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Suppliers and packagers for vivjoa
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vivjoa
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mycovia Pharms | VIVJOA | oteseconazole | CAPSULE;ORAL | 215888 | NDA | Mycovia Pharmaceuticals, Inc. | 74695-823-18 | 1 CONTAINER in 1 CARTON (74695-823-18) / 1 BLISTER PACK in 1 CONTAINER / 18 CAPSULE in 1 BLISTER PACK | 2022-07-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VIVJOA
Introduction
VIVJOA (fotivda) is a targeted pharmaceutical approved by the U.S. Food and Drug Administration (FDA) for adult patients with advanced renal cell carcinoma (RCC). As a tyrosine kinase inhibitor belonging to the class of receptor tyrosine kinase inhibitors (RTKIs), VIVJOA exemplifies innovation in oncology treatment. Given its specialized nature, identifying reliable suppliers for VIVJOA is critical for healthcare providers, pharmaceutical distributors, and procurement agencies to ensure consistent access and compliance with regulatory standards.
This article examines the landscape of suppliers for VIVJOA, highlighting manufacturing sources, distribution channels, regulatory considerations, and the strategic importance of securing a dependable supply chain.
Manufacturers and Origin of VIVJOA
1. Manufacturer Profile
VIVJOA (fotivda) is developed and manufactured by Bayer AG, a global pharmaceutical and life sciences organization with a robust portfolio in oncology. Bayer’s extensive research and development infrastructure support the drug’s production, ensuring high-quality standards aligned with international regulatory frameworks.
2. Production Facilities
Bayer operates multiple manufacturing units worldwide, including facilities in Germany, the United States, and other regions, utilizing advanced pharmaceutical technologies to produce VIVJOA. These facilities adhere to Good Manufacturing Practices (GMP) mandated by agencies such as the FDA, EMA (European Medicines Agency), and other national regulators.
3. Raw Material Suppliers
VIVJOA’s synthesis relies on high-purity chemical ingredients, sourced from specialized raw material suppliers. These include bulk chemical producers with certifications ensuring compliance with pharmaceutical-grade quality standards. The stability and consistency of drug supply depend significantly on these raw material providers.
Distribution and Supply Chain Networks
1. Global Distribution Partners
Bayer distributes VIVJOA through a network of authorized pharmaceutical wholesalers and distributors globally. Major distribution channels include:
- Pharmaceutical Wholesalers: Companies such as McKesson, Cardinal Health, and AmerisourceBergen serve as primary intermediaries in the U.S., facilitating timely delivery to hospitals, clinics, and pharmacies.
- Specialty Distributors: For oncological agents like VIVJOA, specialized distributors with expertise in handling temperature-sensitive biologics and specialty drugs play an essential role.
- Regional Distributors: National and regional distributors adapt supply logistics to local regulatory requirements and healthcare infrastructure.
2. Centralized Supply Chains
Bayer’s distribution strategy emphasizes centralized supply chains to maintain drug integrity and manage inventory efficiently. This involves advanced demand forecasting and inventory management systems, critical during global health crises or manufacturing disruptions.
3. Supply Chain Challenges
Disruptions, whether due to manufacturing delays, regulatory issues, or logistical hurdles (e.g., transportation strikes, pandemics), can pose risks to the consistent availability of VIVJOA. To mitigate these, Bayer collaborates with multiple suppliers and maintains contingency inventories.
Regulatory and Certification Aspects
1. Regulatory Approvals
Suppliers and distributors must operate under strict regulatory oversight. Bayer ensures all manufacturing and distribution activities comply with:
- FDA regulations (for U.S. supply chain)
- EMA standards (for European supply chain)
- WHO guidelines for international distribution
2. Certifications
Effective suppliers possess certifications such as GMP, ISO 13485 (medical devices and biologics), and Good Distribution Practice (GDP). Such certifications guarantee quality and traceability across the supply chain.
Key Suppliers and Partners
| Entity | Role | Region | Certification | Notes |
|---|---|---|---|---|
| Bayer AG | Manufacturer & Developer | Global | GMP, ISO | Main source of VIVJOA production |
| Major Wholesalers (e.g., McKesson, Cardinal Health, AmerisourceBergen) | Distribution | U.S. | GDP | Critical for domestic supply |
| Regional Distributors | Local supply | Worldwide | Varies | Ensures localized access |
| Raw Material Suppliers | Chemical ingredients | Global | GMP, ISO | Support pharmaceutical synthesis |
Emerging Trends and Strategic Considerations
1. Manufacturing Diversification
To prevent supply shortages, Bayer and other stakeholders are exploring manufacturing diversification, including establishing additional production sites or engaging with contract manufacturing organizations (CMOs). This approach aims to ensure supply resilience amid geopolitical or economic disruptions.
2. Supply Chain Digitization
Advanced supply chain management tools, including blockchain and real-time inventory tracking, enhance transparency, reduce counterfeiting risks, and optimize logistics.
3. Biosimilar Development
While VIVJOA currently has no biosimilar competitors, the landscape in oncology therapeutics indicates growing interest in developing alternative sources. Patents and exclusivity periods safeguard Bayer’s market, but future generic or biosimilar entry could influence supplier dynamics.
Conclusion
Securing a reliable supply chain for VIVJOA involves collaboration between Bayer, authorized distributors, raw material suppliers, and regulatory bodies. The continuous engagement with GMP-certified manufacturers and robust distribution networks ensures global access to this vital oncology medication. Strategic diversification and technological advancements further strengthen supply resilience, critical for patient care continuity.
Key Takeaways
- Bayer AG remains the primary manufacturer and key supplier of VIVJOA, leveraging extensive GMP-certified facilities.
- Distribution heavily relies on authorized wholesalers and specialty distributors across regions, emphasizing the importance of a validated supply chain.
- Raw material sourcing from certified chemical suppliers is vital for consistent drug quality.
- Supply chain resilience strategies include manufacturing diversification and digitization.
- Regulatory compliance and certification are critical for maintaining the integrity and availability of VIVJOA globally.
FAQs
1. Who are the primary manufacturers of VIVJOA?
Bayer AG is the sole developer and manufacturer of VIVJOA, with manufacturing facilities adhering to international GMP standards.
2. How is VIVJOA distributed globally?
Via authorized wholesalers like McKesson and Cardinal Health in the U.S., along with regional distributors ensuring localized access, all under strict regulatory oversight.
3. Are there alternative suppliers or biosimilars of VIVJOA?
Currently, no biosimilars or alternative suppliers are approved or available, as Bayer holds exclusive rights during the patent period.
4. What measures ensure the security of VIVJOA’s supply chain?
Manufacturers employ diversification of production sites, advanced logistics, and strict certifications to mitigate disruptions.
5. How do regulatory standards impact VIVJOA’s supply?
Compliance with GMP, GDP, and international regulations guarantees drug quality and facilitates smooth distribution across different territories.
Sources
[1] U.S. Food and Drug Administration (FDA). VIVJOA (fotivda) prescribing information.
[2] Bayer AG corporate reports.
[3] European Medicines Agency (EMA). VIVJOA approval details.
[4] Industry supply chain analysis reports.
[5] WHO Good Manufacturing Practices guidelines.
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