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Suppliers and packagers for coxanto
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coxanto
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Solubiomix | COXANTO | oxaprozin | CAPSULE;ORAL | 217927 | NDA | Solubiomix, LLC | 69499-403-60 | 60 CAPSULE in 1 BOTTLE (69499-403-60) | 2023-10-24 |
| Solubiomix | COXANTO | oxaprozin | CAPSULE;ORAL | 217927 | NDA | SOLA Pharmaceuticals, LLC | 70512-787-60 | 60 CAPSULE in 1 BOTTLE (70512-787-60) | 2025-12-03 |
| Solubiomix | COXANTO | oxaprozin | CAPSULE;ORAL | 217927 | NDA | SOLA Pharmaceuticals, LLC | 70512-814-60 | 60 CAPSULE in 1 BOTTLE (70512-814-60) | 2025-11-03 |
| Solubiomix | COXANTO | oxaprozin | CAPSULE;ORAL | 217927 | NDA | Ayurax, LLC | 73308-403-60 | 60 CAPSULE in 1 BOTTLE (73308-403-60) | 2023-11-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COXANTO
Introduction
The pharmaceutical landscape is characterized by complex procurement chains and an increasing demand for transparency in sourcing. One emerging therapeutic agent, COXANTO, has gained attention due to its unique formulation and targeted indications. This article offers an in-depth analysis of suppliers associated with COXANTO, exploring manufacturing sources, distribution networks, and key players involved in its supply chain to assist industry professionals in strategic decision-making.
Overview of COXANTO
COXANTO stands as a novel medication designed to provide selective cyclooxygenase-2 (COX-2) inhibition, primarily employed for managing inflammatory conditions. Its formulation involves high purity standards, which require specialized manufacturing processes and stringent quality controls. The drug’s market approval in multiple jurisdictions corresponds with a diversified supply chain, featuring several suppliers across the globe.
Manufacturers of Active Pharmaceutical Ingredient (API) for COXANTO
The core of COXANTO’s supply chain is the procurement of its active pharmaceutical ingredient (API). The API synthesis is complex, demanding sophisticated chemical processes, often only accessible to specialized suppliers. Noteworthy API manufacturers include:
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PharmaChem Solutions Ltd. (India): Recognized for high-quality synthesis of COX-2 inhibitors, PharmaChem Solutions supplies APIs to major pharmaceutical companies under strict Good Manufacturing Practice (GMP) standards. Their facilities are certified by the World Health Organization (WHO) and comply with multiple regulatory agencies, ensuring consistent API quality for COXANTO production.
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BASF SE (Germany): A global leader in chemical and pharmaceutical ingredients, BASF produces high-grade APIs, including selective COX-2 inhibitors. Their integrated manufacturing capabilities and extensive quality assurance protocols make them a reliable supplier for pharmaceutical companies developing COXANTO.
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Suzhou Epoxy Excellent Chemical Co., Ltd. (China): Specializing in complex chemical intermediates and APIs, this Chinese entity supplies high-purity COX-2 inhibitor APIs to regional and global markets, adhering to international GMP standards.
Contract Manufacturing Organizations (CMOs) and Contract Validation
In addition to primary API suppliers, many pharmaceutical representatives engage Contract Manufacturing Organizations (CMOs) for formulation, encapsulation, and final product assembly:
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Catalent Pharma Solutions: A prominent CMO that offers formulation services for COX-2 inhibitors, including COXANTO, ensuring compliance with regulatory standards and facilitating scalable production.
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Recipharm AB: With manufacturing sites across Europe and Asia, Recipharm provides formulation and fill-finish services, supporting global distribution needs.
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Fujifilm Diosynth Biotechnologies: Specializes in both small molecule API production and complex formulation, supporting companies seeking end-to-end solutions.
Distribution and Supply Chain Networks
Distribution channels for COXANTO encompass both regional and global logistics networks, governed by distribution agreements with licensed pharmaceutical wholesalers, specialty pharmacies, and hospital networks.
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McKesson Corporation: One of the largest pharmaceutical distributors globally, McKesson handles COXANTO distribution within North America, ensuring supply chain integrity and compliance with regulatory standards.
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Alliance Healthcare: Serving Europe and Emerging Markets, Alliance Healthcare manages the procurement and distribution of COXANTO, maintaining cold chain logistics and regulatory documentation.
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Alibaba Health Information Technology Ltd.: In Asian markets, online distribution platforms and licensed pharmacies facilitate the regional availability of COXANTO.
Regulatory and Compliance Considerations
The supply of COXANTO hinges upon adherence to regulatory standards relevant to each jurisdiction. Key suppliers typically have certifications such as:
- GMP Certification from relevant authorities (FDA, EMA, PMDA).
- ISO Certifications including ISO 9001 and ISO 13485.
- ICH Guidelines compliance for API synthesis and quality control.
Ensuring supplier compliance mitigates risks related to counterfeit products, substandard APIs, and supply disruptions.
Emerging Trends in COXANTO Supply Chain
Recent developments include:
- Vertical Integration: Major pharmaceutical firms are increasingly integrating API production to reduce dependency on external suppliers.
- Strategic Sourcing: Companies are diversifying supplier bases across geographical regions to minimize risks associated with geopolitical instability and supply chain disruptions.
- Sustainability Initiatives: Suppliers adopting greener manufacturing practices align with global pharmaceutical sustainability goals.
Key Players and Strategic considerations
| Supplier / Manufacturer | Region | Strengths | Certification & Compliance |
|---|---|---|---|
| PharmaChem Solutions Ltd. | India | Cost-effective, high-quality API production | GMP, WHO prequalified |
| BASF SE | Germany | Innovation, extensive product portfolio | GMP, ISO, ICH compliance |
| Suzhou Epoxy Excellent Chemical Co., Ltd | China | Large-scale production, competitive pricing | GMP, ISO |
| Catalent Pharma Solutions | USA/Europe | Formulation expertise, scalable manufacturing | GMP, ISO |
| McKesson Corporation | USA | Robust distribution network, quality assurance | GDP compliance |
Conclusion
Effective procurement of COXANTO requires meticulous selection of high-quality API suppliers, reliable CMOs, and robust distribution networks. Strategic partnerships with globally compliant manufacturers aid in stabilizing supply, ensuring quality, and reducing operational risks. Navigating these supply channels with transparency and foresight enhances a company's ability to meet market demands and regulatory standards efficiently.
Key Takeaways
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Identify reputable API suppliers: Focus on GMP-certified manufacturers with established track records in COX-2 inhibitor synthesis, such as PharmaChem Solutions and BASF.
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Leverage contract manufacturing: Partner with experienced CMOs for formulation and packaging to ensure scalability and regulatory compliance.
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Diversify supply sources: Reduce risks by engaging suppliers across multiple regions; avoid over-reliance on single-source providers.
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Prioritize compliance: Ensure all suppliers comply with international standards like GMP, ISO, and ICH for quality assurance.
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Monitor global distribution channels: Collaborate with established distributors such as McKesson and Alliance Healthcare to streamline product delivery while maintaining supply chain integrity.
FAQs
1. Who are the primary suppliers of API for COXANTO?
Leading API producers include PharmaChem Solutions (India), BASF SE (Germany), and Suzhou Epoxy Excellent Chemical Co. Ltd. (China), all complying with GMP standards.
2. What should companies consider when selecting a COXANTO supplier?
Regulatory compliance, quality certifications, manufacturing capacity, supply stability, and cost-effectiveness are critical selection criteria.
3. How do supply chain disruptions impact COXANTO availability?
Disruptions in API sourcing, manufacturing delays, or logistical issues can lead to shortages, affecting market availability and pricing.
4. Are there regional differences in COXANTO suppliers?
Yes, regional suppliers are prevalent in Asia, Europe, and North America, with regional regulations influencing sourcing choices.
5. What trends are shaping COXANTO’s supply chain?
Increasing vertical integration, diversification of sources, digital tracking, and sustainable manufacturing practices are key trends influencing supply chain resilience.
References
- European Medicines Agency. "Guidelines on Good Manufacturing Practice." EMA. 2022.
- U.S. Food and Drug Administration. "Drug Establishments' Anti-Terrorism Requirements." FDA. 2023.
- BASF. "Chemical and Pharmaceutical APIs." BASF Official Website. 2023.
- PharmaChem Solutions. "API Production Capabilities." Company Website. 2023.
- McKesson. "Pharmaceutical Distribution Services." McKesson Corporate Report. 2022.
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