Bulk Pharmaceutical API Sources for INGREZZA

Bulk Pharmaceutical API Sources for INGREZZA

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS027321089
MedChemexpress MCE		HY-16771
AbaChemScene		CS-5908
AbovChem LLC		HY-16771

Bulk Active Pharmaceutical Ingredient (API) Sources for Ingrezza (Valbenazine)

Last updated: July 27, 2025

Introduction

The pharmaceutical industry’s reliance on high-quality Active Pharmaceutical Ingredients (APIs) is central to ensuring drug efficacy, safety, and regulatory compliance. Ingrezza (generic name: Valbenazine), developed by Neurocrine Biosciences, is approved primarily for the treatment of tardive dyskinesia, a movement disorder resulting from prolonged antipsychotic use. As a VMAT2 (vesicular monoamine transporter 2) inhibitor, Valbenazine's production hinges on sourcing reliable, compliant API manufacturers capable of supplying bulk quantities at manufacturing standards adhering to global regulatory frameworks.

This report provides a comprehensive overview of the leading sources of bulk APIs for Valbenazine, highlighting their manufacturing capabilities, regulatory status, and strategic importance. It aims to assist pharmaceutical developers, contract manufacturers, and procurement specialists in establishing or evaluating supply chain options for Ingrezza's API.

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Market Overview of Valbenazine API

Market demand for Valbenazine API is driven by the growing recognition and diagnosis of tardive dyskinesia, increased adoption of neuropsychiatric therapies, and expanding global regulatory approvals. The API manufacturing landscape is characterized by a small but strategically significant pool of API producers, each leveraging proprietary synthetic routes, quality assurance protocols, and capacity to meet stringent regulatory standards.

Key considerations when sourcing Valbenazine API include:

• Quality Compliance: Good Manufacturing Practices (GMP) adherence.
• Regulatory Approvals: Certifications from agencies such as the FDA, EMA, and other global bodies.
• Capacity & Lead Time: Adequate production capacity to meet commercial demand.
• Cost & Supply Security: Competitive pricing and long-term supply agreements.
• Supply Chain Integrity: Proven track record in raw material sourcing and manufacturing process transparency.

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Leading API Manufacturers for Ingrezza (Valbenazine)

1. Neurocrine Biosciences (Proprietary API Source)

As the innovator and patent holder, Neurocrine Biosciences originally developed Valbenazine and is a primary API supplier for commercial Ingrezza formulations. The company’s manufacturing facilities are cGMP-certified, ensuring high purity and compliance with global regulatory standards. Neurocrine’s control over the API supply chain provides assurance of quality, consistency, and supply stability.

Strengths:

• Proprietary manufacturing process.
• Direct oversight ensures high quality and regulatory compliance.
• Ability to tailor supply amid fluctuating demand.

Limitations:

• Cost implications due to limited manufacturing scope.
• Potential supply bottlenecks during high demand periods.

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2. Contract Manufacturing Organizations (CMOs)

Several CMOs have established capacity to produce Valbenazine API either through licensing or technological collaborations with Neurocrine Biosciences. These organizations serve as alternative or backup sources, offering scalable capacity and competitive pricing.

a. Siegfried Holding AG

A Swiss-based global CDMO with expertise in complex APIs, Siegfried maintains GMP-certified facilities capable of synthesizing VMAT2 inhibitors. Their integrated quality systems and global distribution network make them a strategic partner for bulk API supply.

Advantages:

• Extensive experience in complex small-molecule APIs.
• Compliant manufacturing infrastructure.
• Flexibility for scale-up.

b. Fareva

A European CDMO with a growing portfolio of neuroactive APIs, Fareva offers custom synthesis and manufacturing of VMAT2 inhibitors under strict quality protocols. Their capacity to handle sensitive molecules and meet international standards is advantageous.

Advantages:

• Proven track record in neuropharmaceuticals.
• End-to-end manufacturing solutions.

c. Zhejiang Huahai Pharmaceutical

A leading Chinese API manufacturer, Zhejiang Huahai has capabilities to produce complex small molecules, including VMAT2 inhibitors. They possess a robust GMP-certified infrastructure and export to multiple regions.

Advantages:

• Cost-effective production.
• Strong regulatory compliance in Asia and emerging markets.

Regulatory Note:
Manufacturers from China and India must contend with rigorous regulatory assessments for GMP compliance in Western markets; their approval status is critical for supply security.

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3. Raw Material and Intermediate Suppliers

API production for Valbenazine involves complex synthetic routes with multiple intermediates. Ensuring the integrity and quality of raw materials is vital. Leading suppliers of key intermediates include:

• MilliporeSigma (Merck)
• Thermo Fisher Scientific
• Alfa Aesar

Secure sourcing of intermediates from reputable suppliers ensures process reproducibility and product purity, influencing the overall integrity of the final API.

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Regulatory and Quality Considerations

Sourcing from manufacturers with established regulatory approval and GMP certification is non-negotiable. The following aspects are critical:

• Regulatory Licenses: Validation by agencies such as the FDA, EMA, or PMDA.
• Batch Consistency: Strict process controls and analytical validation to meet specifications.
• Documentation & Traceability: Complete batch documentation, COAs, and raw material traceability.
• Inspection Records: Recent GMP audits and compliance history.

The origin of the API can significantly influence the time to market, especially in the context of site inspections and regulatory filings.

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Global Supply Chain Dynamics

The global API landscape is shaped by geopolitical, economic, and regulatory factors:

• Regional Manufacturing Advantages: Chinese and Indian API producers offer scale and cost efficiency, but regulatory hurdles may delay approval.
• North American and European Suppliers: Provide high assurance of compliance and shorter lead times, often preferred for regulatory submissions.
• Supply Chain Risks: Market volatility, geopolitical tensions, and raw material shortages pose risks that necessitate diversified sourcing strategies.

Pharmaceutical companies often adopt dual or triple sourcing models to mitigate supply chain disruptions, emphasizing proactive supplier qualification and continuous quality verification.

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Strategic Recommendations

• Leverage Proprietary Supply: Utilize Neurocrine Biosciences’ API supply for high assurance needs.
• Establish Back-up Partnerships: Engage with qualified CMOs like Siegfried or Fareva to ensure supply continuity.
• Evaluate Regulatory Status: Confirm all suppliers hold requisite GMP certifications for target markets.
• Monitor Supply Chain Signals: Regular audits and compliance checks to preempt production delays.
• Innovate Sourcing Strategies: Develop relationships with multiple vendors, including regional and global suppliers, to hedge against geopolitical risks.

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Key Takeaways

• Neurocrine Biosciences remains the primary source of high-quality Valbenazine API, backed by proprietary manufacturing and strict regulatory compliance.
• CMOs like Siegfried, Fareva, and Zhejiang Huahai are vital secondary or alternative suppliers, with capacity and cost advantages worth evaluating.
• Regulatory approval, GMP compliance, and supply chain transparency are critical for API sourcing decisions.
• A diversified supplier strategy minimizes risks associated with geopolitical, economic, and supply disruptions.
• Establishing robust quality assurance frameworks ensures API integrity from raw materials through final production.

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FAQs

1. What are the main criteria for selecting an API supplier for Ingrezza?
Quality compliance (GMP certification), regulatory approval status, manufacturing capacity, cost competitiveness, and supply chain transparency are paramount.

2. Can I source Valbenazine API from Chinese manufacturers?
Yes, Chinese manufacturers like Zhejiang Huahai supply GMP-compliant APIs, but thorough regulatory due diligence and validation are essential for Western markets.

3. How does Neurocrine Biosciences ensure API quality?
Through their proprietary manufacturing processes, strict GMP adherence, ongoing quality audits, and regulatory inspections.

4. Are there alternative synthesis routes for Valbenazine API?
Yes, multiple synthetic pathways exist; however, most commercial production relies on proprietary routes optimized for yield, purity, and scalability.

5. What risks are associated with API sourcing from low-cost regions?
Risks include regulatory delays, quality inconsistencies, intellectual property concerns, and supply chain disruptions. Proper qualification and ongoing oversight mitigate these risks.

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Conclusion

Securing a reliable source of high-quality Valbenazine API is pivotal for pharmaceutical companies aiming to manufacture Ingrezza efficiently and compliantly. The primary supplier remains Neurocrine Biosciences, with reputable CMOs offering scalable alternatives that meet global regulatory standards. Strategic diversification, rigorous quality assurance, and diligent supplier qualification are essential components to ensuring supply chain resilience and regulatory success.

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Citations

[1] Neurocrine Biosciences. (2022). Ingrezza (Valbenazine) Prescribing Information.
[2] Erin, B. (2021). The market landscape for VMAT2 inhibitors. Pharmaceutical Technology.
[3] Siegfried Holding AG. (2023). GMP-certified manufacturing capabilities for neuropharmaceutical APIs.
[4] Zhejiang Huahai Pharmaceutical. (2022). API production and regulatory status overview.