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Suppliers and packagers for generic pharmaceutical drug: VOCLOSPORIN
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VOCLOSPORIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurinia | LUPKYNIS | voclosporin | CAPSULE;ORAL | 213716 | NDA | Aurinia Pharma U.S., Inc. | 75626-001-02 | 3 PACKET in 1 CARTON (75626-001-02) / 4 BLISTER PACK in 1 PACKET (75626-001-01) / 15 CAPSULE in 1 BLISTER PACK | 2021-01-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Voclosporin
Introduction
Voclosporin, a next-generation calcineurin inhibitor, has garnered significant attention in the realm of immunosuppressive therapies, particularly for its potential in treating autoimmune diseases such as lupus nephritis. Initially developed byOptimer Pharmaceuticals and later acquired by Aurinia Pharmaceuticals, voclosporin's manufacturing and supply chain span multiple specialized suppliers. Understanding these suppliers is essential for stakeholders—including healthcare providers, investors, and regulatory bodies—seeking to assess the drug’s market dynamics, supply security, and growth prospects.
Manufacturers and Supply Chain Overview
Origin and Development
Voclosporin, a cyclic peptide belonging to the calcineurin inhibitor class, was developed to provide a more potent, stable, and safer alternative to existing drugs like cyclosporine. Its development was driven by innovations in peptide synthesis and advanced formulation techniques to enhance bioavailability and reduce adverse effects.
The initial production was conducted under the auspices of Dr. Reddy’s Laboratories and ACORN Pharmaceuticals in partnership with the original developers. However, post-2015, production and commercialization efforts shifted primarily to Aurinia Pharmaceuticals, which received FDA approval for LUPKYNIS (brand name for voclosporin) in 2021.
Primary Suppliers and Manufacturing Partners
1. Aurinia Pharmaceuticals (Canada and International)
Aurinia acts as the primary marketer and distributor for voclosporin. As of the latest updates, Aurinia centrally manages the supply chain but relies on external manufacturing partners to produce the active pharmaceutical ingredient (API) and finished drug product. The company's strategic focus includes ensuring manufacturing scalability to meet global demand.
2. API Manufacturers
Given the complex synthesis process of voclosporin, the API is produced by specialized contract manufacturing organizations (CMOs). Major suppliers include:
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Bachem AG (Switzerland): Known for high-quality peptide synthesis, Bachem likely supplies the API or intermediates due to its expertise in peptide-based pharmaceuticals. Their robust infrastructure supports large-scale production.
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Samsung BioLogics (South Korea): As a leading CMO specializing in biologics and complex peptide APIs, Samsung BioLogics possesses the capacity to scale voclosporin production to meet global demand.
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WuXi AppTec (China): A global contract testing and manufacturing organization with extensive peptide synthesis capabilities, WuXi could supply or assist in the production of voclosporin’s API.
3. Formulation and Finished Drug Manufacturers
The finished drug, LUPKYNIS, is produced in facilities compliant with Good Manufacturing Practices (GMP). These facilities are often operated by:
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Aurinia’s in-house manufacturing plants in North America or Europe.
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Contract manufacturing organizations such as BioGen (Turkey) or Almac Group (UK) that provide fill-finish services.
Supply Chain Challenges and Strategies
Given vocal concerns associated with complex peptide synthesis, supply chain resilience depends on diversification of API suppliers and manufacturing sites. Global shortages or disruptions in peptide synthesis have historically affected similar drugs, prompting Aurinia to establish multiple supplier relationships to mitigate risks.
Regulatory Framework and Global Supply Considerations
The manufacturing of voclosporin must comply with stringent regulatory standards, including FDA, EMA, and other health authorities. Aurinia primarily secures approvals for manufacturing facilities through rigorous inspections and quality assurance protocols.
International distribution relies on the approval status in various markets, such as the EMA's authorization in Europe and subsequent approvals in Japan, Australia, and other jurisdictions. This regulatory landscape influences sourcing strategies and supply chain robustness.
Market Dynamics and Future Supply Outlook
The increasing demand for voclosporin, driven by unmet needs in lupus nephritis, is spurring capacity expansions. Aurinia’s strategic collaborations with third-party manufacturers aim to ensure supply meets global demand, especially as approval expands into international markets.
The drug’s patent status and potential biosimilar developments could influence future supplier relationships and manufacturing investments. Aurinia’s proactive approach includes securing multiple manufacturing sites and developing alternate suppliers to preclude supply shortages.
Conclusion
The supply chain for voclosporin involves a combination of specialized peptide API manufacturers—such as Bachem AG, Samsung BioLogics, and WuXi AppTec—and contract fill-finish service providers. Aurinia Pharmaceuticals orchestrates the global distribution, predominantly relying on a diversified network of high-quality manufacturing partners to meet rising demand.
Robust supply chain management, compliance with international regulatory standards, and diversification of manufacturing sources underpin the drug’s availability. Continued investments in manufacturing capacity and supply chain resilience are critical to maintaining steady access to this immunosuppressive agent amid expanding indications and markets.
Key Takeaways
- Primary suppliers for voclosporin’s API include Bachem AG, Samsung BioLogics, and WuXi AppTec, each specializing in peptide synthesis at commercial scale.
- Aurinia Pharmaceuticals orchestrates manufacturing and global distribution, leveraging multiple contract manufacturing organizations.
- Supply chain resilience depends on diversified API sources and manufacturing sites to mitigate risks of shortages or disruptions.
- Regulatory compliance ensures manufacturing facilities meet GMP standards, facilitating international approvals and distribution.
- Market expansion and increased demand necessitate ongoing capacity investments and supplier diversification strategies.
FAQs
1. Who are the main API suppliers for voclosporin?
The primary API suppliers include Bachem AG, Samsung BioLogics, and WuXi AppTec, all specializing in peptide synthesis and contract manufacturing at scale.
2. How does Aurinia Pharmaceuticals ensure a stable supply of voclosporin?
Aurinia diversifies its supplier base, collaborates with multiple contract manufacturers, maintains strategic inventory buffers, and adheres to strict GMP standards to ensure uninterrupted supply.
3. Are there any regional manufacturing partners for voclosporin?
Yes, Aurinia works with manufacturing facilities across North America, Europe, and Asia, including key partners like Samsung BioLogics in South Korea and facilities in Turkey and the UK.
4. What are the key challenges in voclosporin supply chain management?
Complex peptide synthesis processes pose manufacturing challenges. Supply disruptions can occur due to shortages of raw materials, regulatory delays, or capacity limitations, prompting the need for supply chain diversification.
5. What future developments could impact voclosporin’s supply chain?
Potential biosimilar entrants, patent expirations, or shifts in manufacturing technology could influence supplier relationships and capacity planning, emphasizing the importance of ongoing strategic sourcing.
Sources:
[1] Aurinia Pharmaceuticals official website, 2023.
[2] Bachem AG corporate reports, 2023.
[3] Samsung BioLogics press releases, 2023.
[4] WuXi AppTec manufacturing profiles, 2023.
[5] U.S. Food and Drug Administration (FDA) approvals, 2021.
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