Anti-Malarial APIs
Life-Saving Active Pharmaceutical Ingredients for Malaria Prevention and Treatment
About Anti-Malarial APIs
Holiness Pharmaceutical is committed to fighting malaria through the manufacture and export of high-quality Anti-Malarial APIs. Our portfolio includes artemisinin-based derivatives and combination therapy components manufactured under WHO-GMP standards. We supply pharmaceutical companies globally, particularly in malaria-endemic regions, supporting public health initiatives and ensuring access to effective malaria treatments that save lives.
Key Features
- WHO-GMP certified anti-malarial manufacturing
- Compliance with WHO prequalification requirements
- Artemisinin-based combination therapy (ACT) components
- Advanced purification technology for high purity
- Comprehensive stability testing in tropical conditions
- WHO and IH (Indian Homeopathy) specifications
- Complete regulatory documentation for global markets
- Support for WHO-recommended treatment protocols
Application Areas
Uncomplicated Malaria
First-line treatment for Plasmodium falciparum and other malaria species
Severe Malaria
Injectable formulations for complicated malaria cases requiring urgent treatment
Artemisinin Combination Therapy (ACT)
Partner drugs for WHO-recommended combination treatments
Malaria Prevention
Prophylactic treatment for travelers and high-risk populations
Drug-Resistant Malaria
Effective against chloroquine-resistant and multidrug-resistant strains
Quality Assurance
Our anti-malarial APIs undergo rigorous quality testing including HPLC analysis for potency and purity, specific identity tests, related substances testing, residual solvent analysis, heavy metal testing, and comprehensive microbiological evaluation. We conduct stability studies under Zone IV conditions (30°C/75% RH) relevant to tropical climates where these medicines are used.
Our Anti-Malarial APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Artemether API | 71963-77-4 | IH/IP/USP | API Powder | View Product |
Artesunate API | 83507-69-1 | IH | API Powder | View Product |
Lumefantrine API | 82186-77-4 | USP | API Powder | View Product |
Quinine Sulphate API | 207671-44-1 | IP/BP/EP/USP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Malarial APIs?
Anti-Malarial APIs are active pharmaceutical ingredients used to prevent and treat malaria, a mosquito-borne infectious disease. They include artemisinin derivatives (artemether, artesunate), quinoline compounds (quinine), and combination therapy partners (lumefantrine) that work by killing the malaria parasite (Plasmodium) in the bloodstream.
Which anti-malarial APIs does Holiness Pharmaceutical manufacture?
We manufacture Artemether, Artesunate, Lumefantrine, and Quinine Sulphate. Our artemisinin-based APIs meet WHO specifications and are suitable for developing artemisinin-based combination therapies (ACTs) recommended by WHO for malaria treatment.
What are Artemisinin-based Combination Therapies (ACTs)?
ACTs combine an artemisinin derivative (fast-acting but short half-life) with a partner drug (longer-acting). This provides rapid parasite clearance and prevents recrudescence. Common combinations include Artemether-Lumefantrine and Artesunate combinations. WHO recommends ACTs as first-line treatment for uncomplicated falciparum malaria.
Do your anti-malarial APIs meet WHO prequalification standards?
Yes, our anti-malarial APIs are manufactured to meet WHO prequalification program requirements. We provide complete documentation including manufacturing process details, analytical methods, stability data under tropical conditions, impurity profiles, and GMP certificates required for WHO assessment and global procurement programs.
How do you ensure stability in tropical climates?
We conduct comprehensive stability studies under ICH Zone IVb conditions (30°C/75% RH) representing tropical environments where anti-malarials are primarily used. Products are packaged in moisture-barrier aluminum foils or HDPE containers with proper sealing. Stability data supports shelf life in challenging climatic conditions.
Can you supply anti-malarial APIs for pediatric formulations?
Yes, we supply APIs suitable for pediatric formulations including dispersible tablets and oral suspensions. We provide particle size specifications, taste-masking guidance, and formulation support for child-friendly dosage forms. Our products support WHO-recommended pediatric dosing guidelines.
What is the source of your artemisinin derivatives?
Our artemisinin derivatives are synthesized through chemical processes from artemisinin or produced via semi-synthetic routes ensuring consistent quality and purity. We maintain strict quality control throughout synthesis, including stereochemistry verification and peroxide content testing critical for antimalarial activity.
Do you support global health initiatives for malaria eradication?
Yes, we actively support global malaria control programs by ensuring affordable, quality-assured anti-malarial APIs for endemic countries. We work with international organizations, participate in pooled procurement mechanisms, and provide technical support to manufacturers developing accessible malaria treatments for underserved populations.