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Suppliers and packagers for primaquine
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primaquine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Primaquine
Introduction
Primaquine is an antimalarial agent primarily used to eradicate hypnozoites of Plasmodium vivax and Plasmodium ovale, preventing relapses of malaria. It is also employed in combating P. falciparum gametocytes and in combination therapies for malaria treatment. As a critical component of malaria eradication programs, the supply chain for primaquine is vital for global health initiatives. This article delineates the key suppliers of primaquine, examining manufacturing sources, regulatory landscapes, and market dynamics influencing its availability.
Manufacturers of Primaquine
The global supply of primaquine is predominantly controlled by several leading pharmaceutical companies and generic drug manufacturers. These entities operate across regions, including North America, Europe, Asia, and India, contributing substantially to the world's medicinal inventory.
Major Pharmaceutical Companies
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Sanofi
Previously, Sanofi distributed primaquine through its malaria portfolio, notably under the brand “AlQuin®”. Although Sanofi's focus has shifted post-2010s, its historical role established it as a significant supplier. Sanofi’s manufacturing processes adhere to stringent WHO and GMP standards, ensuring high-quality production. -
GSK (GlaxoSmithKline)
GSK has manufacturing plants capable of producing primaquine. In certain markets, GSK supplies PRIMAQUIN as part of their malaria control portfolio, emphasizing quality control and compliance with international regulatory standards. -
Sanofi-Aventis
Operating globally, Sanofi-Aventis has historically been involved in supplying primaquine, often targeting endemic regions with high malaria prevalence. Their production is compliant with global safety and efficacy standards.
Leading Generic Manufacturers
Given the expiration of patents at various points, many generic drug manufacturers now produce primaquine, enhancing global supply and affordability.
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Macleods Pharmaceuticals (India)
Macleods is among the prominent producers of primaquine tablets, leveraging India’s robust generic pharmaceutical sector. Their products are WHO prequalified and approved by regulatory agencies, facilitating distribution in endemic regions. -
Cadila Healthcare (Zydus Cadila)
Zydus Cadila manufactures primaquine as part of its antimalarial portfolio. It maintains ISO and WHO GMP certifications, ensuring quality standards. -
Strides Pharma Science
With manufacturing facilities specializing in antimalarials, Strides Pharma supplies primaquine in various formulations to both domestic and international markets. -
Alvogen
Alvogen produces generic primaquine for multiple territories, adhering to regulatory and quality standards, often serving the Americas and Asia. -
Farmanguinhos (Fiocruz, Brazil)
As part of Brazil’s public health system, Farmanguinhos manufactures primaquine to supply the Latin American region, particularly under government procurement programs.
Chinese and Indian Producing Facilities
In addition, several Chinese pharmaceutical manufacturers produce primaquine tablets and active pharmaceutical ingredients (API). Companies such as Hunan Dongting Pharmaceutical and Zhejiang Australian Pharmaceutical Co. have capacities capable of supplying API, which is then formulated into tablets by local generics producers.
Regulatory and Quality Standards
For a drug like primaquine, regulatory approval and adherence to WHO prequalification programs are crucial. Many manufacturers seek WHO prequalification to secure procurement contracts from global health organizations, including the Global Fund and UNICEF.
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WHO Prequalification
Companies like Macleods and Zydus have successfully obtained WHO prequalification for primaquine, ensuring their products meet international safety, efficacy, and quality benchmarks [1]. -
FDA and EMA Approvals
In developed markets, approval by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) further validates manufacturer credentials, expanding their market reach.
Market Dynamics and Supply Chain Considerations
The supply landscape for primaquine remains influenced by several factors:
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Patent and Regulatory Exclusivity
Patent expirations have enabled numerous generic manufacturers to enter the market, increasing supply and lowering prices. However, some formulations may still be under patent protection, limiting certain formulations to specific suppliers. -
Manufacturing Capacity and Quality Assurance
The ability of manufacturers to scale production to meet global demands hinges on their GMP compliance, API sourcing, and capacity expansion investments. -
Global Health Initiatives
Procurement through agencies like WHO’s Global Malaria Programme and the Clinton Health Access Initiative (CHAI) promotes standardized purchasing, fostering a diversified supplier base. -
Geopolitical Factors
Trade policies, tariffs, and regional regulations influence supply routes. For instance, import restrictions in certain countries may impact available sources.
Key Challenges in Primaquine Supply
Despite multiple suppliers, challenges persist:
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API Shortages
Disruptions in API manufacturing, especially in regions with geopolitical instability or supply chain disruptions, can lead to shortages. -
Formulation Constraints
Primaquine's chemical stability necessitates specific formulation practices, restricting production options to manufacturers with adequate expertise. -
Quality Variability
The proliferation of low-cost generics, particularly from unregulated markets, raises concerns regarding potency, safety, and efficacy, emphasizing the importance of WHO prequalification.
Emerging Trends and Future Outlook
The demand for high-quality primaquine suppliers is poised to grow, aligned with increased global malaria eradication initiatives. Advances in manufacturing technology and regulatory harmonization are likely to expand the pool of certified suppliers further. Additionally, efforts to develop long-acting formulations or combination therapies may influence future manufacturing strategies and supply channels.
Key Takeaways
- Multiple global manufacturers, including Sanofi, GSK, Macleods, Zydus Cadila, and others, supply primaquine, with a significant presence of Indian and Chinese producers.
- WHO prequalification remains a critical marker for supplier credibility and global procurement acceptance.
- The market is increasingly diversified due to patent expirations, fostering competitive pricing and supply stability.
- Supply chain resilience hinges on manufacturing capacity, API availability, quality assurance, and geopolitical stability.
- Ensuring quality standards and adherence to regulatory approvals remains essential for safe and effective primaquine distribution.
FAQs
1. Who are the leading global suppliers of primaquine?
Major suppliers include Sanofi, GSK, Macleods Pharmaceuticals, Zydus Cadila, and Strides Pharma. Many Indian and Chinese generic manufacturers also produce primaquine to meet global demand.
2. Is primaquine available as an API or only in finished formulations?
Both APIs and finished dosage forms are available. API production is primarily done by manufacturers in India and China, which are then formulated into tablets by generic producers.
3. How does WHO prequalification influence supplier selection?
WHO prequalification certifies that a manufacturer’s primaquine meets international safety, efficacy, and quality standards, making it eligible for procurement by global health organizations.
4. Are there concerns regarding the quality of primaquine in the market?
Yes. While many suppliers adhere to strict standards, low-cost generics from unregulated markets may present variability in potency and safety, underscoring the importance of selecting WHO-prequalified products.
5. What factors affect the future availability of primaquine?
Manufacturing capacity, API supply stability, regulatory environment, and geopolitical factors will influence the future availability of high-quality primaquine globally.
References
[1] World Health Organization. WHO Prequalification of Medicinal Products: Primaquine. Available at: [WHO PQ website].
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