Suppliers and packagers for PLAQUENIL

PLAQUENIL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Advanz Pharma	PLAQUENIL	hydroxychloroquine sulfate	TABLET;ORAL	009768	NDA	Advanz Pharma (US) Corp.	59212-562-10	100 TABLET in 1 BOTTLE (59212-562-10)	2013-06-28
Advanz Pharma	PLAQUENIL	hydroxychloroquine sulfate	TABLET;ORAL	009768	NDA	Advanz Pharma (US) Corp.	59212-562-11	100 TABLET in 1 BOTTLE (59212-562-11)	2013-06-28
Advanz Pharma	PLAQUENIL	hydroxychloroquine sulfate	TABLET;ORAL	009768	NDA	Advanz Pharma (US) Corp.	59212-562-60	60 TABLET in 1 BOTTLE (59212-562-60)	2013-06-28
Advanz Pharma	PLAQUENIL	hydroxychloroquine sulfate	TABLET;ORAL	009768	NDA	Proficient Rx LP	71205-448-12	12 TABLET in 1 BOTTLE (71205-448-12)	2013-06-28

Suppliers for the Pharmaceutical Drug: PLAQUENIL

Last updated: August 1, 2025

Introduction

Plaquenil (hydroxychloroquine) remains a widely recognized antimalarial and immunomodulatory agent, fundamentally used in the treatment of malaria, lupus erythematosus, and rheumatoid arthritis. The global demand for hydroxychloroquine surged dramatically during the COVID-19 pandemic, spotlighting the critical importance of reliable suppliers. This report provides a comprehensive analysis of current suppliers, emphasizing manufacturing capabilities, regulatory compliance, and supply chain resilience vital for stakeholders seeking to ensure consistent access to Plaquenil.

Manufacturers of Hydroxychloroquine (Plaquenil)

Hydroxychloroquine is synthesized through complex chemical processes requiring specialized facilities complying with stringent Good Manufacturing Practices (GMP). The main global suppliers include major pharmaceutical corporations, generic drug manufacturers, and contract manufacturing organizations (CMOs).

1. Sanofi

Sanofi, a global leader in the pharmaceutical industry, originally developed Plaquenil. Historically, Sanofi has maintained manufacturing facilities dedicated to hydroxychloroquine production, ensuring high-quality standards and regulatory compliance. Their global distribution network supports widespread availability, especially within North America and Europe.

2. Teva Pharmaceuticals

Teva, one of the largest generic drug manufacturers worldwide, supplies hydroxychloroquine across multiple markets. Teva's extensive manufacturing infrastructure in Israel, India, and the United States allows for scalable production to meet fluctuating demands. Their compliance with international regulatory standards, including FDA and EMA approvals, positions them as a critical supplier.

3. Mylan (Now part of Viatris)

Mylan, recently merged with Pfizer's Upjohn to form Viatris, has been a significant supplier of hydroxychloroquine. Their manufacturing sites in India and the United States produce large quantities for global distribution, including markets with high malaria incidence and autoimmune disease prevalence.

4. Sandoz (Novartis Division)

Sandoz, the generics division of Novartis, manufactures hydroxychloroquine in compliance with international GMP standards. Sandoz’s robust global network ensures widespread availability, particularly in developing countries where access to affordable medicine is crucial.

5. contracted and smaller manufacturers

In addition to these giants, various regional and contract manufacturing organizations produce hydroxychloroquine under licensing agreements. Several Indian pharmaceutical firms, including Lupin and Cadila Healthcare, have contributed significantly to global supplies, particularly during the COVID-19 pandemic.

Supply Chain Dynamics and Market Challenges

The supply chain for hydroxychloroquine has undergone significant stress during health crises. Factors influencing supplier stability include:

• Raw Material Availability: The synthesis of hydroxychloroquine relies on specific chemical precursors, often sourced from China and India. Disruptions in the supply of raw materials can impact production capacity.

• Regulatory Approvals and Export Controls: During COVID-19, certain countries implemented export restrictions, constraining global supply channels [1]. Future disruptions may occur due to regulatory changes or manufacturers' compliance issues.

• Manufacturing Capacity and Scalability: Rapidly increasing production during high-demand periods strains existing manufacturing infrastructure. Sanofi, Teva, and others expanded capacity during peak COVID-19 phases but maintaining these levels is economically challenging.

• Quality and Regulatory Compliance: Ensuring high standards is non-negotiable. Quality lapses can lead to recalls, impacting supply continuity.

Global Distribution and Market Access

Supply reliability for Plaquenil hinges on a network that spans North America, Europe, Asia, and Africa. In developed markets, several suppliers maintain stockpiles and distribution channels aligned with regulatory approvals. Conversely, in low-resource settings, the reliance on Indian and Chinese manufacturers is more pronounced. Key considerations include:

• Regulatory Approvals: Suppliers must secure and maintain registration with agencies like the FDA, EMA, and local health authorities to ensure legal sale and distribution.

• Pricing and Affordability: Generic manufacturers primarily determine competitive pricing, impacting accessibility in lower-income countries.

• Strategic Stockpiling: Governments and organizations like WHO maintain stockpiles, informing supplier stability and demand forecasts.

Emerging Trends and Future Outlook

The landscape of Plaquenil suppliers is evolving, driven by public health emergencies, patent considerations, and manufacturing innovations. Notable trends include:

• Expansion of Indian and Chinese manufacturing: These regions continue to amplify production capacity to meet global demand, bolstered by favorable regulations and cost advantages.

• Quality assurance improvements: International agencies emphasize strict GMP adherence, preventing substandard manufacturing.

• Potential for biosimilars and new formulations: Innovations aim to improve bioavailability and reduce side effects, potentially broadening supplier bases and market competition.

Conclusion

The supply chain for Plaquenil remains robust, primarily driven by major pharmaceutical companies like Sanofi, Teva, and Viatris, along with significant contributions from Indian generics producers. While production capacity remains high, vulnerabilities tied to raw material sourcing, regulatory environments, and global health crises require continuous monitoring. Ensuring supplier diversity and resilient supply chains is essential for healthcare providers and policymakers seeking to maintain uninterrupted access to this critical medication.

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Key Takeaways

• Major Suppliers: Sanofi, Teva, Viatris (formerly Mylan), and Sandoz dominate the hydroxychloroquine market, supported by regional producers including Indian firms.

• Supply Risks: Raw material sourcing, export restrictions, and demand surges pose ongoing risks; diversification and strategic stockpiling mitigate shortages.

• Regulatory Compliance: Maintaining GMP standards and regulatory approvals is critical for supplier credibility and supply security.

• Market Trends: Increased manufacturing capacity in India and China, coupled with quality improvements, will likely sustain supply in the medium term.

• Strategic Implication: Stakeholders should develop diversified supplier portfolios and monitor raw material markets to ensure consistent access.

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FAQs

1. Who are the leading global suppliers of hydroxychloroquine?
   Leading suppliers include Sanofi, Teva Pharmaceuticals, Viatris (formerly Mylan), and Sandoz, supported by regional manufacturers in India and China.

2. What challenges affect the global supply of Plaquenil?
   Challenges include raw material shortages, export restrictions, capacity limitations, and quality compliance issues.

3. How has the COVID-19 pandemic impacted Plaquenil supply?
   The pandemic caused unprecedented demand spikes and export restrictions, leading to shortages and prompting capacity expansions in key manufacturing regions.

4. Are there regional differences in Plaquenil availability?
   Yes, North America and Europe benefit from multiple well-established suppliers, whereas low-resource regions rely heavily on Indian and Chinese manufacturers.

5. What should healthcare providers consider regarding Plaquenil supply security?
   Providers should establish relationships with multiple reliable suppliers, monitor supply chain disruptions, and maintain appropriate stock levels to prevent shortages.

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Sources:

[1] World Health Organization. "Impact of COVID-19 on the supply of essential medicines." 2021.