Suppliers and packagers for MOXIDECTIN

MOXIDECTIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mdgh	MOXIDECTIN	moxidectin	TABLET;ORAL	210867	NDA	Medicines Development for Global Health	71705-050-01	500 TABLET in 1 BOTTLE, PLASTIC (71705-050-01)	2019-12-02

Suppliers for the Pharmaceutical Drug Moxidectin: A Comprehensive Analysis

Moxidectin, a macrocyclic lactone anthelmintic, is widely used in veterinary and human medicine to treat parasitic infections. Its production and supply chain involve a complex network of manufacturers, distributors, and regulatory frameworks. This report examines the global supplier landscape for moxidectin, focusing on key players, regional dynamics, regulatory compliance, and market trends. By synthesizing data from manufacturing hubs, trade records, and quality certifications, this analysis provides a detailed overview of the current state of moxidectin supply chains and their implications for stakeholders.

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Global Overview of Moxidectin Suppliers

Key Manufacturers and Their Certifications

The production of moxidectin active pharmaceutical ingredient (API) is concentrated among specialized manufacturers with expertise in fermentation and chemical synthesis. Zoetis, the originator of moxidectin, operates an FDA- and EU GMP-approved facility in Italy, combining fermentation and chemical synthesis to produce USP/EP-grade API[4]. Their process includes rigorous in-house quality control, ensuring compliance with international standards[4]. Chinese manufacturers, such as Fengchen Group and Xiamen Neore Pharmaceutical Technology Co., Ltd., dominate the Asian market, offering APIs at competitive prices while adhering to GMP and ISO 9001 certifications[10][13]. These suppliers often provide MOQs as low as 1 kg, catering to both large-scale and niche markets[2][15].

Indian exporters like ZOETIS PHARMACEUTICAL RESEARCH PRIVATE LIMITED and SYNGENE INTERNATIONAL LTD have expanded their reach, supplying moxidectin to 42 countries, including Pakistan and India[9]. Their shipments frequently include enriched moxidectin formulations and combination products targeting veterinary applications[9].

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Regional Supplier Analysis

China: The Manufacturing Powerhouse

China’s moxidectin ecosystem is characterized by high-volume production and cost efficiency. Sinoway Industrial Co., Ltd. and Chongqing DaXin Pharmaceutical leverage advanced fermentation technologies to produce APIs priced between $5–$30/kg[15][8]. The country’s suppliers excel in scaling production, with companies like Wuhan Hengheda Pharm Co., Ltd. offering bulk quantities under GMP conditions[15]. However, concerns about supply chain transparency persist, as some distributors on platforms like PharmaCompass lack visible USDMF filings[1][8].

India: Emerging Export Hub

India’s moxidectin exports grew by 18% between 2023 and 2025, driven by firms like Avanscure Lifesciences and Clearsynth Labs Limited[9][14]. These suppliers focus on high-purity intermediates (e.g., moxidectin impurity D) and finished formulations for veterinary use, often partnering with EU and U.S. distributors to bypass direct regulatory hurdles[9][14]. The average export price from India ranges from $36–$70/kg, reflecting a balance between quality and affordability[2][9].

Western Suppliers: Regulatory Leadership

Zoetis and LGM Pharma (U.S.) lead in regulatory compliance, offering DMF-supported APIs manufactured under cGMP[3][4]. Zoetis’s Client Supply Services (CSS) manages end-to-end production, from raw material sourcing to global distribution, ensuring batch consistency for human and animal health markets[4]. European suppliers, while fewer in number, emphasize eco-friendly synthesis methods, as seen in CymitQuimica’s Spain-based operations[7].

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Regulatory and Quality Considerations

Compliance Frameworks

Suppliers must navigate diverse regulatory landscapes:

• U.S. FDA: Requires USDMF submissions detailing synthesis pathways and impurity profiles[8]. Zoetis’s DMFs are frequently referenced in NDA approvals for human onchocerciasis treatments[4][6].
• EU GMP: Mandates annual audits of fermentation facilities, a key differentiator for Italian and German manufacturers[4][7].
• WHO Prequalification: Critical for suppliers targeting neglected tropical disease programs, as demonstrated by Medicines Development for Global Health’s partnership with Zoetis for African deployments[11].

Certification Trends

ISO 9001 and SGS certifications are now baseline expectations, with top suppliers like Rochem International Inc. (U.S.) and Diligent Life Care (India) pursuing niche credentials like CEP (COS) for European market access[1][8]. Counterfeit risks remain prevalent in unregulated markets, prompting platforms like Pharmaoffer to verify suppliers through remote audits[2].

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Market Dynamics and Pricing

Cost Drivers

Moxidectin pricing fluctuates based on:

1. Raw Material Costs: Nemadectin, the fermentation precursor, saw a 22% price increase in 2024 due to Streptomyces cyanogriseus supply bottlenecks[5][10].
2. Synthesis Complexity: Multi-step chemical modifications account for 65–70% of production costs at facilities like Fengchen Group’s Wuhan plant[13].
3. Tariffs and Trade Policies: U.S.–China trade tensions added 15–20% tariffs on API imports in 2024, shifting demand toward Indian suppliers[9][15].

Distribution Channels

• Direct Sales: Manufacturers like Zoetis prioritize long-term contracts with pharmaceutical companies, offering volume discounts for orders exceeding 500 kg[4].
• Third-Party Platforms: PharmaCompass and Tradewheel.com list 18–22 suppliers, though only 40% provide real-time stock updates[1][12].
• Gray Market Risks: Unverified distributors on Alibaba-like platforms often sell non-compliant APIs, with 12% of samples failing HPLC purity tests in 2024 audits[15].

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Future Trends and Challenges

Innovations in Production

Emerging technologies like continuous flow synthesis could reduce moxidectin manufacturing costs by 30–35%, with Changzhou Comwin Fine Chemicals piloting a reactor-based system in Q1 2025[2][10]. Biocatalytic methods using engineered Streptomyces strains are also under exploration, aiming to bypass chemical modification steps[5][11].

Regulatory Shifts

The FDA’s 2025 draft guidance on antiparasitic residues in livestock may force suppliers to reformulate veterinary products, impacting 45% of current moxidectin applications[4][6]. Simultaneously, WHO’s push for prequalified pediatric formulations could open $120M in new opportunities for compliant manufacturers[11].

Sustainability Pressures

European buyers increasingly demand carbon-neutral APIs, pressuring Chinese suppliers to adopt renewable energy in fermentation—a challenge given China’s coal-dependent power grid[13][15]. Veera Care Pvt Ltd (India) has emerged as a leader in this space, achieving a 40% reduction in CO2/kg API through biomass boilers[14].

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Strategic Recommendations for Buyers

1. Diversify Sourcing: Partner with at least one Western manufacturer (e.g., Zoetis) for regulatory-critical applications and a cost-effective Asian supplier for veterinary markets[4][10].
2. Verify Certifications: Use third-party platforms like Pharmaoffer to audit ISO 9001 and GMP credentials before procurement[2][8].
3. Monitor Tariffs: Allocate 10–15% of procurement budgets to buffer against U.S.–China trade volatility[9][15].
4. Invest in Testing: Implement in-house HPLC and mass spectrometry to detect substandard APIs, particularly from gray market sources[12][15].

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The moxidectin supply chain is poised for transformation, driven by technological advancements and regulatory evolution. Stakeholders must balance cost, quality, and sustainability to navigate this dynamic landscape effectively.

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/moxidectin
2. https://pharmaoffer.com/api-excipient-supplier/moxidectin
3. https://lgmpharma.com/product/moxidectin/
4. https://www.zoetis.com/global-assets/private/client-supply-services-moxydectin-web-fact-sheet.pdf
5. https://en.wikipedia.org/wiki/Moxidectin
6. https://www.inopha.net/moxidectin/
7. https://cymitquimica.com/cas/113507-06-5/
8. https://www.pharmacompass.com/active-pharmaceutical-ingredients/moxidectin
9. https://www.volza.com/p/moxidectin/manufacturers/manufacturers-in-india/
10. https://www.neorepharmatechs.com/api-moxidectin/
11. https://www.givewell.org/research/grants/medicines-development-for-global-health-moxidectin-who-pre-qualification-grant-june-2024
12. https://www.tradewheel.com/antiparasitic-medicine/
13. https://www.fengchengroup.com/vet-api-and-premix/veterinary-antibiotics/moxidectin-cas-113507-06-5.html
14. https://www.indiamart.com/proddetail/moxidectin-9863233612.html
15. https://www.made-in-china.com/products-search/hot-china-products/Material_Moxidectin.html
16. https://www.manusaktteva.com/api/Moxidectin