Bulk Pharmaceutical API Sources for LEVAMISOLE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for LEVAMISOLE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		L9756_SIGMA
Hangzhou Trylead Chemical Technology		TL8001274
NovoSeek		27944
TCI (Tokyo Chemical Industry)		T1215
MolPort		MolPort-003-666-467
ABI Chem		AC1L1EAA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Levamisole Hydrochloride

Last updated: August 2, 2025

---

Introduction

Levamisole hydrochloride is a synthetic anthelmintic agent historically used to treat parasitic worm infections in humans and livestock. Its resurgence in recent years as an adjunct in certain cancer therapies and illicit use as a cutting agent in illicit drugs underscores the importance of reliable API sourcing. Ensuring high-quality, compliant bulk API supplies is critical for manufacturers and healthcare providers to meet regulatory standards, suppress counterfeit risks, and optimize therapeutic outcomes.

This report analyzes the global landscape of bulk API suppliers specializing in levamisole hydrochloride, emphasizing their manufacturing capabilities, regulatory adherence, and market presence.

---

Market Landscape and Key API Suppliers

1. Manufacturing Giants and Regional Leaders

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Zhejiang Hisun is among China's prominent producers of veterinary and pharmaceutical APIs, including levamisole hydrochloride. Their integrated manufacturing processes comply with Good Manufacturing Practices (GMP), and their capacity to produce bulk APIs supports both domestic and export markets. The company has consistently demonstrated adherence to international standards, offering APIs that meet specifications set by regulatory agencies such as the FDA and EMA.

b. Jiangsu Hengrui Medicine Co., Ltd. (China)
A leading Chinese pharmaceutical enterprise, Hengrui manufactures APIs for various therapeutic areas, including antiparasitics like levamisole hydrochloride. Their robust research and development infrastructure facilitate high-purity API production aligned with international quality standards.

c. Jinan Fuhuang Pharmaceutical Co., Ltd. (China)
Specializing in veterinary APIs, Jinan Fuhuang produces levamisole hydrochloride primarily for animal health. Their products are approved by the Chinese CFDA and have gained recognition in global markets for consistent quality.

d. Gansu Sinopharm Chemical Reagents Co., Ltd. (China)
This supplier offers a range of chemical reagents and APIs, including levamisole hydrochloride, primarily targeting the pharmaceutical and research industries. Their manufacturing facilities meet GMP standards, and they have a global distribution network.

2. Regional Suppliers in India and Southeast Asia

a. Alkem Laboratories Ltd. (India)
Alkem's API manufacturing division produces a variety of anthelmintic APIs. They maintain compliance with WHO-GMP standards, serving both domestic and export markets. Their focus on process validation and quality control ensures API batch consistency.

b. Phosphagenics Limited (Australia)
While primarily focused on drug delivery systems, Phosphagenics collaborates with regional API suppliers to source levamisole hydrochloride, emphasizing quality governance and supply chain security.

3. European and North American Contributions

While European and North American providers of levamisole hydrochloride are less prominent, some specialty chemical firms and long-established API producers supply high-grade APIs for research and restricted clinical use:

a. Beijing United Chemical Co., Ltd. (China)
This firm supplies pharmaceutical-grade APIs to a global clientele and maintains ISO certifications for quality assurance.

b. Sigma-Aldrich (now part of Merck KGaA)
Although Sigma-Aldrich offers research-grade levamisole hydrochloride, their focus is primarily on research and development rather than large-scale pharmaceutical manufacturing.

---

Quality, Regulatory, and Supply Chain Considerations

Regulatory Compliance

Suppliers must demonstrate compliance with international standards—GMP, ISO, and certifications such as WHO-GMP or US FDA approval. For APIs intended for human therapeutic use, strict adherence to pharmacopeial specifications (USP, EP, JP) is mandatory. Veterinary APIs possess similar, though sometimes less stringent, regulatory oversight.

Supply Chain Security and Traceability

Due to the widespread use of levamisole hydrochloride in veterinary medicine and its potential for illicit diversion, supply chain transparency is critical. Authentic suppliers provide batch-specific data sheets, Certificate of Analysis (CoA), and traceability information.

Quality Assurance Protocols

Leading suppliers employ rigorous in-process testing, final product validation, and stability studies. They leverage advanced analytical techniques (HPLC, NMR, IR spectroscopy) to confirm API purity (>99%) and impurity profiles within pharmacopeial limits.

Pricing and Market Dynamics

API pricing depends on purity, batch size, and manufacturing complexity. Chinese manufacturers typically offer competitive rates due to lower production costs, though quality verification remains crucial. Supply stability is affected by geopolitical factors and regulatory approvals, impacting procurement strategies.

---

Key Challenges in API Sourcing

• Regulatory Variability: Different regions uphold varying standards; navigating these complexities requires compliance monitoring.
• Quality Assurance: The proliferation of unapproved or low-quality APIs in unregulated markets presents counterfeit risks.
• Supply Chain Disruptions: Political shifts, trade tensions, and pandemic-related logistics issues can hinder consistent API availability.
• Technical Compatibility: Ensuring API specifications align with formulation requirements demands careful supplier evaluation.

---

Emerging Trends and Future Outlook

• Increased Focus on Quality and Traceability: Digital platforms and serialization intend to enhance supply chain transparency for levamisole hydrochloride.
• Shift toward Certified Chinese Suppliers: With China's manufacturing capacity expanding, many companies emphasize GMP compliance and export certifications.
• Regulatory Harmonization: Global movement toward harmonized standards facilitates API approval processes across regions, improving accessibility.
• Potential for Synthetic Innovation: Advances in synthetic chemistry may yield more cost-effective and purer levamisole hydrochloride variants, expanding supplier options.

---

Conclusion

Reliable bulk API sources for levamisole hydrochloride primarily originate in China, supported by a robust manufacturing infrastructure following international quality standards. Indian, Australian, and regional suppliers serve niche or specialized markets, emphasizing quality and compliance. As regulatory landscapes evolve, transparency, consistency, and certification will be crucial differentiators for API suppliers.

---

Key Takeaways

• Chinese manufacturers dominate the levamisole hydrochloride API market, offering cost-effective, high-quality products aligned with global standards.
• Ensuring GMP compliance and thorough quality verification is essential for mitigating risks associated with counterfeit or substandard APIs.
• The increasing importance of supply chain transparency and traceability reflects regulatory and market-driven demands.
• Regional suppliers in India and Australia complement Chinese manufacturers, offering diversification and regional sourcing options.
• Ongoing advancements in synthetic chemistry and digital tracking are poised to enhance the security, quality, and availability of levamisole hydrochloride APIs.

---

FAQs

1. What are the primary regions producing bulk levamisole hydrochloride?
China leads global production, supplemented by India, Australia, and specialized suppliers in North America and Europe.

2. How can buyers verify the quality of levamisole hydrochloride APIs?
Request Certificates of Analysis, review manufacturing certifications (GMP, ISO), and conduct third-party testing for purity and impurities.

3. Are Chinese API suppliers compliant with international standards?
Many Chinese manufacturers adhere to GMP and export certifications; however, due diligence in verifying documentation is advised.

4. What regulatory challenges exist in sourcing levamisole hydrochloride APIs?
Variations in regional standards, documentation requirements, and import/export restrictions necessitate thorough compliance management.

5. Will the demand for levamisole hydrochloride APIs increase?
While traditional use declined, resurgence in medical and illicit markets could sustain or increase demand, emphasizing quality assurance.

---

References
[1] U.S. Pharmacopeia. (2022). Levamisole Hydrochloride Monograph.
[2] World Health Organization. (2019). International Pharmacopoeia - Anthelmintic APIs.
[3] GlobalData. (2023). API Market Analysis: Levamisole Hydrochloride.
[4] Chinese National Medical Products Administration (NMPA). Certification and approval standards.
[5] DrugMaster API Suppliers Directory, 2023.