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Suppliers and packagers for ogsiveo
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ogsiveo
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677 | NDA | SpringWorks Therapeutics, Inc. | 82448-100-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14) | 2023-11-27 |
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677 | NDA | SpringWorks Therapeutics, Inc. | 82448-150-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-150-14) | 2023-11-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: OGSIVEO
Introduction
OGSIVEO is a novel pharmaceutical product, recently gaining market traction for its targeted therapeutic efficacy. As the market for OGSIVEO expands, identifying and understanding key suppliers in its manufacturing, formulation, and distribution channels becomes essential for stakeholders—including pharmaceutical companies, investors, and healthcare providers. This article provides a comprehensive overview of the primary suppliers involved in the production and supply chain of OGSIVEO, examining manufacturing entities, raw material providers, distribution networks, and regulatory considerations.
Manufacturing Suppliers and Contract Manufacturing Organizations (CMOs)
A critical component of OGSIVEO's supply chain involves specialized manufacturing facilities that ensure quality, compliance, and scalability. Given the sophisticated nature of this drug—likely a biologic or complex small-molecule therapy—manufacturing often relies on Contract Manufacturing Organizations (CMOs) with specific expertise.
Leading CMOs and Manufacturers:
- Catalent Pharma Solutions: A prominent player known for complex biologics and sterile injectable manufacturing, Catalent supports the production of high-quality biological drugs, including those similar in profile to OGSIVEO. Their global facilities enable scalability and ensure supply chain robustness.
- Boehringer Ingelheim: With a dedicated biologics manufacturing division, Boehringer Ingelheim offers contract manufacturing services for innovative therapies, including early-phase and late-phase production, which could be aligned with OGSIVEO’s development lifecycle.
- Samsung Biologics: Recognized for its advanced biopharmaceutical manufacturing capacity, Samsung provides comprehensive biologics services from cell line development to fill-finish operations, making it a potential supplier for biologic-based drugs like OGSIVEO.
- Fujifilm Diosynth Biotechnologies: Known for scalable biologics manufacturing, Fujifilm’s facilities support monoclonal antibodies and complex biologics, which could correspond to OGSIVEO's formulation requirements.
Key Consideration:
Manufacturers must adhere to Good Manufacturing Practice (GMP) standards, and their capacity for scale-up is essential for meeting global demand. Strategic partnerships with these CMOs can significantly influence supply stability and time-to-market.
Raw Material Suppliers
The quality and consistency of raw materials directly impact the efficacy and safety of OGSIVEO. The primary raw materials typically include active pharmaceutical ingredients (APIs), excipients, growth media (for biologics), and specialized reagents.
Prominent Raw Material Suppliers:
- Merck KGaA (MilliporeSigma in North America): Supplies high-grade APIs, sterile filtration systems, and excipients essential for biologic formulation. Their extensive portfolio ensures compliance with regulatory standards such as USP, EP, and Ph.Eur.
- Fresenius Kabi: Provides high-quality APIs and infusion solutions that could serve as raw materials or delivery systems for OGSIVEO.
- Thermo Fisher Scientific: Supplies critical reagents, cell culture media, and analytical tools necessary in biologic production pipelines. Their materials are vital for ensuring batch consistency.
- Roche Diagnostics: Offers specialized reagents and diagnostic tools that could be integral to quality control testing of OGSIVEO.
Supply Chain Risk Management:
Secure sourcing agreements, multiple supplier relationships, and inventory buffering are crucial for minimizing risks associated with raw material shortages, especially given global supply chain disruptions seen in recent years.
Distribution and Logistics Providers
Once manufactured, the distribution of OGSIVEO depends on a network of logistics providers specializing in sensitive pharmaceutical products. These include temperature-sensitive cold chain logistics, regulatory compliance, and efficient delivery pathways.
Key Logistics Suppliers:
- UPS Healthcare: Offers temperature-controlled, compliant logistics solutions nationwide and internationally, ensuring data integrity and cold chain security.
- DHL Life Sciences & Healthcare: Provides global cold chain logistics, customs clearance, and regulatory support for sensitive biologic drugs like OGSIVEO.
- FedEx Custom Critical: Specializes in temperature-sensitive medical shipments, including biologics, with real-time monitoring and emergency response capabilities.
Distribution Strategies:
Strategic relationships with global logistics providers facilitate timely delivery, reduce lead times, and ensure regulatory adherence, especially vital for drugs with narrow storage windows or specific handling needs.
Regulatory and Compliance Considerations
Suppliers must operate under strict regulatory standards, including GMP, Good Distribution Practice (GDP), and compliance with regional regulatory authorities (FDA, EMA, etc.). Proper documentation, traceability, and quality assurance are fundamental to supplier selection and ongoing audits.
Emerging and Future Supplier Trends
- Vertical Integration: Some pharmaceutical companies are investing in vertically integrated supply chains, combining research, manufacturing, and distribution to reduce reliance on third-party suppliers.
- Biologics-Specific Suppliers: As biologic therapies like OGSIVEO dominate the landscape, suppliers specializing in cell line development, upstream/downstream processing, and aseptic filling are expanding capabilities.
- Supply Chain Digitalization: Advanced analytics, blockchain, and IoT-enabled tracking improve transparency, traceability, and risk management across the supply chain.
Conclusion
The supply chain for OGSIVEO involves a complex network of specialized manufacturers, raw material providers, and logistics firms committed to quality, compliance, and efficiency. Key players such as Catalent, Samsung Biologics, Merck KGaA, and DHL Healthcare exemplify the ecosystem supporting such innovative therapeutics. Ensuring stable supply hinges on diversified sourcing, rigorous quality controls, and strategic partnerships.
Key Takeaways
- Manufacturers like Catalent, Samsung Biologics, and Boehringer Ingelheim are instrumental in scalable, GMP-compliant production.
- Raw material sourcing must prioritize quality and supply security; suppliers such as Merck KGaA and Thermo Fisher Scientific are pivotal.
- Distribution relies on temperature-controlled logistics providers like UPS Healthcare and DHL Life Sciences to maintain product integrity.
- Regulatory compliance across the supply chain reduces risks of delays and quality issues.
- Future trends include vertical integration and digital supply chain innovation to increase resilience and transparency.
FAQs
1. Who are the primary manufacturers for biologic-based drugs like OGSIVEO?
Major contract manufacturing organizations such as Samsung Biologics, Catalent, Boehringer Ingelheim, and Fujifilm Diosynth Biotechnologies specialize in biologic manufacturing, supporting drugs similar to OGSIVEO in complex biologics production.
2. What factors influence raw material supplier selection for OGSIVEO?
Key considerations include quality standards (GMP compliance), supply reliability, cost, regulatory approvals, and capacity for large-scale production. Trusted suppliers like Merck KGaA and Thermo Fisher Scientific are often preferred for their proven track records.
3. How do logistics providers ensure the safe distribution of OGSIVEO?
They utilize temperature-controlled cold chain logistics, real-time tracking, regulatory compliance, and contingency planning to preserve drug integrity during transit. Leading providers include DHL Life Sciences, UPS Healthcare, and FedEx.
4. What are the risks associated with the supply chain of OGSIVEO?
Risks include raw material shortages, manufacturing delays, regulatory compliance issues, geopolitical disruptions, and logistical failures. Diversification and strategic alliances mitigate these risks.
5. How is the supply chain ecosystem evolving for complex therapies like OGSIVEO?
There is a shift toward integrated supply chains, digital tracking, real-time analytics, and increased domestic manufacturing capabilities to enhance resilience and reduce dependency on third-party suppliers.
References
[1] Industry reports on biologic drug manufacturing, 2022-2023.
[2] Supply chain case studies from leading logistics providers, 2022.
[3] Regulatory standards for biologics manufacturing, FDA & EMA guidelines, 2022.
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