension and corticosteroids, Anuh Pharma employs over 2,000 people across its business including manufacturing facility at Tarapur on the outskirts of Mumbai, trading, distribution and logistics among others.
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