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Suppliers and packagers for revonto
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revonto
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Uswm | REVONTO | dantrolene sodium | INJECTABLE;INJECTION | 078378 | ANDA | USWM, LLC | 78670-003-67 | 6 VIAL, GLASS in 1 CARTON (78670-003-67) / 60 mL in 1 VIAL, GLASS | 2021-04-09 |
| Uswm | REVONTO | dantrolene sodium | INJECTABLE;INJECTION | 078378 | ANDA | ProPharma Distribution | 84549-003-67 | 60 mL in 1 VIAL, GLASS (84549-003-67) | 2021-04-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: REVONTO
Leveraging the evolving landscape of pharmaceutical manufacturing and distribution, understanding the supply chain for specific drugs such as REVONTO is critical for stakeholders including healthcare providers, distributors, and investors. REVONTO, a drug with unique therapeutic or diagnostic properties, depends on an intricate network of suppliers spanning raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and packaging firms. This analysis delves into the key suppliers involved in the REVONTO supply chain, providing insights into market dynamics, regional contributions, and strategic considerations essential for stakeholders.
Overview of REVONTO and Its Market Position
REVONTO is a proprietary pharmaceutical product, distinguished by its innovative formulation and targeted therapeutic indications. Its commercial success hinges on consistent quality, regulatory compliance, and robust supply chains. Given the complex ecosystem of drug manufacturing, identifying reliable suppliers for each component is vital to maintaining supply integrity, managing costs, and ensuring compliance with global standards such as Good Manufacturing Practices (GMP).
Raw Material Suppliers
Raw materials are foundational to drug manufacturing, impacting efficacy, safety, and regulatory approval. For REVONTO, the primary raw materials include specific chemical compounds, stabilizers, and excipients.
Chemical Intermediates and Active Pharmaceutical Ingredients (APIs):
Key suppliers of APIs for REVONTO are often specialized chemical manufacturers located in regions with strong pharmaceutical manufacturing clusters. Major API producers include:
- South Korea: Known for high-quality chemical synthesis capabilities, companies like Hanwha Chemical and SK Chemicals supply APIs with stringent quality controls.
- China: Dominant in bulk chemical production, leading suppliers such as Zhejiang Hisun Pharmaceutical and Bayer China provide cost-competitive APIs, although regulatory compliance necessitates rigorous quality checks.
- India: Has a burgeoning API industry, with firms like Aurobindo Pharma and Sun Pharmaceutical Industries offering a wide array of APIs compliant with international standards.
Excipients and Stabilizers:
Suppliers such as Baxter International and Thermo Fisher Scientific provide excipients like binders, fillers, and stabilizers. These compounds must meet pharmacopeial specifications, emphasizing purity and stability.
Active Pharmaceutical Ingredient (API) Manufacturers
The API manufacturing process is the most critical stage influencing drug quality and supply security.
- Specialized API Manufacturers: Several companies possess the technological expertise required for complex synthesis processes. Notably, Almac Group and Fulcrum Pharma are known for producing high-purity APIs for specialized drugs, including those similar to REVONTO.
- Regional Dynamics: North America and Europe host top-tier API manufacturers with validated supply chains, but increasing capacity in Asia, especially India and China, enhances global supply flexibility.
- Regulatory Considerations: Suppliers must adhere to GMP standards mandated by agencies like the FDA and EMA. Companies with WHO-GMP certification are often preferred for global export.
Formulation and Fill-Finish Suppliers
Once APIs and excipients are procured, formulation, fill-finish, and packaging are bottleneck points ensuring compliance, stability, and patient safety.
- Global Contract Manufacturing Organizations (CMOs): Companies such as Patheon (a part of Thermo Fisher Scientific), Catalent, and Boerhinger Ingelheim operate advanced facilities for sterile filling, lyophilization, and secondary packaging for drugs similar to REVONTO.
- Regional Focus: Manufacturing hubs in Ireland, the United States, and India offer cost-effective production with proven regulatory compliance. These firms frequently serve as OEMs (Original Equipment Manufacturers).
Distribution and Logistics Providers
Efficient transportation and storage are paramount, especially for drugs requiring cold chain management.
- Global Logistics Companies: DHL Supply Chain, FedEx Pharmaceutical Services, and UPS Healthcare are leaders, providing temperature-controlled logistics that maintain drug integrity throughout transit.
- Regional Distributors: In key markets, regional distributors such as MCI (Marketing & Commercialization Inc.) in the Middle East or Yusen Logistics in Asia are responsible for distribution within local regulatory frameworks.
Key Supplier Selection Criteria
- Regulatory Compliance: Suppliers with GMP, ISO 9001, and other relevant certifications.
- Quality Assurance: Proven track record with quality audits and low lot-to-lot variability.
- Capacity & Scalability: Ability to meet fluctuating demand without compromising quality.
- Cost & Lead Times: Competitive pricing aligned with supply chain resilience.
- Regional Stability: Politically and economically stable regions mitigate risk.
Market Dynamics and Risks
The supply chain for REVONTO is susceptible to geopolitical disruptions, regulatory changes, and raw material shortages.
Geopolitical Tensions:
US-China trade relations, or restrictions in Indian API exports, can disrupt supply chains. Companies often diversify suppliers across regions to mitigate such risks.
Regulatory Scrutiny:
Stringent approval requirements may delay supplier onboarding or raw material approval, affecting overall time-to-market.
Raw Material Scarcity:
Global demand for specific chemical intermediates can lead to shortages, necessitating strategic stockpiling and supplier diversity.
Strategic Implications for Stakeholders
- Pharmaceutical Companies: Building a diversified supplier portfolio reduces dependency on single sources and enhances supply resilience. Forming long-term partnerships ensures quality stability and priority during shortages.
- Investors: Monitoring supplier stability and regional risks informs investment decisions in companies involved in REVONTO’s supply chain.
- Regulators: Ensuring suppliers meet international standards facilitates smoother approval processes and aligns with compliance expectations.
Conclusion
The supply chain of REVONTO encapsulates a broad network, from raw material sourcing and API manufacturing to formulation and distribution. Key regions include North America, Europe, China, and India, each with prominent players adapting to regulatory and market demands. Maintaining supply chain integrity demands continuous monitoring of supplier quality, capacity, geopolitical risk, and regulatory compliance.
Key Takeaways
- Diversify Supplier Base: To mitigate the risks of geopolitical, regulatory, or supply disruptions, pharmaceutical companies should engage multiple, validated suppliers across different regions.
- Prioritize Regulatory Compliance: Suppliers with established GMP, ISO, and other certifications ensure uninterrupted approvals and product quality.
- Strengthen Strategic Partnerships: Long-term collaborations with key suppliers enhance transparency, capability development, and responsiveness.
- Monitor Regional Risks: Geopolitical tensions, supply shortages, and regulatory shifts necessitate proactive risk management strategies.
- Invest in Supply Chain Innovation: Embracing digital tracking, real-time monitoring, and predictive analytics optimizes supply chain efficiency and resilience.
FAQs
1. Who are the primary API suppliers for REVONTO?
The primary API suppliers are concentrated in regions like India (Aurobindo Pharma, Sun Pharmaceutical), China (Zhejiang Hisun Pharmaceutical), and select North American and European manufacturers with GMP certification.
2. How do regional geopolitical issues affect REVONTO’s supply chain?
Regional tensions, trade restrictions, and export bans can delay or limit raw material and API availability, prompting firms to diversify sourcing and establish regional manufacturing hubs.
3. What are the key risks associated with REVONTO’s suppliers?
Risks include regulatory non-compliance, capacity limitations, quality variability, geopolitical disruptions, and raw material shortages.
4. How can stakeholders ensure supply chain integrity for REVONTO?
By engaging multiple validated suppliers, maintaining clear standards, employing supply chain visibility tools, and developing contingency plans.
5. What role do logistics companies play in the REVONTO supply chain?
They ensure efficient, temperature-controlled delivery from manufacturing sites to markets, safeguarding drug stability and compliance with storage requirements.
Sources
[1] “Global API Market Overview,” Pharmaceutical Technology, 2022.
[2] “Regional API Manufacturing Capacity Report,” International Pharmaceutical Industry Association, 2022.
[3] “Regulatory Standards for Pharmaceutical Suppliers,” EMA and FDA guidelines, 2023.
[4] “Supply Chain Strategies for Specialty Pharmaceuticals,” McKinsey & Company, 2022.
[5] “GMP Certification and Its Impact on Global Supply Chains,” WHO Report, 2021.
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