Bulk Pharmaceutical API Sources for MOXIDECTIN

Bulk Pharmaceutical API Sources for MOXIDECTIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-023-220-662
AbaChemScene		CS-3080
MedChemexpress MCE		HY-B0777
BOC Sciences		113507-06-5

Bulk Active Pharmaceutical Ingredient (API) Sources for: MOXIDECTIN

Last updated: August 6, 2025

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Introduction

Moxidectin is a potent macrocyclic lactone anthelmintic used primarily in veterinary medicine and increasingly in human health for parasitic infections. As a lipophilic compound with a complex chemical structure, sourcing high-quality moxidectin API is integral to pharmaceutical manufacturing, regulatory compliance, and product efficacy. This article provides a comprehensive overview of the global suppliers of moxidectin API, emphasizing quality standards, regulatory approvals, and industry trends critical for pharmaceutical developers and investors.

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Overview of Moxidectin API

Moxidectin (C­­₄HₙClₙOₙ) is characterized by its effectiveness against nematodes and ectoparasites, marking it as a key component in antiparasitic formulations. Its chemical stability, bioavailability, and manufacturing scalability influence API sourcing decisions heavily. Due to its complex synthesis, sourcing reliable APIs requires scrutinized supply chain management to ensure consistency, purity, and regulatory acceptance.

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Global API Manufacturing and Supply Landscape

Leading API Manufacturers

Major manufacturers of moxidectin API span North America, Europe, and Asia, with differentiation often based on manufacturing capacity, quality certifications, and regulatory compliance.

1. LKT Laboratories, Inc. (USA)
LKT Laboratories is a prominent supplier of veterinary APIs, including moxidectin. Their facilities are cGMP-compliant, accredited by the U.S. Food and Drug Administration (FDA), and their APIs often adhere to stringent quality standards crucial for pharmaceutical-grade products. Their focus on stability and purity aligns with pharmaceutical industry requirements, making them a preferred choice for high-quality API sourcing.

2. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)
A rapidly growing manufacturer specializing in antiparasitic APIs, Zhejiang Kangle offers moxidectin intermediates and APIs conforming to pharmacopeial standards. Their production facilities maintain certifications such as ISO 9001 and GMP, ensuring reliable supply and compliance with international regulations.

3. Wintran Technology Co., Ltd. (China)
This company provides bulk moxidectin API with emphasis on cost-effective manufacturing while maintaining quality standards. Their facilities are GMP-certified, and they frequently supply to global API exporters and contract manufacturing organizations (CMOs).

4. Phibro Animal Health Corporation (USA/International)
Phibro supplies veterinary APIs, including moxidectin, mostly for institutional clients. They maintain rigorous quality controls and work closely with regulatory agencies to meet global standards, emphasizing product stability and consistent purity.

5. JW Pharmaceutical Co., Ltd. (South Korea)
Specializing in high-quality veterinary APIs, JW Pharmaceutical offers moxidectin API with certifications aligned with CE and FDA standards. Their facilities ensure scalability and supply chain security, critical for large-volume manufacturing.

Emerging Suppliers and Regional Dynamics

While established players dominate, emerging suppliers in India and Southeast Asia are increasingly entering the market. Companies such as Hetero Labs and Aurobindo Pharma, primarily known for generic pharmaceuticals, have expanded into API manufacturing, including moxidectin. These suppliers often provide competitive pricing but require rigorous validation for regulatory approvals.

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Quality and Regulatory Standards

Ensuring API quality is vital for safety, efficacy, and regulatory approval. Suppliers must comply with Good Manufacturing Practices (GMP) and possess certifications such as:

• FDA Registration: For companies supplying APIs intended for U.S. pharmaceutical use.
• EMA Certification: For suppliers targeting the European market.
• ISO Certifications: ISO 9001, ISO 13485 for quality management, and ISO 17025 for analytical testing laboratories.

Most reputable suppliers of moxidectin API offer detailed Certificates of Analysis (CoA), demonstrating purity levels typically exceeding 98%, residual solvents within permissible limits, and absence of heavy metals or residual impurities.

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Supply Chain Considerations

• Reliability: Long-term partnerships with established manufacturers reduce supply chain disruptions.
• Quantity and Scalability: Capacity to produce API in bulk volumes to meet global demand.
• Pricing: Competitive costs are accessed through regional manufacturers, but cost should not compromise quality.
• Regulatory Support: Suppliers providing comprehensive documentation facilitate registration processes in various jurisdictions.

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Trends and Future Outlook

The market for moxidectin API is experiencing growth driven by increased veterinary use for livestock and potential expansion into human antiparasitic treatments. This expanding demand favors scalable, high-quality suppliers capable of meeting regulatory standards. Additionally, advances in synthetic chemistry and process optimization may reduce manufacturing costs and stimulate new entrants to the API market.

Emerging regulatory pathways, such as WHO prequalification, are also prompting suppliers to emphasize quality assurance and transparency. This trend improves the overall quality landscape and aids pharmaceutical companies in gaining swift regulatory approvals.

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Conclusion

Moxidectin API sourcing hinges on a combination of quality, reliability, regulatory compliance, and cost. Leading suppliers from North America, China, and Korea offer high-grade APIs suitable for pharmaceutical development and commercial manufacturing. Critical evaluation of supplier certifications, track record, and capacity ensures that companies maintain supply chain integrity and meet stringent quality standards.

Key recommendations include establishing relationships with multiple suppliers to mitigate risks, verifying GMP and regulatory compliance, and assessing supply chain stability before long-term procurement commitments.

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Key Takeaways

• Leading suppliers of moxidectin API include LKT Laboratories (USA), Zhejiang Kangle Pharmaceutical (China), and JW Pharmaceutical (South Korea).
• Quality assurance via GMP, ISO, and regulatory certifications (FDA, EMA) remains paramount.
• Emerging regional suppliers offer competitive options; however, rigorous qualification processes are necessary.
• Supply chain resilience depends on diversification, scalable manufacturing capacity, and strong regulatory support.
• The market outlook suggests growing demand, necessitating strategic sourcing from suppliers prepared for increased global volumes.

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FAQs

1. What are the critical quality attributes to consider when sourcing moxidectin API?
High purity (>98%), consistent batch-to-batch reproducibility, compliance with pharmacopeial standards (USP, EP), residual solvent levels within limits, and absence of heavy metals and impurities. Certifications such as GMP are essential.

2. Are Chinese API manufacturers as reliable as Western counterparts for moxidectin?
Many Chinese manufacturers hold GMP and ISO certifications, with some exceeding international quality standards. Due diligence, audits, and verification of regulatory certifications are essential for assessing reliability.

3. How does regulatory approval influence API sourcing decisions?
APIs intended for human or veterinary pharmaceuticals must meet specific regulatory standards. Suppliers with existing approvals from agencies like the FDA or EMA streamline registration processes and reduce compliance risks.

4. What are the cost considerations in API sourcing for moxidectin?
Cost is influenced by manufacturing scale, regional labor and material costs, and quality standards. While Asian suppliers often offer cost advantages, maintaining high-quality standards is crucial to avoid regulatory issues and product recalls.

5. How are future technological advances affecting moxidectin API manufacturing?
Innovations in synthetic chemistry and process engineering are making API synthesis more efficient, potentially reducing costs and environmental impact. This evolution can lead to increased supply, improved purity, and broader accessibility.

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References

1. [1] Moxidectin. WHO International Drug Regulators Program. (2022).
2. [2] LKT Laboratories. Product Certifications and Quality Standards. (2023).
3. [3] Zhejiang Kangle Pharmaceutical Co., Ltd. Manufacturer Profile and Capacity. (2023).
4. [4] Regulatory Guidelines for Antiparasitic APIs. U.S. FDA and EMA publications. (2022).
5. [5] Emerging Trends in Antiparasitic API Market. Market Research Report, 2023.