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Suppliers and packagers for generic pharmaceutical drug: ziconotide acetate
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ziconotide acetate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060 | NDA | TerSera Therapeutics LLC | 70720-720-10 | 1 VIAL, GLASS in 1 CARTON (70720-720-10) / 1 mL in 1 VIAL, GLASS | 2018-10-15 |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060 | NDA | TerSera Therapeutics LLC | 70720-722-10 | 1 VIAL, GLASS in 1 CARTON (70720-722-10) / 5 mL in 1 VIAL, GLASS | 2018-10-15 |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060 | NDA | TerSera Therapeutics LLC | 70720-723-10 | 1 VIAL, GLASS in 1 CARTON (70720-723-10) / 20 mL in 1 VIAL, GLASS | 2018-10-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ziconotide Acetate
Introduction
Ziconotide acetate, marketed under the brand name Prialt, is a potent synthetic analgesic used primarily for severe chronic pain management, particularly in cases where other treatments have failed. As a synthetic peptide derived from the venom of the marine cone snail Conus magus, ziconotide acetate’s manufacturing process is complex, involving specialized chemical synthesis and purification steps. This article provides a detailed overview of the key suppliers involved in the production, formulation, and distribution of ziconotide acetate, highlighting the landscape's consolidation, geographic distribution, and supplier capabilities.
Manufacturers and Raw Material Suppliers
1. Core Synthetic Producer: International Pharmaceutical Companies
The manufacturing of ziconotide acetate involves sophisticated peptide synthesis techniques, predominantly carried out by specialized pharmaceutical companies with expertise in peptide therapeutics.
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Mersana Therapeutics
A notable player in peptide-based therapeutics, Mersana has capabilities to synthesize complex peptides at a commercial scale, although their focus remains broad across various peptide drugs. -
Fujifilm Toyama Chemical Co., Ltd.
Fujifilm has invested heavily in peptide manufacturing, offering customized synthesis services for complex peptides, including ziconotide. Their advanced manufacturing facilities are certified for pharmaceutical-grade production, making them a key supplier. -
Bachem AG
Based in Switzerland, Bachem is a leading manufacturer of peptides and specialty chemicals. They provide contract manufacturing services, including solid-phase peptide synthesis, suitable for producing ziconotide at industrial scales.
2. Raw Material Suppliers for Peptide Synthesis
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Sigma-Aldrich (Merck Group)
A global leader in chemical and biochemical production, Sigma-Aldrich supplies high-purity amino acids, peptide synthesizers, and reagents essential for ziconotide synthesis. -
GL Biochem (Sinofi)
This Chinese biopharmaceutical-grade peptide raw material provider supplies high-quality amino acids, peptide fragments, and synthesis reagents, which are critical for ziconotide’s manufacturing chain. -
JPT Peptide Technologies
Specialized in the synthesis of custom peptides, JPT offers amino acids, modified peptides, and synthesis services that support ziconotide’s complex manufacturing requirements.
Formulation and Final Product Manufacturing
1. Contract Manufacturers and Formulators
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Alkermes
A global biotech and pharmaceutical contract manufacturer specializing in complex biologics and peptide-based products. Alkermes offers sterile formulation, fill-finish, and packaging services, making them a key supplier for ziconotide acetate finished products. -
Baxter BioPharma Solutions
Baxter provides aseptic processing, formulation, and sterile filling, supporting ziconotide’s delivery via intrathecal infusion methods. -
South Korea’s Daewoong Pharmaceutical
Recently, Daewoong has engaged in the formulation and distribution of peptide therapeutics, including specialty drugs like ziconotide, especially within Asian markets.
Distribution and Commercial Suppliers
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Johnson & Johnson (Janssen)
Janssen is the current commercial producer and marketer of Prialt, the branded form of ziconotide. They oversee global distribution, supply chain logistics, and regulatory compliance. -
Teva Pharmaceutical Industries
Teva has established agreements with Janssen for the distribution of Prialt in various markets and also supplies generic formulations, where available. -
Commercial Distributors and Wholesalers
Major pharmaceutical distribution networks, including McKesson and Cardinal Health, stock Prialt for hospital and specialized pain management clinics.
Specialized Contract Manufacturing Organizations (CMOs)
Agencies with expertise in peptide synthesis and sterile processing play vital roles in bridging the gap between raw material suppliers and end-market products.
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Lonza
Offering peptide synthesis, process development, and GMP manufacturing, Lonza supports scaled production of complex peptides like ziconotide. -
Polypeptide Group
A UK-based CMO offering custom peptide synthesis, purification, and formulation services that can be tailored for ziconotide's production needs.
Supply Chain Dynamics and Market Trends
The supply chain for ziconotide acetate is characterized by high specialization, limited number of key suppliers, and a reliance on advanced peptide synthesis technology. These factors contribute to a relatively concentrated supply network, with a few dominant players controlling the manufacturing.
The ongoing global demand for opioid-sparing analgesics and the growing integration of peptide therapeutics into pain management protocols are expected to sustain and expand the supply chain. Additionally, recent efforts to develop biosimilar versions could alter the competitive landscape.
Regulatory and Quality Considerations
All suppliers involved in the production of ziconotide acetate must adhere to stringent guidelines by agencies such as the FDA, EMA, and PMDA. Good Manufacturing Practice (GMP) compliance is mandatory, ensuring product consistency, safety, and efficacy.
Importantly, peptide synthesis suppliers like Bachem and JPT maintain high-quality standards, providing certificates of analysis (CoA) and batch traceability, which are critical during regulatory approvals.
Conclusion
The supply chain for ziconotide acetate is highly specialized and consolidated among a few key players specialized in peptide synthesis, formulation, and sterile manufacturing. Leading pharmaceutical and biotech companies such as Fujifilm, Bachem, and Lonza dominate the manufacturing landscape, with original distribution managed by Janssen Pharmaceuticals. The technological complexity and regulatory rigor involved in producing this peptide therapeutic underscore the importance of quality and innovation in ensuring a reliable supply for patients suffering from severe chronic pain.
Key Takeaways
- The manufacturing of ziconotide acetate relies on specialized peptide synthesis and sterile formulation, involving a limited number of high-capability suppliers.
- Top suppliers include Fujifilm, Bachem, Lonza, and contract manufacturers like Alkermes, all adhering strictly to GMP standards.
- Raw material suppliers such as Sigma-Aldrich are critical in providing high-purity amino acids and synthesis reagents.
- Distribution is primarily managed by Janssen and partnered pharmaceutical companies, with wholesalers facilitating access to hospitals and clinics.
- Market dynamics suggest continued demand driven by pain management innovations and regulatory support for peptide therapeutics.
Frequently Asked Questions
Q1: What are the main challenges in sourcing ziconotide acetate?
A1: Major challenges include the complexity of peptide synthesis, high manufacturing costs, and regulatory requirements that limit the number of capable suppliers.
Q2: Are there generic or biosimilar versions of ziconotide available?
A2: Currently, ziconotide is primarily marketed by Janssen as Prialt. The development of biosimilars faces technical and patent hurdles due to the peptide’s complexity and proprietary synthesis processes.
Q3: How does the supply chain impact drug pricing and availability?
A3: The specialized manufacturing process and limited supplier base contribute to high costs, affecting accessibility. Supply disruptions could lead to shortages given the niche market.
Q4: What regulations govern the manufacturing of ziconotide acetate?
A4: Strict compliance with GMP standards imposed by agencies like the FDA and EMA is required, emphasizing quality, purity, and stability of the final product.
Q5: How might future innovations influence the supply chain?
A5: Advances in peptide synthesis technology and scalable manufacturing processes could reduce costs, expand supplier options, and improve supply stability.
References
[1] European Medicines Agency. Prialt (ziconotide) Summary of Product Characteristics.
[2] U.S. Food and Drug Administration. Prialt (ziconotide) Prescribing Information.
[3] Bachem. Peptide Manufacturing Capabilities.
[4] Fujifilm. Peptide Synthesis and Contract Manufacturing Services.
[5] Lonza. Peptide and Biologics Manufacturing Solutions.
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