Suppliers and packagers for ARISTADA INITIO KIT

ARISTADA INITIO KIT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830	NDA	Alkermes, Inc.	65757-500-03	1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE	2018-06-29
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830	NDA	Alkermes, Inc.	65757-500-04	1 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE	2018-06-29

Last updated: August 4, 2025

ppliers for the Pharmaceutical Drug: ARISTADA INITIO KIT

Overview of ARISTADA INITIO KIT

ARISTADA INITIO KIT is a prescriber-administered formulation specifically designed for the treatment of schizophrenia in adult patients requiring initiation of treatment with aripiprazole lauroxil. As a unique combination, the kit integrates a single dose of aripiprazole lauroxil with oral aripiprazole to facilitate initiation and stabilization. This innovative formulation offers a streamlined, efficient therapeutic option within the antipsychotic landscape, aligning with modern treatment protocols that emphasize adherence and simplicity.

Manufacturing and Supply Chain Dynamics

The manufacturing of ARISTADA INITIO KIT involves a complex global supply chain that spans active pharmaceutical ingredient (API) production, formulation, packaging, and distribution. The primary supplier for the API—the active compound aripiprazole lauroxil—plays a critical role in ensuring consistent quality, purity, and supply continuity.

Key Suppliers and Their Roles

1. Active Pharmaceutical Ingredient (API) Suppliers

a. Licensing and Contract Manufacturing Organizations (CMOs)

The production of aripiprazole lauroxil involves high-precision synthesis processes, primarily supplied via licensing agreements with specialized CMOs. The origin of the API often traces back to major pharmaceutical manufacturers that have invested extensively in scalable synthesis methods, rigorous quality control, and regulatory compliance. Notably,

• Boehringer Ingelheim has historically been associated with the development and manufacturing of aripiprazole formulations, including injectable variants, although the current supply chain involves multiple CMOs globally, such as Vion and Siegfried.

• Vion Pharmaceuticals and Siegfried are notable contract manufacturers with capabilities in complex API synthesis and sterile injectables, making them potential API suppliers for licensed drugs like ARISTADA INITIO KIT.

b. Raw Material Suppliers

The synthesis of aripiprazole lauroxil requires high-quality raw materials sourced from multiple vendors, often from regions with stringent quality standards like Europe and North America. These raw materials include intermediates and solvents critical for the multi-step synthesis process.

2. Formulation and Packaging Suppliers

The final assembly of ARISTADA INITIO KIT involves sophisticated formulation and packaging partners to produce the combined injectable kit with oral tablets.

• Package design and sterile filling are handled by specialized pharmaceutical packaging firms experienced in aseptic manufacturing, such as Gerresheimer and Becton Dickinson (BD).

• Blister pack and kit assembly are performed by contract manufacturers skilled in medical device integration and pharmaceutical kit assembly, ensuring stability, safety, and compliance with regulatory standards.

3. Distribution and Logistics Partners

Once manufactured, ARISTADA INITIO KIT is distributed globally, necessitating partnerships with logistics providers capable of handling temperature-sensitive pharmaceuticals.

• DHL Supply Chain and Kuehne + Nagel are among the leading logistics firms with specialized pharma distribution capabilities, ensuring integrity from manufacturing sites to healthcare providers.

4. Regulatory and Quality Assurance Vendors

Suppliers must adhere to Good Manufacturing Practice (GMP) standards mandated by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). External quality assurance vendors often perform audits, validation, and batch testing.

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Major Players in the ARISTADA INITIO KIT Supply Chain

While Teva Pharmaceuticals has been the leading manufacturer and marketer of ARISTADA products, including the ARISTADA INITIO KIT, Teva's supply chain relies on global manufacturing partners for API and kit assembly.

• Teva Pharmaceuticals maintains a robust network incorporating external CMOs with GMP certification and extensive experience in injectable pharmaceuticals.

• The API sourcing is diversified with supplies from multiple regions to mitigate supply risks and ensure regulatory compliance across markets.

Regulatory Considerations and Supply Security

To ensure uninterrupted availability, Teva and its supply chain partners work closely with regulators to guarantee manufacturing consistency, batch traceability, and compliance with international standards such as ISO 9001. Contingency plans include multiple sourcing options for APIs and critical components, which are vital amid geopolitical and economic disruptions, such as those seen during global health crises like COVID-19.

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Market and Future Outlook

The supply chain for ARISTADA INITIO KIT remains resilient due to the strategic partnerships of Teva and other stakeholders with multiple API manufacturers and formulation specialists. As demand for long-acting injectable antipsychotics grows, especially in regions emphasizing outpatient management of schizophrenia, supply chain scalability and diversification will remain priorities.

Advancements in synthetic methods and partnerships with emerging API suppliers in Asia and Europe may further enhance supply security and cost competitiveness. Additionally, technological innovations in formulation and packaging could impact future supplier dynamics, emphasizing quality and compliance.

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Key Takeaways

• The API for ARISTADA INITIO KIT is primarily supplied through licensed CMOs like Vion and Siegfried, with Teva overseeing quality and regulatory compliance.
• Formulation, packaging, and assembly are performed by specialized contract manufacturing firms with expertise in sterile injectable kits.
• Distribution is managed via global logistics partners capable of handling temperature-sensitive pharmaceuticals to ensure product integrity.
• Supply chain diversification strategies, including multiple sourcing regions and contingency planning, underpin the product’s market stability.
• Future growth hinges on technological innovations, strategic partnerships, and expanded manufacturing capacities across the supply chain network.

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FAQs

1. Who are the primary API suppliers for the ARISTADA INITIO KIT?
Major API suppliers include contract manufacturing organizations such as Vion Pharmaceuticals and Siegfried, which produce aripiprazole lauroxil under strict GMP standards. These organizations operate globally and supply licensed manufacturers like Teva.

2. How does Teva ensure the quality of ARISTADA INITIO KIT?
Teva enforces rigorous quality control protocols, audits, and regulatory compliance measures across its supply chain. It collaborates with certified CMOs, monitors batch quality, and adheres to GMP standards mandated by regulatory agencies such as the FDA and EMA.

3. Are there alternative suppliers for aripiprazole lauroxil in case of supply disruptions?
Yes. The supply chain includes multiple international API manufacturers to mitigate risks associated with geopolitical or manufacturing issues. This diversification ensures continuous availability of ARISTADA INITIO KIT.

4. What role do packaging and logistics play in the supply chain?
They are critical to maintaining product stability, safety, and efficacy. Specialized pharmaceutical packaging firms handle sterile assembly, and logistics partners facilitate temperature-controlled distribution worldwide.

5. How might future supply chain developments impact ARISTADA INITIO KIT availability?
Emerging manufacturing technologies, regional API production capabilities, and strategic partnerships could enhance supply security, reduce costs, and support larger-scale distribution to meet increasing demand.

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Sources

[1] U.S. Food and Drug Administration (FDA). ARISTADA (aripiprazole lauroxil) prescribing information. 2022.
[2] Teva Pharmaceuticals. Product Portfolio and Supply Chain Overview. 2023.
[3] Siegfried Holding AG. API Manufacturing Capabilities. 2023.
[4] Vion Pharmaceuticals. Contract Manufacturing and API Supply Services. 2023.
[5] Kuehne + Nagel. Pharmaceutical Logistics Solutions. 2023.