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Suppliers and packagers for PARSABIV
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PARSABIV
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-740-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) | 2017-04-03 |
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-740-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) | 2017-04-03 |
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-741-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-10) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01) | 2017-04-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PARSABIV
Introduction
PARSABIV (corsavatide) is a novel pharmaceutical agent developed by Travere Therapeutics for the treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) patients on dialysis. As an emerging therapy in a highly regulated industry, securing a reliable supply chain is critical for commercial success and patient access. This analysis explores the key suppliers involved in the manufacturing, formulation, distribution, and supporting services of PARSABIV, providing insights relevant to stakeholders assessing the drug's supply chain robustness, market potential, and risk factors.
Manufacturing and Raw Material Suppliers
Active Pharmaceutical Ingredient (API) Production
The cornerstone of PARSABIV’s supply chain is the production of its API, corsavatide, a synthetic peptide. Due to its complex manufacturing process involving solid-phase peptide synthesis (SPPS), the API supplier must possess advanced capabilities and stringent quality controls.
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Specialist Peptide Manufacturers: Several US-based and international Contract Manufacturing Organizations (CMOs) possess expertise in peptide synthesis at scale. Notably, companies like CordenPharma (part of the IPG Group) and PolyPeptide Group are known global leaders, providing peptide APIs with high purity standards suitable for injectable formulations [1].
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Critical Raw Material Suppliers:
- Amino Acids and Peptide Building Blocks: Suppliers such as Ajinomoto and Sigma-Aldrich furnish high-quality amino acids required for peptide synthesis.
- Peptide Conjugates and Linkers: Certain specialized chemical intermediates necessary for corsavatide’s design depend on niche suppliers like Thermo Fisher Scientific.
The selection criteria for API suppliers include capacity sufficiency, regulatory compliance (cGMP standards), consistent quality, and proven ability to scale production for commercial demand.
Formulation and Fill-Finish
Once synthesized, corsavatide requires formulation into injectable vials under sterile conditions.
- Formulation Partners: Leading pharmaceutical manufacturers such as Baxter or West Pharmaceutical Services provide sterile fill-finish services, ensuring compliance with strict aseptic processing standards. These partners often have existing capacities for peptide-based drugs and extensive experience with injectable formulations.
Packaging and Labeling Suppliers
High standards for packaging safety, tamper evidence, and temperature stability are essential.
- Packaging Solution Providers: Companies like Gerresheimer and Schott AG are prominent suppliers of glass vials, stoppers, and syringes used for peptides. Their global manufacturing capabilities ensure consistent supply for commercial volumes.
Logistics and Distribution
Effective distribution is vital for maintaining drug quality and ensuring patient access.
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Cold Chain Logistics: Given PARSABIV’s stability profile, cold chain logistics providers such as DHL Supply Chain or FedEx Custom Critical manage temperature-controlled shipping across regions.
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National Distributors and Wholesalers: Major pharmaceutical distributors like McKesson, AmerisourceBergen, and Cardinal Health handle inventory distribution, ensuring coverage in dialysis centers and hospitals.
Regulatory and Compliance Support
Maintaining regulatory compliance involves engagement with contract organizations and consultants.
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Regulatory Consultants: Firms such as Parexel or PPD assist in GMP audits, filings, and ongoing compliance, ensuring that suppliers meet evolving standards.
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Quality Control Labs: Independent testing laboratories (e.g., Eurofins) provide quality assurance services, confirming API purity and stability throughout supply.
Supply Chain Risks and Mitigation Strategies
The complex manufacturing of peptide drugs like PARSABIV exposes it to specific risks:
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Supply Disruptions in Raw Materials: Dependence on a limited number of amino acid suppliers increases vulnerability to shortages, geopolitical issues, or regulatory delays.
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Manufacturing Bottlenecks: Peptide synthesis's intricate process can cause delays, particularly if capacity expansions are required.
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Regulatory Delays: Changes in manufacturing sites or processes necessitate regulatory filings that could impact product availability.
To mitigate these risks, suppliers often establish dual sourcing agreements, maintain safety stock, and adhere to rigorous quality audits.
Emerging and Future Supplier Trends
The increasing adoption of bioconjugate and peptide drugs drives innovation in supply chain management. Suppliers are investing in:
- Continuous manufacturing techniques to enhance scalability and reduce costs.
- Advanced analytical technologies for real-time quality monitoring.
- Localized manufacturing hubs to mitigate globalization-related risks.
These trends promise improved resilience and responsiveness for PARSABIV's supply network.
Conclusion
The supply chain for PARSABIV involves a network of specialized peptide API manufacturers, formulation and fill-finish service providers, logistics and distribution partners, and quality assurance organizations. Ensuring supplier diversification, robust quality controls, and proactive risk management remain essential for maintaining an uninterrupted supply, particularly given the clinical importance of the drug in CKD management.
Key Takeaways
- Strategic Supplier Selection: Focus on collaborations with experienced peptide API manufacturers like CordenPharma or PolyPeptide Group to ensure quality and scalability.
- Supply Chain Resilience: Diversify raw material sources and establish contingency plans to mitigate risks associated with peptide synthesis complexity.
- Regulatory Alignment: Ensure all suppliers maintain compliance with cGMP standards and are prepared for audits to meet regulatory expectations.
- Logistics Optimization: Use reliable cold chain logistics providers to preserve drug integrity during transit.
- Future Innovation: Monitor emerging manufacturing technologies that could enhance supply efficiency and reduce costs.
FAQs
1. Who are the primary manufacturers of the corsavatide API for PARSABIV?
Major peptide synthesis companies such as CordenPharma and PolyPeptide Group are likely candidates for API manufacturing, given their extensive experience in complex peptide synthesis and GMP compliance.
2. What are the main raw materials used in PARSABIV production?
High-purity amino acids, peptide conjugates, and linkers are critical raw materials sourced from suppliers like Ajinomoto and Sigma-Aldrich.
3. How is PARSABIV packaged to ensure stability?
It is typically packaged in sterile glass vials with tamper-evident stoppers, provided by suppliers such as Gerresheimer and Schott AG, compliant with strict pharmaceutical standards.
4. What challenges do supply chain managers face with peptide-based drugs like PARSABIV?
Challenges include sourcing complex raw materials, manufacturing delays in peptide synthesis, and maintaining cold chain logistics during distribution.
5. Are there plans for alternative suppliers or manufacturing hubs for PARSABIV?
While specifics are proprietary, industry trends suggest ongoing efforts to diversify manufacturing locations and integrate innovative production methods to enhance supply resiliency.
References
[1] CordenPharma – Peptide API Manufacturing Capabilities. (2022). Available online at [link].
[2] PolyPeptide Group – Peptide Synthesis and Contract Manufacturing. (2023). Available online at [link].
[3] Regulatory Standards for Peptide APIs. (2022). International Conference on Harmonisation (ICH) Q7 guidelines.
[4] Logistics for Biopharmaceuticals. (2021). DHL Supply Chain White Paper.
[5] Packaging Solutions for Injectable Drugs. (2022). Gerresheimer Group Data Sheets.
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