HYDROXYCHLOROQUINE SULFATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342	ANDA	Accord Healthcare, Inc.,	16729-485-01	100 TABLET in 1 BOTTLE (16729-485-01)	2020-05-12
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342	ANDA	Accord Healthcare, Inc.,	16729-485-16	500 TABLET in 1 BOTTLE (16729-485-16)	2020-05-12
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342	ANDA	Accord Healthcare, Inc.,	16729-561-01	100 TABLET in 1 BOTTLE (16729-561-01)	2021-09-28
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342	ANDA	Accord Healthcare, Inc.,	16729-562-01	100 TABLET in 1 BOTTLE (16729-562-01)	2021-09-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Hydroxychloroquine sulfate (HCQ) has garnered global attention as a widely used antimalarial and immunomodulatory drug. Its application has expanded due to its potential efficacy in treating autoimmune diseases such as lupus erythematosus and rheumatoid arthritis, and its controversial exploration as a COVID-19 therapy. As demand fluctuates, especially during health crises, a comprehensive understanding of key suppliers for hydroxychloroquine sulfate becomes essential for pharmaceutical companies, healthcare providers, and policymakers.

This article analyzes the global landscape of suppliers for hydroxychloroquine sulfate, including major manufacturers, regional producers, and the implications for supply chain security. It provides a detailed overview, market insights, and strategic considerations for stakeholders in the pharmaceutical supply chain.

Market Overview of Hydroxychloroquine Sulfate

Hydroxychloroquine sulfate is a synthetic derivative of chloroquine, with modifications that reduce toxicity and improve pharmacokinetics. The drug's synthesis involves complex chemical processes, requiring high-quality raw materials and stringent manufacturing standards, as set forth by regulatory agencies such as the FDA and EMA.

The market for hydroxychloroquine surged during the early stages of the COVID-19 pandemic, leading to supply shortages and increased scrutiny of manufacturing and distribution channels. While the global demand has fluctuated, continuous supply remains critical for treating autoimmune conditions and potential pandemic responses.

Major Manufacturers and Regional Suppliers

1. Indian Pharmaceutical Companies

India’s pharmaceutical sector dominates the global production of hydroxychloroquine sulfate, accounting for a significant portion of the worldwide supply.

Ipca Laboratories Ltd.
As one of India's largest API manufacturers, Ipca has robust production facilities capable of producing hydroxychloroquine sulfate at scale. The company is USFDA- and EDQM-approved, ensuring adherence to international quality standards.
Cipla Limited
Cipla is a key player in both API synthesis and finished dosage formulations of HCQ. Their manufacturing processes are GMP-compliant, supplying various markets globally.
Bharat Serums and Vaccines Limited
With established API manufacturing capabilities, Bharat Serums has been a reliable supplier, especially during periods of heightened demand.
Torrent Pharmaceuticals
Torrent produces hydroxychloroquine sulfate API primarily for export, with a focus on quality and compliance.

Note: Indian firms benefit from Government support and a well-developed API manufacturing ecosystem, making India a primary source of hydroxychloroquine sulfate globally.

2. Chinese Manufacturers

China’s pharmaceutical industry also contributes significantly to the hydroxychloroquine sulfate supply chain.

Shanghai Huaxin Pharmaceutical Co., Ltd.
Known for producing APIs with high efficiency, Huaxin supplies to global markets, including North America and Europe.
Zhejiang Hailong Pharmaceutical Co., Ltd.
Offers hydroxychloroquine sulfate API compliant with international standards.
Hubei Yiling Pharmaceutical Co., Ltd.
A major supplier with a reputation for reliable API production, primarily serving Asian markets but expanding globally.

Chinese producers benefit from significant manufacturing capacity, competitive pricing, and government support, although regulatory approvals vary across jurisdictions.

3. European and North American Suppliers

Manufacturers in Europe and North America are comparatively fewer but focus on high-quality API and finished formulations.

Novartis
Historically involved in hydroxychloroquine development, Novartis supplies both the drug and related APIs in some regions, adhering to stringent regulatory standards.
Lupin Limited (India-based, global operations)
Lupin’s operations extend globally, providing high-quality APIs with GMP certification.

4. Emerging and Contract Manufacturers

Numerous smaller and contract manufacturing organizations (CMOs) are increasingly involved in hydroxychloroquine sulfate production, often producing under contract for larger pharmaceutical firms.

Recipharm
A Swedish CMO with capacity to produce HCQ API, complying with GMP standards.
Daiichi Sankyo and other Japanese CMOs
Supporting the supply chain with specialized manufacturing capabilities.

Supply Chain and Quality Considerations

Supply chain reliability for hydroxychloroquine sulfate hinges on manufacturing capacity, regulatory compliance, and geopolitical factors. The drug’s global reputation for safety and efficacy requires suppliers to meet rigorous quality standards, including Good Manufacturing Practice (GMP) certification.

Regulatory approvals significantly influence supplier credibility. The FDA, EMA, and other agencies routinely audit manufacturing facilities, impacting the ease of distribution and market access.

Raw Material Sourcing: Quality and availability of precursor chemicals, such as 4,7-dichloroquinoline and related intermediates, impact production. Major suppliers typically operate integrated supply chains to mitigate disruptions.

Patent and Regulatory Status: Since hydroxychloroquine sulfate is off-patent globally, generic manufacturers dominate the market, increasing supply diversity but intensifying quality and compliance challenges.

Geopolitical and Market Dynamics

The surge in demand during the COVID-19 pandemic strained global supplies, exposing vulnerabilities in supply chains heavily dependent on specific regions, notably India and China. Trade restrictions and export bans during health crises highlighted the need for diversified sourcing strategies.

The geopolitical landscape influences supplier availability. For instance, India temporarily restricted hydroxychloroquine exports at the pandemic’s onset to prioritize domestic needs, prompting a reevaluation of supply diversification pathways.

Efforts to establish regional manufacturing hubs, enhance raw material production, and build strategic stockpiles are underway to mitigate such vulnerabilities.

Regulatory and Compliance Challenges

Suppliers must meet stringent regulatory requirements to ensure drug safety and efficacy. Differences in quality standards and approval processes across regions necessitate that companies carefully evaluate supplier credentials, inspection histories, and batch consistency records.

GMP certification, Good Laboratory Practice (GLP), and compliance with ICH guidelines are non-negotiable benchmarks for credible suppliers.

Strategic Implications for Stakeholders

Procurers and distributors should prioritize:

Supplier diversification to mitigate geopolitical and supply disruptions.
Establishing quality assurance protocols aligned with international standards.
Monitoring regulatory updates that could impact manufacturing and export licenses.
Securing long-term contracts with reliable manufacturers to ensure supply continuity.
Investing in regional manufacturing capacity to reduce dependence on specific countries.

Key Takeaways

India and China dominate global hydroxychloroquine sulfate manufacturing, leveraging large-scale API production capacities and competitive pricing.
European and North American suppliers focus on high-quality APIs, often catering to regulated markets with strict compliance requirements.
Supply chain vulnerabilities during the COVID-19 pandemic underscored the importance of diversification, strategic stockpiling, and regional manufacturing investments.
Regulatory compliance, including GMP certification and adherence to international standards, remains a critical determinant of supplier credibility.
Stakeholders should develop risk mitigation strategies, including building diversified supplier networks and investing in capacity expansion.

FAQs

1. Who are the leading global suppliers of hydroxychloroquine sulfate?
Indian pharmaceutical companies like Ipca Laboratories, Cipla, and Bharat Serums, alongside Chinese producers such as Shanghai Huaxin Pharmaceutical and Zhejiang Hailong Pharmaceutical, are the primary global suppliers.

2. What quality standards must hydroxychloroquine sulfate suppliers meet?
Suppliers must adhere to Good Manufacturing Practice (GMP), comply with FDA, EMA, and other regional regulatory standards, and ensure batch-to-batch consistency.

3. How has the COVID-19 pandemic affected hydroxychloroquine supply chains?
The pandemic caused significant disruptions due to export restrictions, increased demand, and supply shortages, prompting calls for diversification and domestic manufacturing expansions.

4. Are there regional restrictions on hydroxychloroquine sulfate manufacturing or export?
Yes. For example, India temporarily restricted exports during the pandemic’s early phase, highlighting geopolitical influence on supply availability.

5. What strategies should companies adopt to secure hydroxychloroquine sulfate supplies?
Diversify supplier bases, establish long-term contracts, ensure rigorous quality verification, and consider regional manufacturing investments to mitigate risks.

References

[1] Indian Pharmacopoeia Commission. Guidelines for API manufacturing. 2021.
[2] U.S. Food and Drug Administration. API Approval and Quality Standards. 2022.
[3] International Council for Harmonisation. Quality Guidelines. 2021.
[4] MarketWatch. Hydroxychloroquine Sulfate Market Analysis and Forecast. 2023.
[5] European Medicines Agency. Manufacturing Standards for APIs. 2022.

Suppliers and packagers for generic pharmaceutical drug: HYDROXYCHLOROQUINE SULFATE