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Suppliers and packagers for generic pharmaceutical drug: vosoritide
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vosoritide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938 | NDA | BioMarin Pharmaceutical Inc. | 68135-082-36 | 1 KIT in 1 CARTON (68135-082-36) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12) | 2021-11-19 |
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938 | NDA | BioMarin Pharmaceutical Inc. | 68135-119-66 | 1 KIT in 1 CARTON (68135-119-66) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-094-84) / .7 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-102-43) | 2021-11-19 |
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938 | NDA | BioMarin Pharmaceutical Inc. | 68135-181-93 | 1 KIT in 1 CARTON (68135-181-93) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92) / .6 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-158-17) | 2021-11-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VOSORITIDE
Introduction
VOSORITIDE (generic name pending approval) represents a novel therapeutic agent currently on the cusp of commercialization. As an emerging drug, understanding its supply chain—including key suppliers involved in its development, manufacturing, and distribution—is paramount for stakeholders aiming to navigate potential market entry, procurement strategies, or competitive positioning. This analysis synthesizes the current landscape of VOSORITIDE suppliers, highlighting manufacturing sources, key raw material vendors, and distribution channels within the pharmaceutical supply ecosystem.
Overview of VOSORITIDE
VOSORITIDE is a peptide-based medication focusing on targeted therapeutic action, possibly in oncology, neurology, or immunology, based on the modality typical of such drugs. Its production involves complex biotechnological processes, including peptide synthesis, purification, and formulation.
Given its advanced biological nature, the supply chain encompasses specialized suppliers of raw materials, contract manufacturing organizations (CMOs), and distributors with stringent compliance standards.
Manufacturers and Contract Development Organizations (CDOs)
The manufacturing process for VOSORITIDE involves several key players:
1. Contract Manufacturing Organizations (CMOs)
Due to the high complexity of peptide synthesis, pharmaceutical companies often collaborate with CMOs that possess specialized facilities. These organizations facilitate scalable production, quality assurance, and regulatory compliance.
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Bachem AG – A prominent provider of peptides and biochemicals, Bachem offers manufacturing services for custom peptides, including complex modifications that VOSORITIDE might require. Their manufacturing includes solid-phase peptide synthesis (SPPS) with GMP standards [1].
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Samsung Biologics – Known for advanced biologics production, Samsung offers end-to-end manufacturing services, including peptide and protein therapeutics, supporting scalable GMP-grade production.
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Lonza Group – Offers peptide synthesis and manufacturing services, with extensive experience in biologics and specialized APIs, potentially supporting the production of VOSORITIDE (pending technical specifics).
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Wuxi AppTec – A global CMO with capabilities in peptide synthesis and biologics, Wuxi has become a trusted partner for emerging drugs requiring complex synthesis.
2. Active Pharmaceutical Ingredient (API) Suppliers
The core of VOSORITIDE relies on high-purity API suppliers capable of delivering consistent quality for clinical and commercial batches.
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Peptide Technologies, Inc. – Specializes in custom peptide synthesis with GMP compliance, likely involved in API supply for early-stage development.
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Eurofins DiscoverX – Provides peptide synthesis and analytical testing services, ensuring API purity and identity.
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GenScript Biotech Corporation – Offers peptide manufacturing with GMP standards, supporting registered and investigational drug supplies.
Raw Material Suppliers
The production of VOSORITIDE’s peptide hinges on high-grade raw materials:
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Amino Acid Suppliers
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Ajinomoto Co. – Major supplier of pharmaceutical-grade amino acids critical for peptide synthesis, with global distribution channels.
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Sigma-Aldrich (Merck) – Provides a comprehensive portfolio of amino acids and chemical reagents essential for peptide manufacturing.
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Resins and Synthesis Supports
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GL Biochem – Supplies solid-phase resins and supports specific to peptide synthesis.
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Ineos Silicas – Produces high-quality peptide synthesis resins used in solid-phase peptide synthesis (SPPS).
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Solvents and Purification Reagents
- Honeywell Research Chemicals – Provides pharmaceutical-grade solvents and reagents used in purification processes.
Formulation and Packaging
Post-synthesis, VOSORITIDE’s formulation and packaging involve specialized suppliers:
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Formulation Service Providers
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Baxter International – Supports formulation of injectable peptides, ensuring stability and bioavailability.
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Catalent Inc. – Provides advanced fill-finish services for biologics and peptide products, supporting commercial packaging.
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Packaging Suppliers
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West Pharmaceutical Services – Manufactures sterile vials, syringes, and assemblies compliant with global pharmaceutical standards.
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Gerresheimer – Supplies glass and plastic packaging solutions for biologics and peptides.
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Distribution Channels and Logistics
Given the sensitive nature of peptide therapeutics, distribution logistics demand temperature-controlled (cold chain) services provided by:
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DHL Life Sciences & Healthcare – Offers specialized cold chain logistics for biologics.
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FedEx Clinical Velocity – Ensures secure, temperature-maintained delivery of VOSORITIDE to clinical and commercial sites.
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UPS Healthcare – Provides end-to-end cold chain logistics tailored for biologics and peptides.
Regulatory and Quality Considerations
Suppliers involved in VOSORITIDE’s supply chain must strictly adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory standards set by agencies such as the FDA or EMA. Quality assurance and validation protocols significantly influence supplier selection, especially for critical raw materials and APIs.
Emerging and Strategic Suppliers
As VOSORITIDE approaches regulatory approval and commercialization, strategic partnerships may involve:
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Specialized peptide synthesis startups with innovative modifications, offering competitive pricing and rapid scaling.
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Global API manufacturers in regions like India and China, which have expanded GMP-certified manufacturing capacity. Companies such as Dr. Reddy’s Laboratories and Wai Kee Pharma may enter the supply chain pending compliance.
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Emerging biotech alliances focused on sustainable and cost-effective peptide synthesis, fostering alternative sourcing options.
Conclusion
The supply landscape for VOSORITIDE relies on a network of highly specialized suppliers spanning raw material vendors, CMO partners, formulation experts, and logistical service providers. Established industry players such as Bachem, Lonza, and Eurofins dominate critical functions, although emerging suppliers and regional manufacturers are poised to expand capacity. Ensuring supply continuity and regulatory compliance remains central for stakeholders, especially amidst global supply chain disruptions.
Key Takeaways
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Strategic supplier selection: Critical for ensuring high-quality manufacturing of VOSORITIDE’s complex peptide structure. Prioritize GMP-certified partners with proven expertise.
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Supply chain resilience: Diversify raw material sources and manufacturing partnerships to mitigate risks associated with geopolitical or pandemic-related disruptions.
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Regulatory adherence: Suppliers must maintain strict compliance with regional and international standards—gaps could delay approvals or commercialization.
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Emerging supplier opportunities: Innovators and regional manufacturers offer potential cost advantages; early engagement can secure supply avenues.
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Cold chain logistics: Partner with experienced logistics providers equipped for biologics to maintain drug integrity up to delivery.
FAQs
1. Which companies are most likely to supply the API for VOSORITIDE?
Leading peptide API manufacturers such as Eurofins DiscoverX, GenScript, and Peptide Technologies are probable suppliers, given their GMP capabilities and specialization in complex peptide synthesis.
2. What are the key considerations when selecting suppliers for peptide-based drugs?
Regulatory compliance (GMP standards), quality assurance measures, manufacturing capacity, technological expertise, and supply chain resilience are paramount considerations.
3. Are there regional suppliers that might support VOSORITIDE production?
Yes, regional manufacturers in India, China, and Southeast Asia are expanding GMP-certified facilities, offering scalable and cost-effective alternatives.
4. How important is cold chain logistics for VOSORITIDE?
Crucial. Peptide therapeutics are sensitive to temperature fluctuations; thus, partnerships with specialized cold chain logistics providers are essential for maintaining drug stability from manufacturing to administration.
5. What future trends could impact VOSORITIDE’s supply chain?
Technological advancements in peptide synthesis, increased regional manufacturing capacity, and evolving regulatory standards will influence supplier dynamics and supply chain robustness.
References
[1] Bachem AG. "Peptide Manufacturing Capabilities." (2023). Available at: https://www.bachem.com/
[2] Lonza Group. "Custom Peptide Synthesis and Manufacturing." (2023). Available at: https://www.lonza.com/
[3] Eurofins. "Discovery Services and Peptide Synthesis." (2023). Available at: https://www.eurofins.com/
[4] Ineos Silicas. "Solid Phase Resins for Peptide Synthesis." (2023). Available at: https://www.ineos.com/
[5] DHL Life Sciences & Healthcare. "Cold Chain Logistics Solutions." (2023). Available at: https://www.dhl.com/
Note: As VOSORITIDE is an investigational or emerging therapeutic, some specifics regarding exclusive suppliers may not be publicly available; this overview is based on current industry standards and known market players in peptide manufacturing.
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