Bulk Pharmaceutical API Sources for OXAMNIQUINE

Bulk Pharmaceutical API Sources for OXAMNIQUINE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		4612
ABI Chem		AC1L1IK1
Chembase.cn		967
ChemTik		CTK8A2742
ChemMol		99049455
Aurora Fine Chemicals LLC		A17.944.355
BOC Sciences		21738-42-1

Bulk Active Pharmaceutical Ingredient (API) Sources for Oxamniquine

Last updated: July 29, 2025

Introduction

Oxamniquine, an anthelmintic agent primarily used in the treatment of Schistosoma mansoni infections, remains a vital component in parasitic disease control. While its clinical application is well-established, the procurement and sourcing of bulk Active Pharmaceutical Ingredient (API) are critical for manufacturers, researchers, and healthcare providers. This analysis delineates the global landscape of oxamniquine API suppliers, highlighting key manufacturing regions, regulatory considerations, and market dynamics to inform strategic sourcing decisions.

Overview of Oxamniquine API

Oxamniquine is a synthetic, aminosugar-based compound with an activity spectrum targeting Schistosoma species. Although not as widely produced as other anthelmintics like praziquantel, the API’s niche demand persists, especially for generic formulations in endemic regions. Its chemical structure and manufacturing complexity influence the supply chain landscape, impacting availability, cost, and regulatory compliance.

Global API Manufacturing Regions

1. India

India dominates the API manufacturing sector due to its extensive API synthesis expertise, cost efficiencies, and established regulatory framework. Several Indian pharmaceutical firms have developed capabilities for synthesizing oxamniquine, either as proprietary formulations or for export markets. Indian manufacturers benefit from a robust infrastructure supported by the Drug Price Control Order (DPCO) and Good Manufacturing Practice (GMP) standards aligned with WHO and international regulators.

2. China

China’s API industry has expanded rapidly, driven by cost advantages and large-scale manufacturing capacities. Chinese suppliers produce oxamniquine API, primarily serving markets in Asia and exporting to other continents. Most Chinese API manufacturers hold GMP certifications, and some are regulated by the National Medical Products Administration (NMPA). Due to supply chain globalization, Chinese APIs are often cost-competitive, though quality standards necessitate stringent due diligence.

3. Europe and the United States

While Europe and the U.S. have minimal direct production of oxamniquine API, certain APIs are sourced from European and North American API specialty firms, especially those adhering to strict regulatory standards. These regions tend to focus on high-quality, cGMP-compliant APIs, often for clinical or regulated markets, but their supply of oxamniquine is limited owing to market size and manufacturing complexity.

Major API Suppliers and Manufacturers

Company / Region	Capabilities	Certifications	Market Focus	Comments
Sun Pharmaceutical Industries Ltd. (India)	Production of various anthelmintic APIs	cGMP, WHO-GMP	Global, generic markets	Likely capable of producing oxamniquine upon demand
Hetero Labs Ltd. (India)	API synthesis, custom manufacturing	GMP	International	Potential supplier based on manufacturing scope
Zhejiang Huahai Pharmaceutical (China)	Large-scale API manufacture	GMP, ISO	Global	Known for high-volume, cost-effective APIs
North American Specialty Firms	Custom API manufacturing	cGMP, FDA-registered	Niche markets	Limited direct supply for oxamniquine but potential partners

Regulatory and Quality Considerations

API sourcing for oxamniquine necessitates rigorous compliance with regulatory standards. Indian and Chinese manufacturers predominantly hold WHO-GMP or equivalent certifications, ensuring product quality for global markets. For APIs destined for North American and European markets, suppliers must adhere to FDA or EMA GMP standards, including detailed batch records, stability profiles, and impurity profiles.

Suppliers should provide comprehensive documentation, including Certificate of Analysis (CoA), Certificates of Origin, and compliance certificates. Additionally, verification of patents, exclusivity rights, and whether oxamniquine APIs are subject to residual patent protections is essential, as patent statuses vary by jurisdiction and timeframe.

Market Dynamics and Supply Chain Challenges

The supply chain for oxamniquine API remains relatively niche due to the drug’s limited demand compared to other anthelmintics. Consequently, shortages are infrequent but can occur due to manufacturing scale limitations, geopolitical issues, or regulatory delays. The COVID-19 pandemic underscored supply chain vulnerabilities, emphasizing the need for diversified sourcing strategies.

Cost considerations dominate purchasing decisions in low- and middle-income countries, where Indian and Chinese manufacturers offer attractive pricing. However, procurement from these regions requires diligent quality assurance measures to ensure therapeutic efficacy and safety.

Emerging Trends and Future Outlook

• Manufacturing Consolidation: Larger API players are consolidating capacities, potentially reducing sourcing options but increasing consistency.
• Quality Standards: Increasing emphasis on cGMP compliance, especially for APIs intended for Europe and North America.
• Sustainability and Green Chemistry: Growing demand for environmentally friendly manufacturing processes influences suppliers’ operational practices.
• Regulatory Harmonization: Enhanced cooperation between agencies may streamline approval processes, impacting API availability.

Conclusion

Sourcing oxamniquine API necessitates strategic assessment of supplier qualification, manufacturing standards, cost, and regulatory compliance. Indian and Chinese API manufacturers lead in production capacity and market share, with top-tier certifications ensuring quality suitable for global distribution. As the demand for antiparasitic medications persists, diversifying suppliers and maintaining rigorous quality oversight will be pivotal. Future industry shifts may influence supply dynamics, but current data affirm a steady landscape for the procurement of high-quality oxamniquine API.

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Key Takeaways

• Indian and Chinese pharmaceutical companies are primary sources for oxamniquine API, offering cost-effective and reliable supply options.
• Regulatory compliance, including GMP certifications and documentation, is crucial when selecting API suppliers to meet international standards.
• Supply chain diversification reduces risks of shortages and ensures continuity for global health initiatives.
• Advancements in manufacturing technology and regulatory harmonization will likely improve API availability and quality assurance.
• Engaging with reputable, certified API manufacturers enables consistent supply for clinical, generic, and research applications.

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FAQs

1. Is oxamniquine API patent-protected, and can I manufacture it freely?
Oxamniquine’s patent status varies by jurisdiction and may have expired in many regions, enabling generic manufacturing. However, prospective producers should conduct thorough patent landscape analyses before initiating synthesis to avoid infringement issues[^1].

2. What factors should I consider when selecting an API supplier for oxamniquine?
Critical factors include certification status (GMP, WHO), manufacturing capacity, quality assurance protocols, price, lead times, regulatory compliance, and supplier reputation. Verification of batch consistency and impurity profiles is also essential.

3. Are there any regional restrictions on importing oxamniquine API?
Regulations differ globally; importation may require registration, certificates of analysis, or compliance with regional pharmaceutical standards. Regulatory authorities like the FDA, EMA, or local agencies govern importation processes.

4. What is the typical lead time for sourcing oxamniquine API?
Lead times generally range from 8 to 16 weeks, depending on supplier location, quantity, certification status, and regulatory clearance procedures.

5. How is quality assurance ensured for APIs sourced from China and India?
Through stringent validation processes, requesting detailed documentation, conducting audits, verifying certifications, and performing independent testing or third-party verification, buyers can ensure API quality standards are met.

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References

[1] World Intellectual Property Organization. (2022). Patent Landscape of Antiparasitic Drugs.