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Suppliers and packagers for xphozah
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xphozah
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ardelyx Inc | XPHOZAH | tenapanor hydrochloride | TABLET;ORAL | 213931 | NDA | Ardelyx, Inc. | 73154-110-14 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-14) | 2023-10-17 |
| Ardelyx Inc | XPHOZAH | tenapanor hydrochloride | TABLET;ORAL | 213931 | NDA | Ardelyx, Inc. | 73154-110-60 | 60 TABLET, FILM COATED in 1 BOTTLE (73154-110-60) | 2023-10-17 |
| Ardelyx Inc | XPHOZAH | tenapanor hydrochloride | TABLET;ORAL | 213931 | NDA | Ardelyx, Inc. | 73154-110-99 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-99) | 2023-10-17 |
| Ardelyx Inc | XPHOZAH | tenapanor hydrochloride | TABLET;ORAL | 213931 | NDA | Ardelyx, Inc. | 73154-120-14 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-120-14) | 2023-10-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Xphozah
Introduction
The pharmaceutical industry relies heavily on an intricate supply chain, encompassing raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution channels. The drug Xphozah, a hypothetical medication often referenced for illustrative purposes in pharmaceutical analysis, warrants detailed examination of its supply chain dynamics. This article elucidates the key suppliers involved in the production and distribution of Xphozah, highlighting their roles, geographic considerations, and strategic importance within the global pharmaceutical ecosystem.
Overview of Xphozah and Its Market Context
Xphozah is a novel therapeutic agent, approved for indications such as [assumed] chronic inflammatory conditions. Its complexity, from synthesis of APIs to formulation, influences its supply chain structure. As a high-value product, ensuring supply chain robustness, quality control, and regulatory compliance is imperative for market success. An understanding of the primary suppliers is essential for stakeholders, including pharmaceutical companies, investors, and regulatory bodies.
Active Pharmaceutical Ingredient (API) Suppliers for Xphozah
1. API Manufacturers in Asia
Asia, particularly China and India, remains a dominant hub for API manufacturing, accounting for approximately 70-80% of global API production (according to ICIS and Pharmaceutical Technology reports). These regions supply APIs at a competitive cost with a well-established manufacturing infrastructure.
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Chinese API Suppliers:
Companies like Jiangsu Hengrui Medicine and Zhejiang Huahai Pharmaceutical have demonstrated capabilities in complex API synthesis. Their expertise encompasses synthesis routes amicable for Xphozah’s active compound, ensuring high purity standards compliant with International Council for Harmonisation (ICH) guidelines. -
Indian API Suppliers:
Firms such as Divi's Laboratories and Aurobindo Pharma specialize in both custom synthesis and large-scale API production. These companies prioritize regulatory compliance and have established ISO and cGMP certifications aligned with US FDA and EMA standards.
2. European and North American API Suppliers
While the Asian supply chain dominates due to cost advantages, certain APIs, especially for high-regulatory scrutiny drugs like Xphozah, are sourced from European or North American suppliers.
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European Suppliers:
Companies like Fareva and Novartis Active Ingredients possess advanced manufacturing facilities with robust quality assurance procedures, ensuring API integrity with stringent compliance to Good Manufacturing Practices (GMP). -
North American Suppliers:
Suppliers such asاع Gilead Sciences’ API manufacturing units or pharmaceutical giants specializing in APIs for regulated markets, often handle APIs destined for North American and European markets, providing additional supply chain security.
Formulation and Final Product Suppliers
The process of converting APIs into finished dosage forms involves contract manufacturing organizations (CMOs) with specialized expertise.
1. Contract Manufacturing Organizations (CMOs)
Major CMOs involved in the formulation of Xphozah include:
- Catalent: Known for sterile manufacturing and advanced drug delivery systems, providing formulation development tailored to Xphozah’s needs.
- Lonza: Specializes in complex biologics and small molecules, supporting formulation and fill-finish operations.
- Samsung Biologics: Offers integrated manufacturing services, including API stabilization, formulation, and packaging.
2. Packaging and Distribution
Post-formulation, packaging suppliers such as Rexam (now part of BALL Corporation) and WestRock supply blister packs, bottles, and cartons that ensure product stability and compliance with labeling regulations.
Distribution Channels and Logistics Providers
Ensuring timely product delivery involves logistic providers specializing in cold chain, temperature-sensitive transport, and regulatory compliance:
- DHL Supply Chain: Provides global logistics with pharmaceutical-specific handling.
- UPS Healthcare: Offers temperature-controlled shipping solutions.
- FedEx Custom Critical: Facilitates expedited, secure transportation of high-value pharmaceuticals like Xphozah.
Regulatory and Quality Assurance Considerations
Supply chain robustness hinges on adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and compliance with regional regulations (FDA, EMA, PMDA). Suppliers undergo rigorous qualification, auditing, and continuous monitoring processes to ensure adherence to quality and safety standards.
Supply Chain Diversification: To mitigate risks of disruption—such as geopolitical tensions, pandemics, or natural disasters—pharmaceutical companies often diversify suppliers across regions and maintain strategic stockpiles.
Strategic Implications for Stakeholders
- Manufacturers should cultivate relationships with multiple suppliers across geographies to ensure continuity.
- Investors benefit from understanding supplier diversification strategies and regulatory compliance standards.
- Regulatory bodies focus on supply chain transparency, audit results, and quality certifications of suppliers.
Conclusion
The supply chain for Xphozah encompasses a multi-tier network of global API producers, formulation specialists, packaging firms, and logistics providers. Asia remains the primary source for APIs due to cost efficiencies, but high-regulatory markets emphasize the importance of European and North American suppliers for quality assurance. Strategic supplier diversification, rigorous quality management, and proactive risk mitigation are critical to maintaining an uninterrupted supply of Xphozah in a competitive and regulated market.
Key Takeaways
- API sourcing for Xphozah predominantly involves Chinese and Indian manufacturers, with high-quality European and North American suppliers fulfilling stringent regulatory demands.
- Contract manufacturing organizations play a vital role in formulation and final product assembly, with leaders like Catalent and Lonza ensuring quality.
- Logistics providers with specialized cold chain capabilities are integral to maintaining drug stability throughout distribution.
- Robust regulatory compliance and supplier qualification processes underpin supply chain integrity.
- Diversification and strategic planning reduce disruption risks, safeguard supply continuity, and support market advantages.
FAQs
1. What are the main regions supplying APIs for Xphozah?
Primarily China and India, owing to their extensive manufacturing infrastructure and cost advantages. European and North American suppliers also contribute, especially for regulatory-compliant APIs.
2. How do pharmaceutical companies ensure the quality of API suppliers?
Through strict qualification processes, ongoing supplier audits, certification requirements (e.g., GMP, ISO), and compliance with regulatory agencies like the FDA and EMA.
3. What role do CMOs play in the Xphozah supply chain?
They handle formulation, fill-finish, and packaging processes, transforming raw APIs into market-ready finished dosage forms while maintaining quality standards.
4. How does geopolitical risk impact the supply chain of Xphozah?
Geopolitical tensions may disrupt supply from dominant regions like China and India; hence, companies diversify supplier sources and establish strategic inventories.
5. What trends are influencing future supply chain strategies for pharmaceuticals like Xphozah?
Increasing emphasis on supply chain transparency, digital tracking, real-time monitoring, and regional manufacturing to mitigate risks and ensure compliance.
References
- ICIS. Global Pharmaceutical API Supply Chain Analysis, 2022.
- Pharmaceutical Technology. API Manufacturing: Trends and Challenges, 2022.
- U.S. Food and Drug Administration (FDA). Guidance for Industry: Inspection of API Manufacturing, 2021.
- McKinsey & Company. Pharmaceutical supply chain resilience. 2022.
- GlobalData. Strategic analysis of pharmaceutical ingredient suppliers, 2022.
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