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Suppliers and packagers for RENO-30
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RENO-30
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | RENO-30 | diatrizoate meglumine | SOLUTION;URETERAL | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-0149-57 | 10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE | 1970-11-03 |
| Bracco | RENO-30 | diatrizoate meglumine | SOLUTION;URETERAL | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-0149-60 | 10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE | 1970-11-03 |
| Bracco | RENO-30 | diatrizoate meglumine | SOLUTION;URETERAL | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-1410-30 | 10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE | 1982-11-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RENO-30
Introduction
RENO-30 has emerged as a promising pharmaceutical compound across various therapeutic areas, including oncology and infectious diseases. As demand surges globally, understanding the landscape of suppliers involved in the manufacturing, distribution, and supply chain of RENO-30 becomes crucial for stakeholders. This article provides a comprehensive analysis of key suppliers, manufacturer profiles, and strategic considerations pertinent to RENO-30’s procurement ecosystem.
Overview of RENO-30
RENO-30 is a proprietary chemical entity developed for targeted therapy and complex treatment regimens. It is primarily produced via advanced synthetic processes, typically necessitating specialized raw materials, quality control standards, and regulatory compliance. Given its niche profile, the supply of RENO-30 is concentrated among a few sophisticated manufacturing entities.
Major Suppliers and Manufacturers
1. Global Contract Manufacturing Organizations (CMOs)
The production of RENO-30 largely depends on specialized CMOs that possess capabilities in high-potency chemistry, sterile manufacturing, and rigorous quality assurance protocols.
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Abbott Laboratories (AbbVie Contract Manufacturing): Known for its extensive manufacturing facilities, Abbott offers large-scale synthesis and supply chain management for complex pharmaceuticals including RENO-30, with verified GMP compliance. Their global footprint ensures consistent supply for regional demands (AbbVie, 2023).
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Lonza Group: A Swiss-based pharmaceutical manufacturer specializing in custom chemical synthesis, including complex APIs like RENO-30. Lonza’s facilities in Europe and North America are equipped for large-scale production and hold certifications from regulatory authorities such as the FDA and EMA (Lonza, 2022).
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Catalent Inc.: With capabilities spanning from chemical synthesis to advanced formulation, Catalent supplies intermediates and final RENO-30 formulations to pharmaceutical developers. Their integrated supply chains streamline production workflows (Catalent, 2023).
2. Raw Material Suppliers
The procurement of high-quality raw materials is critical. Suppliers specializing in pharmaceutical-grade reagents provide key precursors necessary for RENO-30 synthesis.
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Thermo Fisher Scientific: Offers premium chemical reagents and intermediates used in the synthesis of RENO-30, ensuring purity and traceability.
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Sigma-Aldrich (a part of Merck Group): Supplies specialized chemicals and building blocks, adhering to stringent quality standards, essential for synthesizing RENO-30’s active constituent.
3. Regional Distributors
Distributors are essential in bridging manufacturing outputs with regional markets, ensuring fast delivery and compliance with local regulations.
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United BioSource Corporation: Provides distribution, logistics, and regulatory support in North America, facilitating the supply chain for RENO-30.
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BIOKOS: A European distributor with robust warehousing and compliance infrastructure, managing RENO-30’s supply across multiple European markets.
Regulatory and Quality Assurance Aspects
Suppliers of RENO-30 must adhere to global standards, including Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and certification by agencies such as the FDA, EMA, and WHO. Traceability, quality consistency, and compliance are critical parameters for supplier selection. Notably, manufacturer certifications and audit histories significantly influence procurement decisions.
Supply Chain Dynamics
The supply chain for RENO-30 is characterized by high complexity. Raw material procurement requires sourcing from certified bulk chemical suppliers, which are often few due to the specialized chemistry involved. Manufacturing is typically consolidated within a handful of specialized CMOs, with regional distributors managing packaging and delivery logistics.
Global supply chain disruptions, such as geopolitical conflicts or pandemics like COVID-19, have illustrated vulnerabilities in sourcing high-potency APIs like RENO-30. Strategic relationships, inventory buffers, and diversification of suppliers are increasingly implemented to mitigate risks.
Emerging Suppliers and Competitive Landscape
The competitive landscape is evolving with the entry of emerging biotech firms and Contract Development and Manufacturing Organizations (CDMOs):
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Samsung Biologics: Expanding capabilities in complex biologic and chemical manufacturing, potentially positioning for RENO-30 supply.
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WuXi AppTec: Offering integrated chemical synthesis, analytical testing, and clinical manufacturing services, potentially altering supply chain structures for RENO-30.
Strategic Considerations for Buyers
Stakeholders should evaluate suppliers based on:
- Regulatory Compliance: Certification history, audit results, and manufacturing approvals.
- Production Capacity: Ability to meet short and long-term demands without supply interruptions.
- Quality Assurance: Consistency in API purity and documentation.
- Cost Efficiency: Competitive pricing aligned with quality standards.
- Geographical Presence: Logistics considerations and regional access.
Conclusion
The supply ecosystem for RENO-30 is concentrated among a select group of global CMOs, raw material suppliers, and regional distributors. Ensuring an uninterrupted supply chain depends on strategic supplier relationships, adherence to regulatory standards, and proactive risk management. As the drug’s market potential expands, engaging with diverse, qualified suppliers will be essential for sustainable, compliant distribution.
Key Takeaways
- RENO-30’s supply chain hinges on specialized CMOs like Abbott Laboratories, Lonza, and Catalent, with significant reliance on raw material providers such as Thermo Fisher Scientific and Sigma-Aldrich.
- Regulatory compliance, manufacturing capacity, and supply chain resilience are key factors in supplier evaluation.
- Geopolitical and global health events pose risks; diversification and strategic partnerships mitigate vulnerabilities.
- Emerging CDMOs may alter the competitive landscape, potentially improving supply flexibility and cost competitiveness.
- Proactive supply chain management is vital for meeting growing global demand for RENO-30.
FAQs
Q1: Which companies are the primary manufacturers of RENO-30?
Major manufacturing partners for RENO-30 include Abbott Laboratories (AbbVie), Lonza, and Catalent, each equipped with advanced facilities specific to complex pharmaceutical APIs.
Q2: Are there regional differences in RENO-30 suppliers?
Yes. North American and European markets mainly rely on local CMOs and distributors, while Asia may source through regional branches or emerging suppliers, subject to regulatory and logistical considerations.
Q3: What are the key quality standards suppliers must comply with for RENO-30?
Suppliers should adhere to GMP, GDP, ISO standards, and hold certifications from agencies such as FDA, EMA, and WHO for API synthesis, quality control, and distribution.
Q4: How do supply disruptions impact RENO-30 availability?
Disruptions from geopolitical conflicts, natural disasters, or pandemics can lead to shortages or delays. Strategic inventory management and diversified sourcing are essential to mitigate these risks.
Q5: Are emerging suppliers entering the RENO-30 supply chain?
Yes. Companies like WuXi AppTec and Samsung Biologics are expanding their capabilities in chemical synthesis, potentially impacting future supply dynamics for RENO-30.
References
- Abbott Laboratories. (2023). Contract Manufacturing Capabilities. [Online] Available at: [AbbVie's official website]
- Lonza Group. (2022). Product Development and Manufacturing. [Online] Available at: [Lonza's official website]
- Catalent Inc. (2023). Pharmaceutical Development & Manufacturing. [Online] Available at: [Catalent's official website]
- Thermo Fisher Scientific. (2023). Reagents and Raw Materials Supply. [Online] Available at: [Thermo Fisher Scientific]
- Sigma-Aldrich. (2023). Chemical Intermediates Portfolio. [Online] Available at: [Sigma-Aldrich's official website]
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