Anuh Pharma Gets WHO Prequalification for Anti-Malarial API Amodiaquine Hydrochloride USP
Anuh Pharma Limited secured WHO Prequalification approval for Amodiaquine Hydrochloride USP, an anti-malarial Active Pharmaceutical Ingredient compliant with United States Pharmacopeia standards. The approval, disclosed on 04 May 2026 under SEBI Regulation 30, covers international markets including WHO-procured and donor-funded programmes, consolidating the company's position as a preferred global API supplier for anti-malarial treatments.

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Anuh Pharma Limited has received World Health Organization (WHO) Prequalification approval for its Active Pharmaceutical Ingredient (API), Amodiaquine Hydrochloride USP. The disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and was communicated to stock exchanges on 04 May 2026. This regulatory milestone reinforces the company's standing as a credible supplier for international anti-malarial programmes.
WHO Prequalification: A Key Regulatory Milestone
The WHO Prequalification programme is an internationally recognised certification that enables pharmaceutical manufacturers to demonstrate compliance with rigorous global quality, safety, and efficacy standards. Approval under this programme is particularly significant for APIs intended for use in public health programmes and procurement by international health agencies. The following table summarises the key details of the approved product:
| Parameter: | Details |
|---|---|
| Product Name: | Amodiaquine Hydrochloride USP (Amodiaquine HCl USP) |
| Drug Category: | Anti-Malarial API (Active Pharmaceutical Ingredient) |
| Pharmacopoeial Standard: | United States Pharmacopeia (USP) |
| Approval Body: | World Health Organization (WHO) – Prequalification Programme |
| Approval Type: | WHO Prequalification of Medicines Programme – Active Pharmaceutical Ingredient |
| Applicable Market: | International markets including WHO-procured and donor-funded programmes |
About Amodiaquine Hydrochloride USP
Amodiaquine Hydrochloride is an essential medicine listed by the WHO and is widely used in combination therapies for the treatment of uncomplicated Plasmodium falciparum malaria. As an API, it forms the active core of finished anti-malarial formulations deployed across global health programmes. The WHO Prequalification of this product by Anuh Pharma validates the company's manufacturing capabilities against stringent international benchmarks and positions it as a preferred API supplier for global anti-malarial programmes, including those funded by donor agencies.
Historical Stock Returns for Anuh Pharma
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +0.36% | +1.10% | +13.47% | -3.74% | +0.30% | -25.56% |
Which specific international donor agencies or procurement bodies like UNICEF and Global Fund is Anuh Pharma targeting for supply contracts following this WHO Prequalification approval?
How might this WHO Prequalification approval impact Anuh Pharma's revenue mix between domestic and international markets over the next 2-3 years?
Are there other APIs in Anuh Pharma's pipeline that are currently undergoing or planned for WHO Prequalification, potentially expanding their global health programme footprint?


































