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Suppliers and packagers for generic pharmaceutical drug: VALBENAZINE TOSYLATE
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VALBENAZINE TOSYLATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-1060-1 | 30 CAPSULE in 1 BOTTLE (70370-1060-1) | 2021-04-23 |
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-1080-1 | 30 CAPSULE in 1 BOTTLE (70370-1080-1) | 2017-10-04 |
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-2040-1 | 30 CAPSULE in 1 BOTTLE (70370-2040-1) | 2018-12-14 |
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-2046-1 | 1 BLISTER PACK in 1 CARTON (70370-2046-1) / 1 KIT in 1 BLISTER PACK | 2023-08-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Valbenazine Tosylate
Introduction
Valbenazine Tosylate is a selective Vesicular Monoamine Transporter 2 (VMAT2) inhibitor predominantly used to manage tardive dyskinesia, a movement disorder resulting from long-term antipsychotic medication use. Its specialized pharmacological profile and investment in intellectual property make the supply chain unique. This article offers a comprehensive review of current suppliers, manufacturing landscape, and strategic considerations relevant to stakeholders.
Market Overview of Valbenazine Tosylate
Valbenazine was developed by Neurocrine Biosciences and gained FDA approval in 2017 under the brand name Ingrezza. Its active pharmaceutical ingredient (API), valbenazine Tosylate, has complex synthesis pathways that demand high precision, quality control, and regulatory compliance (FDA, 2017). As a relatively new entrant, it commands high pricing and limited manufacturing sources, prompting an emphasis on supplier integrity and global distribution pathways.
Key Suppliers and Manufacturers
1. Neurocrine Biosciences
Neurocrine originally developed and commercialized Valbenazine, possessing the proprietary rights over the API production process. Although primarily responsible for marketing and distribution, Neurocrine maintains strategic collaborations for API supply with specialized contract manufacturing organizations (CMOs). They collaborate with partners to ensure uninterrupted API availability, especially given regulatory constraints.
2. Contract Manufacturing Organizations (CMOs)
Given the complexity and regulatory demands, Neurocrine engages with multiple CMOs globally to source Valbenazine Tosylate. Examples include:
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Catalent Inc. — a significant player in pharmaceutical contract manufacturing, known for high-quality APIs and advanced synthesis capabilities. Catalent supplies APIs for several neuropsychiatric drugs, including VMAT2 inhibitors, with facilities compliant with current Good Manufacturing Practices (cGMP).
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Charles River Laboratories — provides custom synthesis and scalable manufacturing, entered into agreements for critical neuropharmacological APIs, including VMAT2 inhibitors.
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Samsung Biologics & LG Chem — notable Asian CMO players investing in advanced synthesis technologies suitable for complex molecules like Valbenazine.
3. Generics and International Suppliers
As patents near expiration or under licensing arrangements, multiple generic pharmaceutical manufacturers are ramping up production. Notable companies include:
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Alvogen — engaged through licensing agreements with Neurocrine for generic versions, sourcing APIs from specialized Asian manufacturers.
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Sandoz (Novartis division) — exploring biosimilar and small molecule generics, potentially including Valbenazine Tosylate, contingent on patent status.
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Sun Pharmaceutical Industries Ltd. — has the manufacturing capacity to produce complex pharmaceuticals, including neuropsychiatric APIs.
These companies often rely on imported APIs from established Asian API producers due to cost efficiencies and manufacturing competencies.
API Production and Supply Chain Dynamics
The production of Valbenazine Tosylate involves multistep chemical synthesis, notably asymmetric synthesis and chiral purification steps, demanding advanced expertise. Limited production capacity and high industry standards narrow the pool of qualified API suppliers.
Furthermore, the API's complexity and legal exclusivity necessitate strict quality assurance, batch consistency, and supply chain transparency. Alternative suppliers face regulatory hurdles and require validation, which can extend lead times.
Geopolitical and Regulatory Considerations
The global supply landscape hinges on geopolitical stability, trade policies, and regulatory compliance. US-based manufacturers benefit from manufacturing within the FDA regulatory framework, while Asian suppliers, predominantly from China and India, supply APIs under strict quality contracts.
The COVID-19 pandemic highlighted vulnerabilities in API supply chains, prompting some pharma companies to diversify suppliers and invest in strategic stockpiles.
Emerging Trends and Future Supply Landscape
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API Manufacturing Diversification: pharma firms seek multiple sources, including established Asian API producers and potential new entrants in Europe.
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Vertical Integration: Larger pharmaceutical companies explore in-house API synthesis, reducing reliance on external suppliers.
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Patent Expirations and Generics: As patent protections diminish, generic manufacturers seek to secure API supplies for cost-effective production, increasing competition.
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Regulatory Harmonization: Standardization efforts in API manufacturing and supply chain oversight aim to mitigate shortages and quality lapses.
Strategic Considerations for Stakeholders
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For Manufacturers: Establish robust partnerships with qualified CMOs, ensuring supply continuity.
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For Distributors: Secure diversified supply sources to mitigate risks of shortages.
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For Policymakers: Promote transparency and regulatory harmonization to sustain high standards while preventing supply disruptions.
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For Investors: Monitor patent expiration timelines and new entry points in API manufacturing, especially in emerging markets.
Key Takeaways
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Limited yet Critical Suppliers: The supply of Valbenazine Tosylate hinges on a handful of specialized CMOs and licensed manufacturers, primarily in North America and Asia.
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Manufacturing Complexity Restrictions: The intricate chemical synthesis needed for high-quality APIs limits supplier proliferation, emphasizing the importance of quality compliance and regulatory adherence.
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Geopolitical Risks: Supply chains are sensitive to trade tensions, pandemics, and regulatory changes, prompting diversification strategies.
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Growth of Generics: Patent expirations are likely to diversify the supplier base, increasing competition but also necessitating vigilance over API quality.
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Strategic Importance: Ensuring a resilient supply chain for Valbenazine Tosylate is critical for meeting global demand in neuropsychiatric care.
FAQs
1. Who are the primary manufacturers of Valbenazine Tosylate?
The original API production is managed by specialized CMOs aligned with Neurocrine Biosciences, including companies like Catalent. Several licensed generic manufacturers, particularly in Asia, also supply the API, contingent on licensing agreements.
2. Are there alternative suppliers for Valbenazine Tosylate?
While the supply is concentrated among a few high-quality sources, patent expiration and licensing facilitate the entry of additional generic API producers, expanding the pool of suppliers.
3. What are the main challenges in sourcing Valbenazine Tosylate APIs?
Manufacturing complexity, stringent quality control, regulatory compliance, and geopolitical factors limit supplier numbers and warrant careful qualification processes.
4. How does patent status influence the supply chain?
Patent protections restrict generic manufacturing; patent expiration enables new suppliers to enter the market, increasing competition but also requiring robust validation processes.
5. What is the outlook for Valbenazine Tosylate supply stability?
Given ongoing licensing, patent expirations, and manufacturing investments, the supply chain is expected to diversify and stabilize; however, geopolitical and regulatory risks must be continually managed.
References
[1] FDA. (2017). Ingrezza (Valbenazine) prescribing information.
[2] Neurocrine Biosciences. Company reports and pipeline updates.
[3] Marketline. (2022). Pharmaceutical Manufacturing and Supply Chain Reports.
[4] Contract Pharma. (2022). Advances in API Manufacturing for Neuropharmaceuticals.
[5] WHO. (2021). Global API Manufacturing Standards and Trends.
In conclusion, the supply chain for Valbenazine Tosylate remains concentrated among specialized high-quality manufacturers, with diversification expected through patent expiries and licensing. Stakeholders must maintain rigorous supplier qualification, monitor regulatory developments, and adapt to geopolitical shifts to ensure consistent drug availability.
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