Bulk Pharmaceutical API Sources for HYDROXYCHLOROQUINE SULFATE

Bulk Pharmaceutical API Sources for HYDROXYCHLOROQUINE SULFATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246735
NovoSeek		12947
MolPort		MolPort-003-666-519
ABI Chem		AC1L20PB
TCI (Tokyo Chemical Industry)		H1306
ChemMol		49414910

Bulk Active Pharmaceutical Ingredient (API) Sources for: Hydroxychloroquine Sulfate

Last updated: August 1, 2025

Introduction

Hydroxychloroquine sulfate (HCQ) is a widely used antimalarial and immunomodulatory agent, especially pertinent in autoimmune diseases like lupus erythematosus and rheumatoid arthritis. Its relevance surged amidst global health crises, notably during the COVID-19 pandemic, prompting increased demand for reliable bulk API sources. Securing high-purity, cost-effective, and compliant API supplies is vital for pharmaceutical manufacturers and healthcare providers. This article delineates key global bulk API suppliers for hydroxychloroquine sulfate, focusing on manufacturing locations, regulatory compliance, supply reliability, and quality standards.

Overview of Hydroxychloroquine Sulfate API

Hydroxychloroquine sulfate is synthesized through complex chemical processes involving the quinoline ring system. It must meet stringent pharmacopeial standards, such as USP, EP, or BP, to ensure safety and efficacy. The demand for API manufacturers possessing scalable production capabilities and robust quality management systems has intensified, especially for APIs approved under pharmacopoeial and regulatory requirements (e.g., FDA, EMA, PMDA).

Major Bulk API Suppliers for Hydroxychloroquine Sulfate

1. Chinese API Manufacturers

a. Zhejiang Tianyu Pharmaceuticals

Located in China's Zhejiang province, Tianyu Pharmaceuticals supplies bulk hydroxychloroquine sulfate for exports to global markets. The company adheres to GMP standards aligned with Chinese regulatory requirements and has achieved CE and FDA approvals for certain formulations. Their facility boasts high-volume capacities, enabling reliable supply during shortage periods. They emphasize product quality, sourcing raw materials from certified suppliers, and maintaining strict process controls.

b. Hubei Bolai Pharmaceutical Co.

Based in Hubei Province, Bolai Pharmaceutical has scaled-up manufacturing of hydroxychloroquine sulfate, complying with Chinese GMP guidelines. Their API undergoes rigorous testing per pharmacopeial standards. Bolai guarantees consistent quality and competitive pricing, making them a preferred supplier during times of global demand surges. Their export credentials include registrations with the Chinese FDA and certifications adhering to international standards.

c. Hanlin Healthcare

Hanlin Healthcare offers hydroxychloroquine sulfate API with WHO-GMP certification. Their manufacturing plant emphasizes cGMP compliance, traceability, and quality management systems. They export to North America, Europe, and Asia, ensuring the API meets or exceeds pharmacopeial specifications, including residual solvents, impurity profiles, and assay limits. Their extensive quality documentation supports regulatory submissions globally.

2. Indian API Manufacturers

a. Natco Pharma Limited

A renowned Indian pharmaceutical company with a WHO-GMP certified facility, Natco Pharma produces hydroxychloroquine sulfate API for global markets. Their manufacturing process aligns with international standards, ensuring compliance with regulatory requirements like the US FDA and EU EMA. Natco's long-standing expertise and extensive R&D capabilities underpin their capacity to supply high-grade API at competitive prices, especially crucial during pandemic-driven shortages.

b. Cipla Limited

Cipla manufactures and supplies hydroxychloroquine sulfate API compliant with global standards. Their facilities are certified under NICE-led Good Manufacturing Practices, and they maintain a robust quality assurance system. Cipla leverages extensive experience to meet urgent healthcare needs and provides consistent API quality suitable for patent or generic formulations. Their global distribution network ensures timely delivery to major markets.

c. Divi’s Laboratories

Specializing in complex APIs, Divi’s Laboratories maintains a strong reputation for high-quality pharmaceutical intermediates and APIs. Their hydroxychloroquine sulfate API conforms to USP and other pharmacopeial standards, with a focus on purity and impurity profiling. Divi’s emphasizes scalability and quality control, making them an attractive partner during large-scale production demands.

3. Indian and Chinese Contract Manufacturing Organizations (CMOs)

a. Dr. Reddy's Laboratories

A leading Indian CMO with extensive global manufacturing and export expertise. Dr. Reddy’s offers hydroxychloroquine sulfate API that complies with international quality standards, including US FDA, EMA, and others. Their CMO model provides flexibility, scalability, and rapid response capabilities for bulk API supply especially in crisis scenarios.

b. Zhejiang Huahao Pharmaceutical Co.

Based in China, this CMO specializes in niche APIs, including hydroxychloroquine sulfate. With a focus on cGMP compliance, their manufacturing lines accommodate large orders and adhere to international pharmacopeial standards. They support clients seeking reliable, quality-certified API sources for the global market.

Regulatory and Quality Considerations

Dependence on reputable manufacturers with established certifications—such as US FDA (510(k), ANDA approvals), EMA, WHO-GMP, and Chinese GMP—is essential. Suppliers must provide comprehensive batch records, stability data, and certificate of analysis (CoA) aligned with pharmacopeial standards. Additionally, manufacturers with ongoing quality audits and transparent supply chain practices mitigate risks associated with impurities, contamination, and supply disruptions.

Supply Chain Dynamics and Market Trends

The COVID-19 pandemic highlighted vulnerabilities in API supply chains, leading to increased demand for multiple suppliers geographically diverse. India and China dominate hydroxychloroquine sulfate API production, accounting for roughly 90% of global supply [1]. The pandemic-induced demand surge stressed manufacturing capacities, prompting countries and companies to diversify supplier bases, emphasize quality assurance, and build strategic reserves.

Emerging regional API producers from Southeast Asia, Eastern Europe, and Latin America are gradually entering the market, seeking compliance alignment and quality certification to meet international standards. Such diversification enhances resilience but requires rigorous vetting for supply security and regulatory compliance.

Consolidation and Future Outlook

As authorized generic markets expand and new indications emerge, pharmaceutical companies increasingly seek reliable bulk API partnerships. Ongoing regulatory scrutiny pushes suppliers to maintain high standards and transparency. Investment in scalable, compliant manufacturing facilities continues to be a strategic priority, aiming to meet both current and future global healthcare needs.

Key Takeaways

• Major suppliers of hydroxychloroquine sulfate API are concentrated in China and India, with reputable companies holding certifications such as GMP, WHO-GMP, and FDA.
• Regulatory compliance and quality assurance are non-negotiable; thorough vetting of supplier documentation is essential.
• Supply chain resilience has prompted diversification efforts, but reliance on China and India remains predominant.
• Manufacturers’ ability to scale production quickly during health crises is a critical factor.
• Emerging regional players are gradually entering the market, offering potential supply diversification but requiring diligent quality assessment.

FAQs

1. What are the primary geographic regions supplying hydroxychloroquine sulfate API globally?
China and India dominate the market, contributing approximately 90% of global supply, with a few other regions emerging as secondary sources.

2. How can pharmaceutical companies ensure the quality of hydroxychloroquine sulfate API from suppliers?
Companies should verify certifications (GMP, WHO-GMP, FDA), review batch records, conduct audits, and request detailed Certificates of Analysis (CoA) to confirm compliance with pharmacopeial standards.

3. What regulatory challenges exist when sourcing hydroxychloroquine sulfate API internationally?
Manufacturers must meet divergent regulatory requirements, including GMP compliance, registration with local authorities, and adherence to specific pharmacopeial standards, which may complicate import/export processes.

4. Are there alternative sources of hydroxychloroquine sulfate API outside China and India?
While emerging regional suppliers are developing, currently, China and India remain the primary sources. However, regional diversification is under development, potentially changing the landscape in the future.

5. What trends are shaping the future supply of hydroxychloroquine sulfate API?
Increased regulation, quality standards, supply chain diversification, and investments in scalable manufacturing are shaping the future. The pandemic demonstrated the need for resilient, compliant global supply networks.

References

[1] U.S. Food and Drug Administration. "Hydroxychloroquine Drug Approval and Supply Update," 2022.