Bulk Pharmaceutical API Sources for HETRAZAN

Bulk Pharmaceutical API Sources for HETRAZAN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		15432
Sigma-Aldrich		D8765_ALDRICH
MP Biomedicals		190192
TCI (Tokyo Chemical Industry)		D1898
MolPort		MolPort-003-665-489

Bulk Active Pharmaceutical Ingredient (API) Sources for Hetrazan

Last updated: July 29, 2025

Introduction

Hetrazan, known chemically as Diethylcarbamazine Citrate (DEC), is a pivotal antiparasitic medication predominantly used in the treatment of filarial infections, including lymphatic filariasis and tropical pulmonary eosinophilia. As a frontline therapeutic agent, the procurement of high-quality bulk APIs—specifically, Diethylcarbamazine Citrate—is foundational for pharmaceutical manufacturers aiming to produce effective, compliant, and affordable formulations. This article offers a comprehensive analysis of globally recognized API sources for Hetrazan, highlighting supply chain dynamics, quality standards, and strategic considerations relevant to industry stakeholders.

Understanding Diethylcarbamazine Citrate: The API of Hetrazan

Diethylcarbamazine Citrate (DEC) is synthesized through chemical processes that involve multi-step reactions and stringent purification to meet pharmacopeial standards. The API's purity, potency, and stability are guided by pharmacopoeias like the USP, BP, and EP, which set specifications for identity, purity, residual solvents, and microbiological safety.

Global API Manufacturers for Diethylcarbamazine Citrate

The API landscape for Hetrazan is characterized by a few established manufacturers with proven compliance to international quality standards. The landscape can be broadly categorized into pharmaceutical giants, reputable mid-tier suppliers, and emerging API producers.

1. Indian Manufacturers

India remains a dominant force in API manufacturing, leveraging cost-effective production, robust quality standards, and extensive export capabilities.

• Sun Pharma Laboratories Ltd.: A major player, Sun Pharma supplies DIethylcarbamazine Citrate conforming to WHO prequalification and other global standards. Their API facilities are certified under GMP, providing reliable supply chains.

• Micro Labs Ltd.: Micro Labs manufactures DEC API for domestic and export markets, adhering to pharmacopoeial standards. Their integrated manufacturing process ensures quality and consistency.

• Lupin Limited: Lupin produces a range of APIs, including DEC, with facilities compliant with global regulatory bodies. Their focus on quality control and R&D accelerates supply reliability.

• Aurobindo Pharma: An established API manufacturer with WHO-GMP and USFDA approval, providing globally acceptable DEC APIs that meet strict regulatory demands.

2. Chinese API Manufacturing

China's API sector has grown significantly, driven by cost advantages and expanding capacity.

• Shandong Xinhua Pharmaceutical Co., Ltd.: Recognized for APIs including DEC, with certifications aligned with international standards.

• Qingdao Haiwan Pharmaceutical Co., Ltd.: Their product portfolio includes Diethylcarbamazine Citrate, with GMP certification and export licenses.

• Zhejiang Pharma Co. Ltd.: Offers DEC APIs certified under international quality norms, serving emerging markets and supplementing supply chains.

3. European and North American Suppliers

While less prominent due to higher costs, certain European and North American companies offer niche, high-purity APIs.

• BASF (Germany): A global chemical leader, BASF supplies high-quality APIs, including DEC, with an emphasis on stringent manufacturing standards.

• Cambridge Commodities (UK): Specializes in fine chemicals and APIs with GMP certification, serving research and regulatory markets.

4. Emerging and Other Sources

Emerging markets and smaller suppliers are increasingly capable of providing DEC APIs that meet regulatory standards, often at competitive prices, though due diligence on quality certification is advisable.

Supply Chain Considerations

Securing reliable API sources for Hetrazan requires thorough evaluation of several factors:

• Regulatory Compliance: Suppliers must hold certifications such as WHO-GMP, USFDA, EMA, or equivalents to ensure quality and facilitate global registration.

• Quality Assurance and Certification: Certificates of Analysis (CoA), stability data, and batch consistency are critical. Verification through audits and supplier audits mitigates risks.

• Supply Stability: Long-term supply agreements with multiple suppliers reduce procurement risks, especially in the face of geopolitical or manufacturing disruptions.

• Cost and Lead Times: Competitive pricing must be balanced with quality assurances; supply chain agility is vital for meeting market demands.

• Geopolitical and Trade Policies: Export restrictions, tariffs, and international sanctions influence sourcing decisions.

Quality Standards & Regulatory Compliance

Suppliers must demonstrate adherence to pharmacopoeial standards, validated manufacturing processes, and consistent batch quality. For markets relying on WHO prequalification or stringent regulatory authority (SRA) approval, sourcing APIs from certified manufacturers is essential for seamless registration and market entry.

Emerging Trends and Strategic Sourcing

• Bioequivalent or Alternative APIs: While DEC remains the primary API for Hetrazan, research into alternative compounds or formulations may influence future sourcing patterns.

• Supply Chain Diversification: Diversification across geographic regions minimizes risks associated with regional upheavals, supplier monopolies, or quality lapses.

• Integration and Vertical Supply Chains: Some pharmaceutical firms vertically integrate API manufacturing to ensure quality and supply security, impacting market dynamics.

Conclusion

Selecting a reliable source for DIethylcarbamazine Citrate is central to the sustainable production of Hetrazan. Indian manufacturers lead due to their capacity and cost advantages, with Chinese and European suppliers supplementing the market. Ensuring compliance with international quality standards remains paramount, with regulatory certifications serving as key benchmarks. Strategic partnership, ongoing quality audits, and diversification are prudent approaches to secure a resilient supply chain.

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Key Takeaways

• Indian API manufacturers dominate the DEC market, supported by extensive GMP-certified facilities.

• Regulatory compliance (WHO-GMP, USFDA, EMA) is essential for global market acceptance and quality assurance.

• Diversification of API sources reduces supply chain vulnerabilities and ensures consistent availability.

• Higher-grade APIs from European suppliers are suitable for high-end markets but involve higher costs.

• Continuous monitoring of supplier quality, regulatory updates, and geopolitical factors is vital for effective procurement.

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FAQs

1. What are the primary countries producing APIs for Hetrazan?
India, China, and select European countries are the main sources, with India being the dominant supplier due to capacity and cost competitiveness.

2. How important is regulatory certification when sourcing DEC APIs?
Extremely critical. Certifications like WHO-GMP or USFDA approval demonstrate compliance with quality standards, facilitating market access and regulatory approval.

3. Can I source DEC APIs from emerging suppliers?
Yes, but due diligence is necessary. Verify certifications, conduct supplier audits, and review certification documentation to ensure quality.

4. What factors influence the cost of DEC APIs?
Manufacturing scale, regulatory compliance, quality standards, geographic location, and supply chain logistics all impact pricing.

5. Are there alternatives to DIethylcarbamazine Citrate for filarial infections?
While DEC remains the standard, research into alternative therapies exists but is not yet widely adopted. The API sourcing focus remains on DEC due to established efficacy.

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References

[1] World Health Organization. (2021). Guidelines for the quality assurance of medicines.
[2] U.S. Pharmacopeia. (2022). USP Diethylcarbamazine Citrate Monograph.
[3] European Pharmacopoeia. (2021). Diethylcarbamazine Citrate Monograph.
[4] Indian Pharmacopoeia Commission. (2022). API manufacturing standards in India.
[5] Industry reports on global API manufacturing capacity, 2022.