Bulk Pharmaceutical API Sources for ATOVAQUONE

Bulk Pharmaceutical API Sources for ATOVAQUONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-542
Vitas-M Laboratory		STK636160
AKos Consulting & Solutions		AKOS005567953
AKos Consulting & Solutions		AKOS015895691
AKos Consulting & Solutions		AKOS015961933
CAPOT		20255

Bulk Active Pharmaceutical Ingredient (API) Sources for Atovaquone

Last updated: July 28, 2025

Introduction

Atovaquone is a medication primarily used to treat and prevent Pneumocystis pneumonia, toxoplasmosis, and certain malaria forms. It functions by selectively inhibiting mitochondrial electron transport in protozoa and fungi, disrupting their energy production. As a vital API, sourcing high-quality Atovaquone is critical for pharmaceutical manufacturers, impacting drug efficacy, safety, and regulatory compliance. This analysis provides a comprehensive overview of prominent bulk Atovaquone API suppliers, highlighting their manufacturing capabilities, geographic distribution, quality standards, and market positioning.

Global API Landscape for Atovaquone

The procurement of Atovaquone begins with understanding the global API manufacturing ecosystem. Several key players operate across different continents, primarily in Asia, North America, and Europe, supplying pharmaceutical companies with bulk API products. Factors influencing supplier selection include manufacturing accreditation, supply consistency, regulatory compliance, pricing, and logistics.

Major API Manufacturers and Suppliers

1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Zhejiang Hisun is a leading Chinese API manufacturer with extensive experience in antimicrobial and antiparasitic APIs. The company produces Atovaquone within a comprehensive GMP-certified environment, adhering to international standards such as FDA, EMA, and WHO. Their facilities leverage advanced synthesis processes to ensure high purity API batches, catering to both domestic and export markets.

• Strengths: Competitive pricing, large manufacturing capacity, robust quality management systems.
• Certifications: GMP, ISO 9001, and ISO 14001.
• Market Focus: Asia, North America, Europe.

2. Mylan N.V. (now part of Viatris) (USA)

Viatris maintains a significant API manufacturing footprint through its longstanding facilities in the U.S. and India. Their products meet stringent regulatory standards, ensuring high purity and batch consistency. Mylan's Atovaquone API benefits from the company's extensive quality control, supply chain strength, and global distribution network.

• Strengths: Proven regulatory track record, compliance with cGMP, high Quality Assurance standards.
• Certifications: FDA-approved facilities, ISO certifications.
• Market Focus: North America, Europe, Asia.

3. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Another Chinese industry player, Hisun, offers a reliable supply of Atovaquone API, with production facilities certified according to international standards. Their capacity to deliver large volume orders and maintain quality consistency makes them a preferred supplier for global pharmaceutical firms.

• Strengths: Cost competitiveness, broad product portfolio, extensive R&D.
• Certifications: GMP, ISO 9001, and others.
• Market Focus: Asia, Latin America, Africa.

4. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Huahai has established a reputation for producing a wide range of APIs, including antiparasitic agents. Their Atovaquone manufacturing process emphasizes high purity and low impurity profiles, adhering to global regulatory standards.

• Strengths: Advanced synthetic methodologies, scalable manufacturing.
• Certifications: GMP, ISO 9001, and other international standards.
• Market Focus: Asia, Europe, North America.

5. Sun Pharmaceutical Industries Ltd. (India)

As a major Indian API manufacturer, Sun Pharma supplies Atovaquone to several global markets. Their API manufacturing facilities are certified by the US FDA, European EMA, and other regulatory agencies, ensuring quality and compliance.

• Strengths: Established supply chain, competitive pricing, regulatory compliance.
• Certifications: cGMP, ISO standards.
• Market Focus: North America, Europe, Asia.

6. Other Notable Suppliers

• Lek Pharmaceuticals (Slovenia): Offers high-purity APIs with a history of regulatory compliance.
• Zhejiang Tianyu Pharmaceutical Co., Ltd. (China): Growing presence in API manufacturing.
• Dongying Tiandatu Pharmaceutical Co., Ltd. (China): Emerging API supplier focusing on antiparasitic agents.

Manufacturing and Quality Considerations

Manufacturing Processes

Atovaquone synthesis involves complex chemical pathways requiring stringent control of reaction conditions to ensure API purity. The main synthesis routes include:

• Hydrogenation and halogenation steps
• Purification via crystallization and chromatography
• Stringent impurity profiling

Suppliers with robust manufacturing process control and modern facilities tend to produce APIs with consistent batch-to-batch purity, meeting pharmacopeial standards such as USP, EP, or JP.

Quality Assurance and Regulatory Compliance

High-quality API suppliers maintain rigorous quality control systems, including:

• Analytical testing: HPLC, GC, NMR, IR, and mass spectrometry to verify purity, potency, and impurity profiles.
• Stability studies: Confirming API stability over time under various conditions.
• Regulatory adherence: Compliance with cGMP, ISO standards, and relevant regional authorities (FDA, EMA, PMDA).

Manufacturers with approved DMFs (Drug Master Files) provide added reassurance regarding API transparency and regulatory readiness.

Emerging Trends and Future Outlook

The global API supply chain for Atovaquone is evolving, driven by increased demand for antiparasitic therapeutics and the emphasis on supply chain resilience.

• Shift toward regional manufacturing: To reduce reliance on Chinese suppliers, several pharmaceutical companies are diversifying their supplier base to include Indian, European, and American manufacturers.

• Quality enhancement initiatives: Suppliers are investing in advanced synthetic methodologies to improve purity, reduce impurities, and meet evolving regulatory standards.

• Supply chain security: COVID-19 highlighted vulnerabilities, prompting companies to establish multi-source strategies, maintain safety stock, and validate alternate suppliers.

• Sustainability considerations: Focus on greener chemical processes and environmentally compliant manufacturing practices are gaining importance.

Regulatory and Logistical Considerations

Procurement of Atovaquone API necessitates a thorough review of supplier accreditations and compliance records. Importers should verify:

• GMP certification validity
• Compliance with regional regulatory requirements
• Supply continuity guarantees
• Quality control documentation (certificates of analysis, stability data)

Efficient logistics planning is essential to manage shipping timelines, especially for temperature-sensitive APIs, ensuring product integrity upon arrival.

Conclusion

Securing high-quality bulk Atovaquone API requires diligent evaluation of global suppliers based on manufacturing capabilities, regulatory compliance, cost efficiency, and supply reliability. Leading manufacturers in China (Zhejiang Hisun, Huahai), India (Sun Pharma), and the USA (Viatris) stand out for their capacity to deliver compliant, high-purity API batches. As supply chains evolve, diversification and quality assurance remain critical for pharmaceutical companies to meet patient needs effectively while maintaining regulatory standards.

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Key Takeaways

• Top Atovaquone API suppliers include Zhejiang Hisun (China), Viatris (USA), Sun Pharma (India), and Zhejiang Huahai (China).
• Manufacturing standards such as cGMP, ISO certifications, and regulatory approvals are vital indicators of supplier reliability.
• Suppliers are investing in advanced synthetic processes to improve purity, reduce impurities, and meet regulatory expectations.
• Diversification across geographic regions enhances supply chain resilience amid global disruptions.
• Due diligence in quality documentation, certification verification, and logistical planning is essential for pharmaceutical procurement.

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FAQs

1. What are the primary factors to consider when sourcing Atovaquone API?
Quality standards (GMP compliance), purity and impurity profiles, regulatory approvals, manufacturing capacity, delivery reliability, and pricing are critical.

2. Which regions are dominant in Atovaquone API manufacturing?
China and India are the primary manufacturing hubs due to their extensive API production infrastructure, with notable suppliers also in Europe and North America.

3. How important are regulatory certifications in API sourcing?
Extremely; certifications such as GMP approval, ISO standards, and regional regulator validations confirm manufacturing quality and compliance, vital for regulatory approval of final drug products.

4. Are there sustainable or eco-friendly practices among API suppliers?
Increasingly, suppliers are adopting greener synthesis methods, reducing waste, and complying with environmental regulations to enhance sustainability.

5. How can companies mitigate supply chain disruptions for Atovaquone API?
By establishing relationships with multiple suppliers across different regions, maintaining safety stock, performing rigorous supplier audits, and validating alternative sources proactively.

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Sources

[1] WHO Expert Committee on Specifications for Pharmaceutical Preparations, "Guidelines on Good Manufacturing Practices," 2019.
[2] U.S. Food and Drug Administration (FDA), "API Manufacturing Facility Approval," 2022.
[3] Zhejiang Hisun Pharmaceutical Co., Ltd. Official Website, Product Catalog.
[4] Viatris Corporate Reports, “Global API Production Capabilities,” 2022.
[5] Sun Pharmaceutical Industries Ltd., API Manufacturing Data Sheet, 2022.