Bulk Pharmaceutical API Sources for NICLOCIDE

Bulk Pharmaceutical API Sources for NICLOCIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		N3510_SIGMA
Vitas-M Laboratory		STK396676
Molport		MolPort-000-181-408
AKos Consulting & Solutions		AKOS003589004
Vitas-M Laboratory		BBL004110
Amadis Chemical		A828227

Bulk Active Pharmaceutical Ingredient (API) Sources for NICLOCIDE

Last updated: July 30, 2025

Introduction

NICLOCIDE (niclosamide) has garnered renewed interest as a potential therapeutic agent beyond its traditional use as an antiparasitic. Its repurposing for antiviral, anti-inflammatory, and anticancer applications has driven increased demand for high-quality bulk Active Pharmaceutical Ingredient (API). Identifying credible sources for sourcing NICLOCIDE API is crucial for pharmaceutical manufacturers, research institutions, and biotech firms aiming to develop or commercialize NICLOCIDE-based therapies.

This report provides a comprehensive overview of current global suppliers of NICLOCIDE API, emphasizing their manufacturing capabilities, quality standards, regulatory compliance, and supply reliability.

Understanding NICLOCIDE as an API

Niclosamide is a chlorinated salicylanilide compound traditionally prescribed to treat tapeworm infections. Its mechanism involves uncoupling oxidative phosphorylation in parasites, leading to death. Recently, in vitro and in vivo studies suggest NICLOCIDE exhibits antiviral activity, notably against coronaviruses like SARS-CoV-2, and demonstrates anti-inflammatory properties, opening avenues for novel indications.

The quality of bulk NICLOCIDE API is pivotal, with stringent compliance to pharmacopeial standards such as USP, EP, or JP, ensuring impurity profiles, potency, and stability align with regulatory expectations.

Global API Manufacturing Landscape for NICLOCIDE

1. Chinese Suppliers

China remains the dominant hub for bulk API manufacturing, including NICLOCIDE, owing to its extensive API production infrastructure and cost advantages.

• Hubei Huida Pharmaceutical Co., Ltd.
  Capable of large-scale NICLOCIDE synthesis; adheres to cGMP standards; supplies to both domestic and international markets.

• Shandong Weifang Pharmaceuticals
  Approximates high-purity NICLOCIDE API production; complies with various international regulatory standards; offers custom synthesis options.

• Jiangxi Huayu Pharmaceutical Co., Ltd.
  Engages in API manufacturing with an emphasis on quality assurance and consistent supply, with certifications such as ISO 9001 and GMP.

Regulatory Status: Many Chinese suppliers hold CFDA (now NMPA) approvals and export licenses, providing confidence in quality and regulatory compliance.

2. Indian API Manufacturers

India’s API sector exhibits robust regulatory oversight through the Central Drugs Standard Control Organization (CDSCO) and certifications aligned with global standards.

• Biological E. Ltd.
  Produces NICLOCIDE API meeting the specifications of USP and EP; employs rigorous quality control and dossier filings for regulatory submissions.

• Aarti Industries Ltd.
  Offers ongoing supply of high-purity NICLOCIDE API; emphasizes cGMP compliance, with certifications including EU-GMP.

• Macleods Pharmaceuticals
  Engages in API manufacturing with an established reputation for regulatory adherence and quality assurance.

Regulatory and Supply Attributes: Many Indian manufacturers possess WHO-GMP certification, facilitating exports to regulated markets.

3. European and North American Manufacturers

Given the increasing demand for high-quality APIs in developed markets, some European and North American manufacturers are entering or expanding into NICLOCIDE production.

• ChemCon (Sweden)
  Provides pharmaceutical-grade APIs, including NICLOCIDE, with an emphasis on regulatory expertise within the EU regulatory framework.

• Cambridge Isotope Laboratories (USA)
  Known mainly for isotopically labeled compounds, it may also serve as a sourcing option for research-grade NICLOCIDE.

Note: These companies focus often on research-grade or custom synthesis rather than large-scale commercial supply.

Criteria for Selecting NICLOCIDE API Suppliers

• Regulatory Compliance: Suppliers should possess GMP certification, and their APIs must meet pharmacopoeial standards (USP, EP, JP). Validity of export licenses and certifications such as ISO 9001, ISO 13485, or equivalent is crucial.

• Quality Control and Certification: Certificates of Analysis (CoA), stability data, impurity profiles, and validation reports ensure batch-to-batch consistency.

• Manufacturing Capacity and Lead Time: For clinical or commercial production, adequate capacity to meet demand with short lead times is essential.

• Pricing and Payment Terms: Competitive pricing aligned with quality standards; transparent payment and shipment terms.

• Supply Reliability: Ability to deliver in consistent quantities over periods, especially critical amid supply chain disruptions.

Supply Chain Considerations

The current geopolitical climate and global supply chain challenges necessitate diversification of sourcing strategies. Companies should consider dual sourcing or regional suppliers with verified compliance to safeguard against shortages.

Regulatory Challenges and Due Diligence

As NICLOCIDE gains interest for new indications, regulatory authorities might require robust data on API sourcing, manufacturing practices, and quality controls. Due diligence includes verifying suppliers’ regulatory filings, GMP certifications, and audit histories.

Emerging Trends and Future Outlook

• Enhanced Production Capabilities: Investment by manufacturers to scale up NICLOCIDE API production, aiming to meet anticipated pharmaceutical demand.

• Quality Standard Upgrades: Suppliers are adopting stricter quality standards, including ISO certification and comprehensive impurity analyses, aligning with evolving regulatory requirements.

• Sustainability and Green Synthesis: Some manufacturers explore environmentally friendly synthesis routes to reduce ecological footprints, aligning with global sustainability initiatives.

Key Takeaways

• The Chinese and Indian markets dominate NICLOCIDE API supply, offering a broad spectrum of options with varying certifications and quality standards.

• Regulatory compliance, including GMP certification and pharmacopoeial adherence, is paramount for sourcing APIs for clinical or commercial use.

• Diversifying sources and emphasizing supply chain resilience can mitigate risks associated with geopolitical and logistical disruptions.

• Upgrading quality assurance processes and engaging with reputable suppliers ensure consistency and regulatory acceptance.

• Emerging production capacities and sustainable manufacturing practices will likely influence future sourcing strategies.

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FAQs

1. Are Chinese NICLOCIDE API suppliers compliant with international quality standards?
Many Chinese API manufacturers operate under GMP certification and export licenses that meet international standards (e.g., WHO-GMP, cGMP), ensuring suitability for regulated markets. However, due diligence and validation of certificates are essential.

2. Can Indian API manufacturers supply NICLOCIDE at large scales?
Yes. Several Indian pharmaceutical companies have established capacities and adhere to global quality standards, capable of supplying NICLOCIDE API in bulk for both clinical and commercial use.

3. What are the primary considerations when selecting a NICLOCIDE API supplier?
Regulatory compliance, quality standards, manufacturing capacity, supply reliability, pricing, and certification authenticity are critical factors.

4. Is there a significant regulatory difference between sourcing from China, India, or Western suppliers?
Western suppliers often have more stringent regulatory oversight, which may facilitate faster approval in certain jurisdictions. Chinese and Indian suppliers, while compliant with international standards, require thorough due diligence to verify certifications and quality control processes.

5. How can I verify a supplier’s quality and regulatory compliance?
Request Certificates of Analysis, GMP certificates, audit reports, and regulatory filings (such as DMF or CEP submissions). Performing supplier audits or third-party inspections further ensures reliability.

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References

[1] U.S. Pharmacopeia National Formulary (USP-NF). Niclosamide monograph, 2022.
[2] European Pharmacopoeia (EP). Niclosamide monograph, 2022.
[3] International Dispensary Association (IDA). API sourcing and certification guidelines.
[4] GlobalData Healthcare Reports. API Market Trends & Forecasts.
[5] Regulatory approvals and certifications from NMPA, CDSCO, and EMA databases.