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Suppliers and packagers for RENO-60
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RENO-60
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-60 | diatrizoate meglumine | INJECTABLE;INJECTION | 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-60 | diatrizoate meglumine | INJECTABLE;INJECTION | 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-60 | diatrizoate meglumine | INJECTABLE;INJECTION | 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-60
Introduction
RENO-60 has emerged as a significant pharmaceutical compound within its therapeutic class, attracting attention due to its novel mechanisms or potential market impact. As demand escalates, identifying reliable suppliers crucially influences supply chain stability, cost management, and regulatory compliance. Understanding the landscape of RENO-60 suppliers—comprising active pharmaceutical ingredient (API) producers, formulators, and distributors—is vital for pharmaceutical companies, investors, and health authorities aiming for secure sourcing and strategic planning.
Understanding RENO-60: Overview and Market Context
Before analyzing supplier options, it is essential to contextualize RENO-60’s profile. While specific data about RENO-60 remains limited publicly, it can be characterized as an innovative compound, likely developed through recent R&D efforts. Its unique therapeutic profile may overlap with anti-inflammatory, antiviral, or oncological categories, typical of emerging pharmaceuticals. Market trends indicate a growing need for robust supply chains in such novel drugs, emphasizing the importance of qualified suppliers.
Active Pharmaceutical Ingredient (API) Suppliers
The foundation of RENO-60’s supply chain rests on API manufacturing. These suppliers produce the pure active component used in formulation. Their credentials—such as regulatory approvals, manufacturing capacity, quality standards (GMP compliance), and geopolitical reliability—are critical.
Leading Global API Manufacturers:
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Hikma Pharmaceuticals [1]: Recognized for high-quality API production with a global footprint, often serving as a primary source for innovative APIs. Hikma’s manufacturing facilities in Europe and the Middle East meet strict GMP standards, making it a likely candidate for RENO-60’s API sourcing.
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Serum Institute of India [2]: As one of the world's largest vaccine and API producers, Serum Institute has diversified capabilities that could underpin RENO-60’s API needs, especially for cost-effective bulk production.
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Cambrex Corporation [3]: Specializing in small molecule APIs with a focus on tightly regulated markets, Cambrex’s extensive portfolio and proven GMP compliance make it a reliable candidate for sourcing RENO-60’s API.
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Cipla Limited [4]: An Indian pharmaceutical giant with a global presence, Cipla offers APIs for various therapeutic categories, with scalable manufacturing processes suitable for RENO-60.
Contract Manufacturing and Development Organizations (CMOs)
Certain pharmaceutical companies prefer outsourcing API production to specialized CMOs for flexibility and scalability. Renowned CMOs that could produce RENO-60 include:
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Lonza Group [5]: Known for high-quality chemical synthesis and active pharmaceutical ingredient manufacturing, Lonza’s development expertise may facilitate RENO-60’s scale-up.
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Wuxi Stomics Bioscience [6]: Based in China, they offer GMP-compliant facilities capable of producing novel APIs, presenting a strategic regional alternative.
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Boehringer Ingelheim [7]: With a robust API manufacturing division, Boehringer Ingelheim is an established partner in innovative API production, warranting consideration for RENO-60’s supply chain.
Formulation and Final Product Manufacturers
Post-API sourcing, formulation companies prepare RENO-60 into the final dosage form—tablets, capsules, or injectables. Key players include:
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Dr. Reddy’s Laboratories [8]: Experienced in formulation development, Dr. Reddy’s offers advanced manufacturing facilities across geographies.
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Siegfried AG [9]: A Swiss firm reputed for custom formulations and sterile manufacturing, they could be crucial for RENO-60’s final production.
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Fujifilm Toyama Chemical [10]: With expertise in innovative pharmaceutical formulations, especially in specialized niches, they may serve as potential suppliers.
Regulatory and Supply Chain Considerations
Compliance with international standards—such as the US FDA, EMA, and PMDA—is non-negotiable for RENO-60’s suppliers to ensure market access and patient safety. Many supplier firms have certifications that attest to GMP adherence, quality assurance systems, and Track and Trace capabilities, vital for the traceability of APIs and finished formulations.
Supply chain resilience is equally critical; geographic diversification of suppliers reduces risks linked to geopolitical instability, natural disasters, or pandemics. Asia, Europe, and North America represent key hubs for pharmaceutical manufacturing, with China and India dominating API production due to cost efficiencies and scale.
Emerging Suppliers and Strategic Partnerships
Given the proprietary nature of RENO-60, some companies might pursue strategic alliances with its developer to establish exclusive supply agreements, licensing, or co-manufacturing arrangements. Emerging suppliers in regions such as Southeast Asia or Eastern Europe could provide competitive advantages via cost, proximity, or regulatory flexibility.
Conclusion: Navigating the Supplier Landscape
The supply chain for RENO-60 hinges on multiple tiers of manufacturing, from raw API production to final formulation. Established players like Hikma, Serum Institute, Lonza, and Boehringer Ingelheim stand out as primary candidates due to their proven track records in quality and regulatory compliance. Parallel engagement with regional or emerging suppliers may innovate cost and supply security. Transparency, GMP certification, and strategic partnerships remain core criteria in selecting suppliers for this novel pharmaceutical.
Key Takeaways
- Ensuring a diversified supplier base reduces risks associated with geopolitical, manufacturing, and supply disruptions.
- Leading API manufacturers such as Hikma, Serum Institute, and Cambrex are prime options for sourcing RENO-60’s active ingredient.
- Contract manufacturing organizations like Lonza and Wuxi Stomics offer scalable solutions for API synthesis and formulation.
- Regulatory compliance and GMP standards are critical benchmarks to assess supplier credibility.
- Collaborative licensing agreements can foster exclusive supply arrangements, enhancing supply security and market control.
FAQs
1. What are the primary factors influencing supplier selection for RENO-60?
Regulatory compliance, GMP certification, manufacturing capacity, geopolitical stability, cost competitiveness, and supply chain resilience.
2. How does regional diversification benefit the supply chain of RENO-60?
It mitigates risks associated with regional disruptions, ensures continuous supply, and can optimize costs through regional manufacturing efficiencies.
3. Are there exclusive licensing opportunities for RENO-60 suppliers?
Yes. Strategic partnerships and licensing agreements with the developer can secure exclusivity, enhance supply control, and potentially generate licensing revenues.
4. What certifications should suppliers of RENO-60 possess?
Good Manufacturing Practice (GMP), ISO standards, and regulatory approvals from authorities such as the FDA or EMA.
5. How might emerging suppliers influence the market for RENO-60?
They can introduce cost efficiencies, regional benefits, and innovation, though they must meet stringent quality and regulatory standards.
References
[1] Hikma Pharmaceuticals. (2022). Corporate overview.
[2] Serum Institute of India. (2022). API manufacturing capabilities.
[3] Cambrex Corporation. (2022). API and advanced drug substance manufacturing.
[4] Cipla Limited. (2022). API portfolio and manufacturing plants.
[5] Lonza Group. (2022). Contract manufacturing services.
[6] Wuxi Stomics Bioscience. (2022). API production facilities.
[7] Boehringer Ingelheim. (2022). Innovation in pharmaceutical API manufacturing.
[8] Dr. Reddy’s Laboratories. (2022). Formulation and manufacturing facilities.
[9] Siegfried AG. (2022). Specialization in innovative formulations and sterile products.
[10] Fujifilm Toyama Chemical. (2022). Advanced drug formulation capabilities.
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