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

Bulk Active Pharmaceutical Ingredient (API) Sources for Niclosamide

Last updated: February 19, 2026

This report analyzes the global landscape of bulk active pharmaceutical ingredient (API) sourcing for niclosamide, a key component in anthelminthic and molluscicidal treatments. The analysis focuses on identifying active manufacturers, their production capacities, regulatory compliance, and geographical distribution.

Who are the Primary Manufacturers of Niclosamide API?

Multiple entities globally produce niclosamide API. Key players identified include companies in China and India, which dominate the API manufacturing sector due to established chemical synthesis infrastructure and cost advantages.

• Nanjing Duomei Biotechnology Co., Ltd. (China): A significant producer with a stated focus on veterinary APIs, including niclosamide.
• Anhui Fengxing Chemical Co., Ltd. (China): Reports indicate production of niclosamide, often serving both domestic and international markets.
• Qingdao Vigor Pharmaceutical Co., Ltd. (China): Listed as a supplier of niclosamide API.
• Shriram Solvex Pvt. Ltd. (India): A chemical manufacturing company that includes niclosamide in its product portfolio.
• Krishna Phyto Product (India): Another Indian entity reported to be a producer of niclosamide.
• Hubei Yuancheng Technology Co., Ltd. (China): Operates in the fine chemical and pharmaceutical intermediate space, listing niclosamide.
• Henan Tianfu pharmaceutical Co., Ltd. (China): Produces various pharmaceutical ingredients, with niclosamide identified.

The exact production volumes for each manufacturer are proprietary. However, market intelligence suggests that Chinese manufacturers, in particular, possess substantial capacity, capable of meeting significant global demand.

What is the Regulatory Status of Niclosamide API Production?

Niclosamide API production is subject to stringent regulatory oversight by national and international health authorities. Manufacturers must comply with Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy.

• Good Manufacturing Practices (GMP): Facilities producing niclosamide API are expected to adhere to GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). GMP compliance is typically verified through site inspections and audits.
• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, quality control, and facility. Drug product manufacturers reference these DMFs in their marketing authorization applications.
• Certificates of Suitability (CEPs): In Europe, CEPs issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) demonstrate that the quality of a substance is suitably controlled by the relevant monograph of the European Pharmacopoeia.
• Country-Specific Registrations: Manufacturers may need to register their APIs with individual national drug regulatory authorities in the countries where their products will be used. This can involve local audits and submission of specific documentation.

The availability of niclosamide API from suppliers with established GMP certifications and filed DMFs is critical for pharmaceutical companies seeking to market finished drug products globally.

What are the Key Chemical Specifications and Quality Control Parameters for Niclosamide API?

Niclosamide API must meet defined chemical specifications to ensure its suitability for pharmaceutical formulations. These specifications are typically outlined in pharmacopoeial monographs or defined by the manufacturer and agreed upon with the drug product manufacturer.

• Chemical Name: 5-Chloro-N-(2-chloro-4-nitrophenyl)-2-hydroxybenzamide
• Molecular Formula: C13H8Cl2N2O4
• Molecular Weight: 327.12 g/mol
• Appearance: Typically a pale yellow to yellow crystalline powder.
• Assay: The purity of niclosamide API is a critical parameter, usually specified as not less than 98.0% and not more than 101.0% on a dried basis.
• Identification: Tests may include Infrared (IR) spectroscopy and High-Performance Liquid Chromatography (HPLC) to confirm the identity of the substance.
• Related Substances/Impurities: Limits are set for specific known impurities and total impurities. This is a crucial aspect of quality control, as impurities can affect the safety and efficacy of the final drug product. Common impurities might arise from the synthesis process.
• Loss on Drying/Water Content: Limits on moisture content are essential for API stability and accurate dosing.
• Residue on Ignition/Sulfated Ash: This test measures inorganic impurities.
• Heavy Metals: Limits for heavy metals are specified to ensure the absence of toxic contaminants.
• Residual Solvents: If solvents are used in the manufacturing process, their residual levels must be controlled and meet defined limits, often based on International Council for Harmonisation (ICH) guidelines.

Manufacturers employ a range of analytical techniques, including HPLC, Gas Chromatography (GC), spectroscopy, and titration, to ensure adherence to these specifications.

What is the Global Supply Chain and Demand Outlook for Niclosamide API?

The supply chain for niclosamide API is largely concentrated in Asia, with China and India being the dominant manufacturing hubs. Demand is driven by its use in human and veterinary medicine, as well as its application as a molluscicide.

• Geographical Concentration: Over 80% of global bulk API production, including niclosamide, is estimated to originate from China and India. This concentration presents both opportunities for cost-effective sourcing and risks related to supply chain disruptions.
• Demand Drivers:
  • Human Medicine: Niclosamide is listed on the World Health Organization's List of Essential Medicines for the treatment of tapeworm infections. Demand is linked to public health programs and the prevalence of parasitic infections.
  • Veterinary Medicine: Used to treat tapeworm infections in livestock and companion animals.
  • Molluscicide: Crucial in controlling snail populations that transmit schistosomiasis, particularly in tropical and subtropical regions. This application is significant for public health initiatives.
  • Emerging Applications: Research into niclosamide's potential as an antiviral, antibacterial, and anti-cancer agent could influence future demand, although these applications are largely in preclinical or early clinical stages.
• Supply Chain Risks: Geopolitical factors, trade policies, environmental regulations in manufacturing countries, and global health crises (like pandemics) can impact the stability and availability of niclosamide API. Diversification of sourcing strategies by drug product manufacturers is a growing consideration.
• Pricing: API pricing is influenced by raw material costs, manufacturing complexity, regulatory compliance overhead, and market competition. Prices can fluctuate based on supply-demand dynamics.

What are the Key Considerations for Sourcing Niclosamide API?

Procuring niclosamide API requires a rigorous due diligence process to ensure product quality, regulatory compliance, and supply chain reliability.

• Supplier Qualification:
  • Regulatory Compliance: Verify GMP certification status with relevant authorities (FDA, EMA, WHO). Request copies of recent inspection reports and audit findings.
  • Quality Management System (QMS): Assess the robustness of the supplier's QMS. This includes their procedures for change control, deviation management, CAPA (Corrective and Preventive Actions), and out-of-specification investigations.
  • Technical Capabilities: Evaluate the supplier's manufacturing process, analytical testing capabilities, and historical performance data.
  • Financial Stability: Ensure the supplier is financially sound to guarantee consistent production.
• Product Quality:
  • Specification Alignment: Confirm that the supplier's product specifications meet or exceed pharmacopoeial standards (e.g., USP, EP) or agreed-upon internal specifications.
  • Impurity Profiling: Request detailed impurity profiles and analytical methods. Understand the potential impact of any identified impurities on the final drug product.
  • Stability Data: Review the API's stability data under various storage conditions.
• Supply Chain Reliability:
  • Capacity Assessment: Understand the supplier's current production capacity and their ability to scale up to meet future demand.
  • Lead Times: Establish realistic lead times for orders and inquire about buffer stock policies.
  • Business Continuity Plan: Inquire about the supplier's plans to mitigate disruptions (e.g., alternative raw material sourcing, redundant manufacturing sites).
  • Geographic Diversification: Consider sourcing from multiple suppliers located in different geographical regions to reduce reliance on a single source.
• Intellectual Property and Contractual Agreements:
  • DMF Access: Ensure timely access to relevant DMFs or equivalent documentation.
  • Supply Agreements: Negotiate comprehensive supply agreements that clearly define quality standards, delivery terms, pricing, force majeure clauses, and termination conditions.

Key Takeaways

• Global niclosamide API production is concentrated in China and India, with several established manufacturers.
• Regulatory compliance, particularly adherence to GMP, is paramount. API suppliers should possess or be pursuing relevant certifications and filings (DMFs, CEPs).
• Niclosamide API quality is defined by strict specifications for purity, impurities, and physical characteristics, verified through validated analytical methods.
• Demand for niclosamide API is driven by its established use in antiparasitic treatments and molluscicidal applications, with potential for growth from emerging research.
• Strategic sourcing requires thorough supplier qualification, verification of quality systems, and robust supply chain risk assessment.

Frequently Asked Questions

1. Can niclosamide API be sourced with a USP or EP monograph? Yes, niclosamide is typically manufactured to meet the specifications outlined in major pharmacopoeias such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP).

2. What is the typical shelf life of niclosamide API? The typical shelf life of niclosamide API is generally two to three years when stored under recommended conditions (e.g., protected from light and moisture in a well-closed container). Specific retest dates are provided by the manufacturer based on stability studies.

3. Are there any major supply chain vulnerabilities specifically for niclosamide API? As with many APIs, supply chain vulnerabilities can arise from reliance on single-region manufacturing, fluctuations in raw material costs, stringent environmental regulations impacting production, and global logistical challenges.

4. What are the primary synthesis routes for niclosamide API, and do they present specific impurity concerns? The common synthesis route involves the reaction of 5-chlorosalicylic acid with 2-chloro-4-nitroaniline. Potential impurities can stem from unreacted starting materials, by-products of the condensation reaction, or degradation products. Manufacturers' impurity profiles address these.

5. How can a pharmaceutical company ensure a stable supply of niclosamide API given potential geopolitical risks? Pharmaceutical companies can mitigate geopolitical risks by qualifying multiple suppliers in different regions, establishing long-term supply agreements with clear risk-sharing clauses, and maintaining strategic inventory levels.

Citations

[1] World Health Organization. (2023). World Health Organization Model List of Essential Medicines. Retrieved from [WHO Website] (Note: Specific URL may change, search "WHO Model List Essential Medicines") [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from [EDQM Website] (Note: Specific URL may change) [3] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP) Information. Retrieved from [FDA Website] (Note: Specific URL may change) [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Harmonised Tripartite Guideline: Impurities: Guidelines for Residual Solvents Q3C(R8). Retrieved from [ICH Website] (Note: Specific URL may change)