PRIMAQUINE PHOSPHATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	PRIMAQUINE	primaquine phosphate	TABLET;ORAL	008316	NDA	Sanofi-Aventis U.S. LLC	0024-1596-01	100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01)	2011-04-15
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043	ANDA	AvKARE	42291-510-01	100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01)	2019-02-21
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043	ANDA	Ingenus Pharmaceuticals, LLC	50742-191-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01)	2018-01-23
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043	ANDA	Ingenus Pharmaceuticals, LLC	50742-191-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05)	2018-01-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Overview of Primaquine Phosphate

Primaquine phosphate is an antimalarial medication primarily used to target the dormant liver forms (hypnozoites) of Plasmodium vivax and Plasmodium ovale, and to prevent relapse. It is a derivative of quinoline and has been pivotal in malaria eradication efforts worldwide. Given its critical role, a robust supply chain comprising reputable manufacturers and dedicated suppliers is essential to ensure global availability, especially in malaria-endemic regions.

Global Manufacturers of Primaquine Phosphate

Multiple pharmaceutical companies and chemical suppliers synthesize and distribute primaquine phosphate, often under strict regulatory standards. The primary suppliers can be categorized into established pharmaceutical firms producing finished dosage forms and chemical manufacturers providing bulk active pharmaceutical ingredients (APIs).

Leading Suppliers and Manufacturers

1. Sigma-Aldrich (Merck KGaA)

Sigma-Aldrich is a major supplier of active pharmaceutical ingredients, including primaquine phosphate, serving research and pharmaceutical production globally. As a division of Merck KGaA, the company supplies APIs to drug manufacturers, often adhering to cGMP standards. Their primaquine phosphate APIs are used in both pharmaceutical formulations and research.

Products: Primaquine phosphate bulk powder, with detailed specification sheets, purity levels typically exceeding 98%, compliant with pharmacopoeial standards.

2. GlaxoSmithKline (GSK)

GSK, historically involved in producing antimalarial agents, has, in the past, manufactured pharmaceutical formulations of primaquine. While primarily a pharmaceutical developer, GSK's supply chain extends to sourcing and distributing APIs to authorized manufacturers under licensing agreements.

Note: GSK's distribution of primaquine phosphate in finished form remains significant in the public health sector, especially in endemic regions.

3. PHARMEX, Inc. (India)

India-based chemical manufacturer and API supplier, Pharmex offers primaquine phosphate as a raw material for pharmaceutical companies. Indian suppliers are prominent in the global supply chain due to their cost advantage and compliance with Indian pharmacopoeia standards.

Regulatory compliance: WHO-GMP certified, ISO certified, supplying to multiple markets including Africa, Southeast Asia, and South America.

4. Suncarex (China)

Suncarex is a Chinese chemical manufacturer specializing in APIs including antimalarials like primaquine phosphate. The company has grown significantly due to increasing demand from the tropical medicine sector and exports to European and African pharmaceutical companies.

Regulatory status: Gained FDA approval for specific APIs, with plans for cGMP compliance certifications to expand global access.

5. EIPICO (Egyptian International Pharmaceuticals Industries Co.)

EIPICO manufactures a wide range of pharmaceutical APIs, including primaquine phosphate, primarily for the Middle East and African markets. The company adheres to European and Egyptian GMP standards.

Key Considerations in Supplier Selection

Regulatory Compliance: Suppliers should adhere to cGMP standards, hold relevant certifications (FDA, EMA, WHO), and have a proven track record of quality assurance.
Quality Assurance: Consistency in API quality, high purity levels, and adherence to pharmacopoeial standards.
Supply Capacity: Ability to meet global demand, especially during malaria outbreaks or high-demand seasons.
Pricing and Lead Times: Competitive pricing balanced with reliable delivery schedules.
Geographical Accessibility: Proximity to key markets can influence distribution efficiency. Suppliers in India and China are prominent due to manufacturing scale and cost-effectiveness.
Regulatory Approvals: Suppliers with approved manufacturing facilities from major health authorities facilitate faster market entry.

Manufacturing Challenges in Primaquine Phosphate Supply Chain

Despite a relatively established supply network, challenges persist, impacting global availability:

Raw Material Scarcity: Raw materials like 4,6-Dichloro-2-Methoxyquinoline, a precursor for primaquine synthesis, can face shortages.
Regulatory Hurdles: Increasing regulatory compliance requirements pose barriers, especially for regional manufacturers seeking global access.
Intellectual Property Constraints: Although primaquine is off-patent, certain formulations or process patents may restrict production in some jurisdictions.
Quality Variability: Ensuring uniform quality remains a challenge, especially among smaller or less-regulated suppliers.

Emerging Suppliers and Market Dynamics

With the global health imperative to eliminate malaria, especially in sub-Saharan Africa, international agencies like WHO and UNICEF are working to diversify and strengthen the supply chain. Efforts include:

Pre-qualification Programs: WHO pre-qualification for APIs and formulations, providing assurance of quality.
Development of Local Manufacturing: Encouraging regional production facilities in Africa and Southeast Asia to reduce dependency on imports.
Public-Private Partnerships: Collaborations aimed at subsidizing costs and ensuring steady supply.

Regulatory and Certification Landscape

Suppliers must comply with various international standards:

WHO-GMP Certification: For suppliers exporting APIs to developing countries.
FDA and EMA Approvals: For finished products and APIs used in markets regulated by Western agencies.
ISO Certifications: Ensuring quality management systems in manufacturing processes.

Adherence to these is vital for procurement by international health agencies and large pharmaceutical firms.

Conclusion

The supply of primaquine phosphate hinges on a network of reputable manufacturers and chemical suppliers committed to quality, regulatory compliance, and capacity expansion. Indian and Chinese producers dominate the API landscape, supported by Western and Middle Eastern pharmaceutical companies for finished formulations. As malaria continues to threaten global health, strengthening supply chains through diversified manufacturing, regulatory harmonization, and regional production remains crucial.

Key Takeaways

Global suppliers of primaquine phosphate include Sigma-Aldrich, Pharmex India, Suncarex China, and EIPICO Egypt, each regulated for quality and compliance.
Regulatory adherence to WHO-GMP and regional standards is crucial for reliable procurement and distribution.
Supply chain resilience can be improved through regional manufacturing initiatives and public-private partnerships, especially in malaria-prone regions.
Emerging challenges such as raw material shortages and regulatory hurdles require proactive management to ensure uninterrupted supply.
International agencies play a crucial role in pre-qualifying suppliers and facilitating access to high-quality APIs for endemic countries.

FAQs

1. Who are the primary global manufacturers of primaquine phosphate?
Major suppliers include Sigma-Aldrich (Merck), Indian manufacturers like Pharmex, Chinese companies such as Suncarex, and Egyptian firm EIPICO, all adhering to international quality standards.

2. What quality standards should suppliers of primaquine phosphate meet?
Suppliers should comply with WHO-GMP, have ISO certifications, and meet pharmacopoeial standards (USP, EP, or BP) for purity, potency, and safety.

3. How does regional manufacturing influence the supply of primaquine?
Local or regional manufacturing reduces dependency on imports, cuts transit times, and can lower costs, improving access in malaria-endemic regions.

4. Are there any recent developments to enhance the supply of primaquine phosphate?
Yes, initiatives like WHO prequalification, development of new manufacturing facilities in Africa, and encouraging technology transfer aim to strengthen and diversify the supply.

5. What challenges threaten the continuous availability of primaquine phosphate?
Raw material shortages, stringent regulatory requirements, intellectual property issues, and quality variability are primary concerns impacting supply stability.

Sources:

[1] World Health Organization. Prequalification of Medicines Programme.
[2] U.S. Food and Drug Administration. Drug Master Files.
[3] Indian Pharmacopoeia Commission. API Standards.
[4] Suncarex official website. Product specifications.
[5] EIPICO Corporate Brochure. API manufacturing capacity.

Suppliers and packagers for generic pharmaceutical drug: PRIMAQUINE PHOSPHATE