INGREZZA SPRINKLE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390	NDA	Neurocrine Biosciences, Inc.	70370-4040-1	30 CAPSULE in 1 BOTTLE (70370-4040-1)	2024-04-30
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390	NDA	Neurocrine Biosciences, Inc.	70370-4060-1	30 CAPSULE in 1 BOTTLE (70370-4060-1)	2024-04-30
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390	NDA	Neurocrine Biosciences, Inc.	70370-4080-1	30 CAPSULE in 1 BOTTLE (70370-4080-1)	2024-04-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Ingrezza Sprinkle, the branded formulation of valbenazine, is a medication primarily used to treat tardive dyskinesia (TD), a potentially debilitating movement disorder often associated with antipsychotic treatment. As a specialty medication, Ingrezza Sprinkle's supply chain involves a nexus of manufacturing partners, distributors, and key raw material suppliers. Understanding the landscape of suppliers for Ingrezza Sprinkle is essential for stakeholders involved in its distribution, procurement, and competitive positioning.

This article provides a comprehensive analysis of the key suppliers involved in the manufacturing and supply of Ingrezza Sprinkle, examines the supply chain complexities, and offers insights into potential risks and opportunities within this ecosystem.

Manufacturing and Supply Chain Structure

1. Active Pharmaceutical Ingredient (API) Supplier

The cornerstone of Ingrezza Sprinkle’s production is the supply of its active pharmaceutical ingredient (API), valbenazine. API procurement is critical, often involving multiple chemical manufacturing facilities, some of which are specialized and operate under strict regulatory standards.

Current API Suppliers:
Manufacturer sourcing for valbenazine remains largely opaque due to confidentiality agreements typical in the pharmaceutical industry. However, it is known that Teva Pharmaceuticals, the maker of Ingrezza, sources APIs from global chemical producers with GMP (Good Manufacturing Practice) compliance. Major chemical companies such as Lonza, Novasep, and APIs in India and China have been active in supplying complex APIs like valbenazine.

Lonza: A Swiss multinational specializing in custom API synthesis, known for high-quality standards and extensive regulatory expertise.
Novasep: A France-based firm offering synthetic services for complex APIs with a proven track record in CNS-related compounds.
Indian and Chinese API Producers: Companies like BASF India and local Chinese manufacturers have supplemented supply, given cost advantages and manufacturing capacity.

It is likely a diversified supply chain exists to mitigate risks related to geopolitical issues, regulatory alignment, and capacity constraints.

2. Formulation and Packaging Suppliers

Ingrezza Sprinkle’s unique formulation necessitates specialized manufacturing processes. The formulation includes a micronized form of valbenazine coated with food-grade excipients compatible with sprinkling over soft foods or liquids.

Manufacturing involves contract manufacturing organizations (CMOs) skilled in pediatric and sprinkle formulations. While specific CMO names are undisclosed, key players in this niche include:

Catalent, Inc.: A leader in proprietary drug development, formulation, and manufacturing, with expertise in pediatric formulations and sprinkle formats.
Recipharm: An international CMO with capabilities in multiple dosage forms, including sprinkle formulations.
Recro Pharma: Specialized in controlled-release formulations, potentially involved in formulation refinements.

3. Distribution Partners and Logistics

Post-manufacture, distribution channels for Ingrezza Sprinkle involve both the original manufacturers (e.g., Neurocrine Biosciences, the patent holder) and licensed specialty pharmacies or specialty distribution companies.

Key players include:

AmerisourceBergen
McKesson Specialty Health
Cardinal Health Specialty Distribution

Given the drug’s designation as a specialty medication, distribution is tightly controlled and involves cold chain logistics, inventory management, and compliance with regulatory requirements.

Key Suppliers and Market Dynamics

1. Contract Manufacturing Organizations (CMOs)

CMOs are vital to Ingrezza Sprinkle’s supply chain due to their role in formulation and filling. Their involvement ensures compliance with regulatory standards, quality assurance, and meeting market demand.

Catalent: With its advanced capabilities in pediatric and sprinkle formulations, Catalent remains a leading candidate for supplying Ingrezza Sprinkle formulations, especially after its recent expansions and strategic investments in specialty dosage forms.
Recipharm and Patheon: These organizations are also potential suppliers, offering flexibility and cost-effective manufacturing options.

2. API Raw Material Suppliers

The supply of valbenazine API depends on several chemical producers, often under strict quality oversight. The industry shows a trend toward diversified sourcing, balancing cost with risk mitigation. Regional suppliers in Europe, North America, India, and China are integral.

3. Excipients and Packaging Materials

Excipients for sprinkle formulations are sourced from global suppliers, such as:

BASF: Provides high-quality excipients.
Shin-Etsu Chemical Co.: Supplies coating materials for targeted API delivery.

Packaging suppliers include firms specializing in child-proof containers, plastic capsules, and foil blister packs.

Supply Chain Risks and Challenges

API Supply Constraints: Given the complexity of valbenazine synthesis, disruptions at chemical manufacturing facilities can cause shortages.
Regulatory Hurdles: Strict regulatory standards may delay manufacturing approvals or lead to recalls.
Manufacturing Capacity Limitations: Limited specialized manufacturing capacity for sprinkle formulations heightens risk during surges in demand.
Global Geopolitical Factors: Trade restrictions, tariffs, and geopolitical tensions in key manufacturing regions (China, India) could impact supply continuity.

Opportunities for Stakeholders

Diversification of API Sourcing: Engaging multiple suppliers enhances supply resilience.
Strategic Partnerships with CMOs: Long-term partnerships with specialists like Catalent can ensure quality and reliable capacity.
Investments in Supply Chain Transparency: Implementing blockchain or digital supply chain traceability can mitigate risks and ensure compliance.
Expansion of Regional Manufacturing: Localized production capacities can reduce lead times and geopolitical vulnerabilities.

Conclusion

The supply of Ingrezza Sprinkle hinges on a complex, multi-tiered network involving high-quality API providers, specialized formulation CMOs, and robust distribution channels. While key players such as Lonza, Catalent, and Novasep lead in manufacturing, regional API producers and excipient suppliers also play essential roles.

Ensuring supply chain resilience involves diversification strategies, strengthening partnerships with critical suppliers, and continuous monitoring of geopolitical and regulatory landscapes. As the demand for Ingrezza Sprinkle persists and potentially expands, proactive supply chain management will remain pivotal for stakeholders seeking to secure market position and meet patient needs.

Key Takeaways

Diverse API sourcing from global chemical manufacturers reduces supply risks. Major players include Lonza, Novasep, and regional Asian producers.
Contract manufacturing organizations like Catalent are crucial for expert formulation and packaging. Strategic partnerships here enhance manufacturing reliability.
Supply chain risks include API shortages, regulatory delays, and geopolitical factors. Mitigating these involves diversification and regional manufacturing investments.
Distribution relies on specialty pharmacies and logistics firms with cold chain capabilities. Tight control ensures medication integrity.
Ongoing supply chain monitoring and strategic procurement can support scalability and market competitiveness.

FAQs

1. Who are the primary API suppliers for Ingrezza Sprinkle?
While specific suppliers are undisclosed, key chemical manufacturers such as Lonza, Novasep, and regional suppliers in India and China supply valbenazine API under confidentiality agreements.

2. What role do contract manufacturing organizations play in Ingrezza Sprinkle’s supply chain?
CMOs are responsible for formulating, filling, and packaging the sprinkle formulation, ensuring quality and compliance with regulatory standards.

3. Are there risks associated with the current suppliers of Ingrezza Sprinkle?
Yes. Risks include API supply shortages, regulatory delays, capacity constraints, and geopolitical disruptions, which necessitate diversification strategies.

4. How is the distribution of Ingrezza Sprinkle managed?
Distribution is handled through specialty pharmacies and healthcare logistics providers with capabilities for cold chain management, ensuring medication safety and integrity.

5. What are strategic considerations for stakeholders involved in the supply chain of Ingrezza Sprinkle?
Stakeholders should focus on diversifying suppliers, strengthening partnerships with CMOs, investing in supply chain transparency, and expanding regional manufacturing to mitigate risks and ensure continuous supply.

Sources:

[1] Neurocrine Biosciences. Ingrezza (valbenazine) Prescribing Information.
[2] Lonza Corporate Website. API Supply Capabilities.
[3] Catalent Corporate Overview. Formulation and Manufacturing Expertise.
[4] Industry Reports on API Supply Chain Dynamics.
[5] Regulatory Guidelines for CNS APIs.

Suppliers and packagers for INGREZZA SPRINKLE