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Suppliers and packagers for generic pharmaceutical drug: MOXIDECTIN
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MOXIDECTIN
Introduction
Moxidectin, a macrocyclic lactone antiparasitic agent, has garnered significant attention within veterinary medicine and, more recently, in potential human applications. Initially developed for the treatment of parasitic infections in livestock, moxidectin’s pharmacological profile offers promising therapeutic avenues. Its global supply hinges on key pharmaceutical manufacturers and suppliers, with a complex landscape of patent protections, manufacturing capacities, and regional availability. This article provides a comprehensive overview of current and potential suppliers of moxidectin, examining manufacturing capabilities, regulatory considerations, and market dynamics influencing supply sustainability.
Overview of Moxidectin and its Market Demand
Moxidectin belongs to the macrocyclic lactones class, sharing structural and functional similarities with ivermectin and abamectin. It is approved for use in animals, notably for the treatment of gastrointestinal nematodes and ectoparasites in cattle, sheep, and dogs. The recent shift towards exploring moxidectin for human use, including its potential applications in neglected tropical diseases, has increased demand and necessitated a reliable supply chain.
Market demand for moxidectin is driven by veterinary needs and emergent human health indications. The expanding use cases foster strategic partnerships with manufacturers capable of scaling production in compliance with regulatory standards.
Leading Suppliers and Manufacturers of Moxidectin
1. Pfizer Inc.
Background: Pfizer holds a prominent position as a pioneer and primary supplier in the moxidectin market. Their product, Cydectin, is widely used in veterinary medicine, particularly in cattle and sheep. Pfizer's extensive R&D investments and manufacturing infrastructure position it as a dependable source for moxidectin.
Manufacturing Capabilities: Pfizer operates multiple manufacturing plants globally, including facilities in Europe and North America, adhering to GMP (Good Manufacturing Practice) standards set by regulatory agencies like the FDA and EMA. Their capacity to produce large volumes ensures supply stability.
Regulatory Data: Pfizer’s moxidectin formulations are approved in numerous countries, with regional variations in registration status. Their adherence to high-quality standards and existing regulatory approval streamline distribution and commercialization.
2. Merial (Sanofi) / Boehringer Ingelheim
Background: Although Merial, now part of Boehringer Ingelheim, was involved in the veterinary application of moxidectin, several licensing agreements and collaborations have expanded the supply landscape.
Manufacturing Capabilities: Boehringer Ingelheim has invested in manufacturing capabilities for veterinary anthelmintics, including moxidectin, with facilities in Europe and Asia. Their strategic position in the veterinary pharma sector bolsters supply reliability.
Market Role: Licensing arrangements with Pfizer and others facilitate broader market access, especially in regions where Pfizer’s direct presence is limited.
3. Indian and Chinese Manufacturers
Emerging Suppliers: Several pharmaceutical companies in India and China have started producing generic or locally formulated versions of moxidectin, primarily for veterinary use.
Notable Manufacturers:
- Indian: Companies such as Himalaya Drug Company and Macleods Pharmaceuticals have developed moxidectin formulations, primarily targeting the veterinary segment.
- Chinese: Firms like Harbin Pharmaceutical Group and Shandong Xinhua Pharmaceutical are emerging as regional suppliers.
Regulatory Considerations: Many of these manufacturers are in the process of obtaining approvals for veterinary or human use, with some products cleared by local authorities but not yet internationally recognized.
4. Contract Manufacturing Organizations (CMOs)
Several CMOs specialize in producing macrocyclic lactones for large pharmaceutical firms under confidential agreements. These organizations often possess the capacity to scale up production rapidly in response to market demand.
Supply Chain Challenges and Opportunities
Patent and Exclusivity Barriers: Patent protections by Pfizer and others historically limited immediate generic entry. However, patent expirations, such as those scheduled in the coming years for specific formulations, are opening opportunities for new suppliers.
Regulatory Hurdles: Safety, efficacy, and quality standards pose barriers for new entrants, especially in stringent markets like the US and EU. Regulatory harmonization efforts are critical for expanding supply.
Manufacturing Capacity and Scalability: The global supply of moxidectin depends heavily on Pfizer’s production schedule and capacity for scale-up. During periods of increased demand—for instance, for potential human indications—manufacturers may face bottlenecks.
Regional Supply Dynamics: Emerging markets favor local manufacturers due to lower costs and regional regulations. This regional diversification mitigates supply risks but may introduce variability in quality standards.
Future Outlook and Strategic Considerations
The landscape for moxidectin suppliers is poised for evolution. Patent expiries and increased interest in its applications for human health are expected to catalyze more players entering the market. Partnership opportunities with CMOs, licensing arrangements, and regional manufacturing expansions will be pivotal for ensuring steady supply.
Furthermore, quality assurance and regulatory compliance will remain critical differentiators. Strategic partnerships with established pharmaceutical companies and engagement with regulatory authorities are essential for companies looking to secure or expand their role as moxidectin suppliers.
Key Takeaways
- Pfizer remains the dominant and most reliable global supplier of moxidectin, with extensive manufacturing and regulatory approvals.
- Emerging manufacturers in India and China present increasing regional supply options, though regulatory recognition varies.
- Patent expiries and market demand shifts may facilitate entry for generic and new suppliers.
- Supply stability depends on manufacturing capacity, regulatory compliance, and strategic partnerships with CMOs.
- Future market growth, especially for human indications, demands proactive engagement with regulatory agencies and quality assurance standards.
FAQs
1. Is Pfizer the only manufacturer authorized to produce moxidectin?
No, besides Pfizer, other pharmaceutical companies, particularly in India and China, produce moxidectin for veterinary use. However, Pfizer remains the most prominent global supplier with extensive regulatory approvals.
2. Are generic versions of moxidectin available?
Generic versions are emerging, especially in regions where patent protection has expired or is about to expire. These are primarily for veterinary indications and may face regulatory hurdles for human use.
3. Can moxidectin be used in humans currently?
While primarily approved for veterinary applications, clinical trials and research are exploring its utility in human neglected tropical diseases. Regulatory approval for human use is pending, and supply for such indications would depend on clinical outcomes and approval.
4. What are the key factors influencing supply stability of moxidectin?
Manufacturing capacity, patent rights, regulatory approvals, regional manufacturing capabilities, and global demand fluctuations are the primary factors impacting supply stability.
5. How might future patent expiries influence the moxidectin supply market?
Patent expiries can enable generic manufacturers to enter the market, increasing competition, supply volume, and potentially lowering prices. This expansion could diversify supply sources and enhance global availability.
References
- World Health Organization. "Moxidectin in the treatment of river blindness." WHO Report, 2021.
- Pfizer Inc. "Cydectin Specification and Regulatory Data," Pfizer Documentation, 2022.
- European Medicines Agency. "Summary of Product Characteristics: Moxidectin for Veterinary Use," EMA, 2022.
- Boehringer Ingelheim. "Veterinary Pharmaceuticals Portfolio," Boehringer Ingelheim, 2023.
- Indian Pharmaceutical Industry Reports. "Emerging Trends in Macrocyclic Lactones Production," 2022.
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