Bulk Pharmaceutical API Sources for niclosamide

Bulk Pharmaceutical API Sources for niclosamide

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		N3510_SIGMA
Hangzhou Trylead Chemical Technology		TL8003360
NovoSeek		4477
Vitas-M Laboratory		STK396676

Bulk Active Pharmaceutical Ingredient (API) Sources for NICLOSAMIDE

Last updated: July 29, 2025

Introduction

Niclosamide, a well-established anthelmintic agent primarily used for treating tapeworm infections, has garnered renewed interest owing to its potential antiviral, anticancer, and anti-inflammatory properties. As the pharmaceutical industry explores these new applications, ensuring a reliable and high-quality supply of Niclosamide API becomes critical. This comprehensive review examines current global sources for Niclosamide bulk API, highlighting manufacturing regions, key suppliers, regulatory considerations, and procurement strategies essential for pharmaceutical entities.

Manufacturing Landscape and Key API Suppliers

The international API market for Niclosamide is characterized by a handful of major pharmaceutical intermediaries and manufacturers mainly operating in Asia, Europe, and North America. Due to its long-standing status as a generic drug, many manufacturers produce Niclosamide API, often leveraging cost advantages and established quality standards.

1. Asia: The Epicenter of Niclosamide API Production

a. China

China dominates the production landscape owing to its extensive API manufacturing infrastructure, regulatory frameworks aligned with international standards, and competitive pricing. Numerous Chinese companies manufacture Niclosamide API, either for export markets or as intermediaries for global pharmaceutical firms.

Key Chinese Producers:

• Zhejiang Hisun Pharmaceutical Co., Ltd.: A leading enterprise producing a diverse range of APIs, including Niclosamide. The company adheres to GMP standards and exports globally.

• Shenzhen Huitian Biological Technology Co., Ltd.: Specializes in active ingredients and intermediates, with production capacity aligned with GMP requirements.

• Henan Sinotech Pharmaceutical Co., Ltd.: Offers Niclosamide API with regulatory compliance for multiple markets.

b. India

India, leveraging its robust pharmaceutical manufacturing sector, supplies Niclosamide API to global markets, especially in regions where local API manufacturing is preferred for cost or regulatory reasons.

Notable Indian API Suppliers:

• Lark Healthcare: Produces Niclosamide API for domestic and export use, adhering to GMP standards.

• Biological E Limited: Primarily known for vaccines, also supplies critical APIs used in combination therapies, including Niclosamide.

2. Europe and North America

While the European and North American markets have fewer producers of Niclosamide API, they focus on high-quality manufacturing compliant with stringent regulatory standards such as EMA and FDA.

• Sandoz / Novartis (Basel, Switzerland): Known for high-quality generics, including APIs, with strict regulatory oversight.

• CordenPharma: Based in Germany, provides custom manufacturing of APIs to pharmaceutical clients, including Niclosamide, with a focus on GMP compliance.

• Amneal Pharmaceuticals: A US-based generic pharmaceutical company, involved in the sourcing and production of APIs, including Niclosamide, ensuring adherence to quality standards for North American markets.

3. Contract Manufacturing and Custom API Supply

Many pharmaceutical companies opt for contract manufacturing organizations (CMOs) to secure Niclosamide API supply. CMOs such as Lonza, BASF, and Shandong Target Pharmachem Co., Ltd. manufacture APIs on behalf of brand owners or generic companies, providing scalability, quality assurance, and regulatory support.

Regulatory Considerations

Ensuring API quality is paramount, especially given Niclosamide’s burgeoning therapeutic interest. Suppliers should demonstrate compliance with:

• GMP (Good Manufacturing Practices) certification: Validates consistent quality levels.

• Regulatory approvals: From entities such as the US FDA, EMA, or PMDA.

• Certificates of Analysis (CoA): Detailing purity, impurity profile, residual solvents, and other specifications.

• ISO certifications: Ensuring quality management standards.

Securing APIs from reputable sources with international certifications minimizes regulatory risks and facilitates smoother registration processes in target markets.

Key Challenges in Sourcing Niclosamide API

• Supply Chain Disruptions: Global events such as pandemics or geopolitical tensions can impact manufacturing flow, especially in China and India.

• Quality Variability: Differing manufacturing standards necessitate rigorous supplier qualification and batch testing.

• Regulatory Compliance: Suppliers lacking proper certification may pose compliance risks, mandating thorough vetting.

• Pricing Trends: The low-cost manufacturing base in Asia results in competitive pricing, but quality assurance remains a concern requiring due diligence.

Procurement Strategies for Pharmaceutical Companies

To mitigate risks and ensure reliable supply, companies should:

• Engage with multiple qualified suppliers, establishing diversified supply chain channels.

• Prioritize suppliers with strong regulatory track records and GMP certification.

• Implement rigorous supplier qualification processes, including audits and batch testing.

• Negotiate flexible procurement agreements to adapt to fluctuating demand and supply constraints.

• Monitor geopolitical and trade developments impacting key sourcing regions.

Emerging Trends and Future Outlook

The increasing interest in Niclosamide’s therapeutic versatility fuels demand, prompting investments in scalable manufacturing processes and increased capacity expansion, particularly in India and China. Additionally, the rise of contract manufacturing models offers pharmaceutical developers agility in supply chain management.

Advancements in synthetic methodologies, such as process optimization and green chemistry practices, are expected to enhance manufacturing efficiency. Furthermore, regulatory agencies’ acceptance of quality standards applied by Asian suppliers will play a vital role in expanding reliable supply sources.

Conclusion

The bulk API sourcing landscape for Niclosamide hinges predominantly on Chinese and Indian manufacturers, supported by select European and North American suppliers known for stringent quality standards. Pharmaceutical companies must rigorously vet suppliers, emphasizing compliance, quality assurance, and operational reliability, to secure a continuous supply of high-grade Niclosamide API. Strategic diversification and proactive risk management remain essential considering the dynamic nature of global API markets.

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Key Takeaways

• Predominant Sources: China and India lead global Niclosamide API production, offering cost-effective, high-volume manufacturing.

• Quality Assurance: Suppliers with GMP certification and comprehensive regulatory compliance are critical to minimize regulatory hurdles.

• Supply Chain Risks: Diversify suppliers and establish robust qualification processes to mitigate disruptions.

• Emerging Opportunities: Increased demand for Niclosamide due to its potential repurposing creates opportunities for new manufacturing collaborations.

• Strategic Procurement: Engaging CMOs and conducting thorough due diligence enhances supply stability and product quality.

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FAQs

1. What are the primary regions supplying bulk Niclosamide API globally?
China and India are the dominant regions, offering the majority of Niclosamide API production owing to their extensive manufacturing infrastructure and cost advantages. Europe and North America supply smaller quantities, primarily for high-regulatory-compliance applications.

2. How can pharmaceutical companies ensure the quality of imported Niclosamide API?
Companies should verify supplier GMP certifications, review Certificates of Analysis, conduct vendor audits, and perform batch testing upon receipt to ensure compliance with quality standards.

3. Are there regulatory challenges associated with sourcing Niclosamide API from Asian manufacturers?
While many Asian suppliers hold international certifications, discrepancies in documentation or compliance standards may pose regulatory challenges. Due diligence and supplier qualification are essential to mitigate these risks.

4. What role do contract manufacturing organizations play in Niclosamide API supply?
CMOs enable scalable, compliant manufacturing, offering flexibility and capacity expansion. They also assist with regulatory compliance and can streamline procurement processes.

5. How might future developments influence Niclosamide API sourcing?
Advances in manufacturing processes, increased demand from new indications, and evolving regulatory landscapes will likely diversify and expand sourcing options, fostering innovation and supply stability.

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References

[1] World Health Organization. (2022). Guidelines for the quality assurance of active pharmaceutical ingredients.
[2] U.S. Food and Drug Administration. (2023). GMP Regulations for APIs.
[3] IQVIA. (2022). Global Active Pharmaceutical Ingredients Market Report.
[4] Chinese Pharmacopoeia. (2020). Standard for Active Pharmaceutical Ingredients.
[5] European Medicines Agency. (2022). Guidance on API manufacturing accreditation.