Bulk Pharmaceutical API Sources for DIETHYLCARBAMAZINE CITRATE

Bulk Pharmaceutical API Sources for DIETHYLCARBAMAZINE CITRATE

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
ABI Chem		AC1L25VU
AKos Consulting & Solutions		AKOS003390253

Bulk Active Pharmaceutical Ingredient (API) Sources for Diethylcarbamazine Citrate

Last updated: August 9, 2025

Introduction

Diethylcarbamazine citrate (DEC) is a prominent antiparasitic agent primarily used in the treatment of filariasis, including lymphatic filariasis and tropical pulmonary eosinophilia. As an essential medicine, the quality, supply, and sourcing of DEC API are critical to global health strategies and pharmaceutical manufacturing. This article provides a comprehensive overview of the sources of bulk DEC citrate API, analyzing the key manufacturers, geographical considerations, regulatory landscape, and implications for healthcare providers and pharmaceutical companies.

Overview of Diethylcarbamazine Citrate (DEC)

DEC is a methylated pyrimidine derivative with the chemical name 2-(1-methyl-2-phenylethyl)-5-ethyl-1,3,4-thiadiazol-2-amine citrate. It acts by immobilizing microfilariae and altering their surface structure, facilitating immune clearance. The API's synthesis involves multi-step chemical processes, ensuring high purity for pharmaceutical applications.

Global Manufacturing Landscape

Leading API Producers

The global API industry for DEC citrate is predominantly concentrated in regions with robust pharmaceutical manufacturing sectors. Major API manufacturers include:

• India
• China
• United States (less common for APIs, but notable for certain high-quality suppliers)
• Europe (less prominent but notable for specialty or high-grade APIs)

Indian API Manufacturers

India remains a pivotal player in DEC citrate API sourcing, credited with producing the majority of the global supply. Prominent companies include:

• Macleods Pharmaceuticals: Known for its extensive API manufacturing portfolio, Macleods supplies bulk DEC citrate compliant with international standards.

• Aurobindo Pharma: A major B2B API supplier to global pharmaceutical companies, Aurobindo's DEC citrate API meets WHO GMP standards.

• Hetero Labs: Recognized for diverse APIs, Hetero provides DEC citrate with market approvals across various regions.

Chinese API Manufacturers

China's API industry has grown substantially, with numerous generic API producers offering DEC citrate. Key companies include:

• Hengkang Pharmaceutical: Offers bulk DEC citrate APIs, often at competitive prices.

• North China Pharmaceutical Group Corporation (NCPC): A state-owned enterprise producing a range of APIs, including DEC citrate.

• Shandong Xinhua Pharmaceutical: Supplies low-cost DEC citrate API to international markets.

Regulatory and Quality Considerations

Buyers should consider compliance with GMP standards and regulatory approvals such as the FDA, EMA, or WHO prequalification. Quality certifications and batch-to-batch consistency are vital for integration into high-quality pharmaceuticals.

Sources and Supply Chain Dynamics

Domestic Suppliers

Within India and China, domestic manufacturers frequently supply APIs to local pharmaceutical firms and export markets. Domestic sourcing reduces logistical complexities but requires rigorous quality verification.

Export-Oriented Manufacturers

Manufacturers exporting DEC citrate API often focus on regions with high demand, including Africa, Southeast Asia, and Latin America. These suppliers typically hold international GMP certifications to meet strict regulatory demands.

Imports and Contract Manufacturing

Pharmaceutical companies in developed markets often source DEC citrate via contract manufacturing organizations (CMOs) or global API brokers, ensuring adherence to quality standards and reliable supply chains.

Regulatory Landscape and Certification

The regulatory status of DEC citrate API varies by country:

• WHO Prequalification: Few manufacturers globally possess WHO prequalified APIs for DEC citrate, ensuring acceptance in procurement programs for neglected tropical diseases.

• GMP Certification: Most reputable suppliers possess cGMP certifications; however, buyers should verify recent audit reports and compliance.

• Pharmacopoeia Standards: API manufacturers often meet standards specified in pharmacopeias like USP, EP, or BP, influencing acceptance in different jurisdictions.

Supply Chain Challenges

• Pricing Fluctuations: Driven by raw material costs, manufacturing capacity, and regional economic factors.

• Quality Variability: Among low-cost Chinese suppliers, variability may impact efficacy and safety, necessitating rigorous testing.

• Supply Disruptions: API shortages or export restrictions can impact procurement, especially during geopolitical tensions or pandemics.

• Environmental and Ethical Considerations: Increasing scrutiny on sustainable manufacturing practices influences vendor selection.

Market Trends and Future Outlook

Increasing Demand for DEC API

Global health initiatives targeting lymphatic filariasis elimination are expanding the demand for DEC API. The WHO's advocacy for mass drug administration (MDA) programs amplifies the need for reliable API supply.

Advancement in Manufacturing Technologies

Innovations such as continuous manufacturing and green synthesis are expected to enhance yield, reduce costs, and improve environmental sustainability of DEC citrate API production.

Regulatory Harmonization

Enhanced global regulatory harmonization may streamline approval processes and facilitate market access, encouraging more manufacturers to produce compliant DEC APIs.

Implications for Stakeholders

• Pharmaceutical Companies: Must perform thorough due diligence on suppliers' quality standards and regulatory compliance.

• Healthcare Providers: Require assurance of API quality to ensure patient safety and treatment efficacy.

• Governments and Funding Agencies: Should prioritize procurement from WHO prequalified suppliers to optimize public health outcomes.

Key Takeaways

• India and China dominate global DEC citrate API manufacturing, with a growing number of suppliers achieving international regulatory standards.
• Buyers should prioritize suppliers with recognized GMP certification and WHO prequalification to ensure quality and regulatory compliance.
• The geopolitical landscape, environmental standards, and technological innovations influence future supply chain resilience.
• The expanding global demand, driven by disease elimination programs, underscores the necessity for diversified, reliable API sources.
• Engaging with reputable brokers and conducting rigorous supplier audits mitigate risks associated with quality variability and supply disruptions.

FAQs

1. What are the major regions supplying DEC citrate API globally?
India and China are the primary regions producing DEC citrate API, with additional contributions from the United States and Europe primarily catering to high-quality, regulated markets.

2. How can I verify the quality of DEC citrate API from a supplier?
Assess supplier GMP certification, conduct validation testing upon receipt, review batch documentation, and verify compliance with pharmacopeial standards such as USP or EP.

3. Are there specific regulatory certifications to look for when sourcing DEC citrate API?
Yes. Prefer suppliers with WHO prequalification, WHO-GMP certification, and approvals from major regulatory agencies such as the FDA, EMA, or local health authorities.

4. What factors influence the pricing of DEC citrate API?
Raw material costs, manufacturing capacity, quality certifications, geopolitical factors, export tariffs, and demand fluctuations significantly impact pricing.

5. Is there a trend toward sustainable manufacturing practices for DEC API?
Yes. Increasing emphasis on environmentally sustainable processes and ethical sourcing influences supplier selection, fostering innovation in green synthesis methodologies.

Conclusion

The sourcing of bulk diethylcarbamazine citrate API is dominated by manufacturers in India and China, supported by a growing emphasis on regulatory compliance and quality assurance. As global efforts intensify to eliminate filariasis, ensuring a resilient, quality-driven API supply chain becomes paramount. Stakeholders that perform diligent supplier assessments, prioritize compliance, and adapt to emerging manufacturing trends will secure reliable access to this critical antiparasitic API, ultimately advancing public health objectives worldwide.

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Sources:

[1] World Health Organization. (2020). "Guidelines for the Treatment of Lymphatic Filariasis."
[2] U.S. Pharmacopeia. (2022). USP General Chapter on API manufacturing standards.
[3] GlobalData. (2023). API Market Analysis and Outlook.
[4] Indian Pharmaceutical Alliance. (2021). "API Industry Overview."
[5] Chinese Pharmacopoeia Commission. (2022). Official Standards for APIs.