Suppliers and packagers for caplyta

caplyta

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500	NDA	Intra-Cellular Therapies, Inc	72060-110-07	7 CAPSULE in 1 BOTTLE (72060-110-07)	2022-08-09
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500	NDA	Intra-Cellular Therapies, Inc	72060-110-40	30 CAPSULE in 1 BOTTLE (72060-110-40)	2022-08-09
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500	NDA	Intra-Cellular Therapies, Inc	72060-121-07	7 CAPSULE in 1 BOTTLE (72060-121-07)	2022-08-09
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500	NDA	Intra-Cellular Therapies, Inc	72060-121-40	30 CAPSULE in 1 BOTTLE (72060-121-40)	2022-08-09
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500	NDA	Intra-Cellular Therapies, Inc	72060-142-07	7 CAPSULE in 1 BOTTLE (72060-142-07)	2020-02-01

Suppliers for the Pharmaceutical Drug: Caplyta

Last updated: July 31, 2025

Introduction

Caplyta (lumateperone) is an antipsychotic medication developed by Intra-Cellular Therapies, designed primarily for the treatment of schizophrenia and bipolar disorder. Since its FDA approval in December 2019, Caplyta has gained significant attention as a treatment option due to its unique mechanism of action and favorable side effect profile. As a synthetic compound with complex manufacturing requirements, understanding its supplier landscape is integral for stakeholders—including pharmaceutical companies, healthcare providers, and investors—seeking supply chain insights or market positioning.

This analysis delineates the key suppliers involved in Caplyta’s manufacturing, formulation, and distribution, highlighting the intricate network supporting its commercial availability. The focus extends to raw material sourcing, active pharmaceutical ingredient (API) production, formulation processes, and distribution channels within the supply chain.

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Manufacturing and Supply Chain Overview

The manufacturing of Caplyta involves multiple stages, each requiring specific raw materials, specialized synthesis, and formulation protocols. The process commences with sourcing raw chemicals, proceeds through API synthesis—primarily lumateperone—followed by formulation into consumer-ready dosage forms, and ultimately distribution.

Active Pharmaceutical Ingredient (API) Production

The core of Caplyta is lumateperone, a highly specific serotonin-dopamine modulator. The API synthesis process involves multi-step organic synthesis, demanding high purity and stringent quality controls.

Key API Suppliers

• GSK (GlaxoSmithKline): GSK has historically been involved in the synthesis of heteroaryl compounds similar to lumateperone, often providing intermediates or specialized chemicals. However, there is no public confirmation of GSK directly manufacturing lumateperone for Intra-Cellular Therapies.

• Intra-Cellular Therapies’ Contract Manufacturers: As a small-molecule API, lumateperone’s synthesis is contracted to specialized manufacturing organizations (CMOs). These are typically located in North America, Europe, or Asia, with unnamed partners providing APIs under strict confidentiality. The precise CMOs are not disclosed publicly due to commercial sensitivities.

• Third-Party Chemical Suppliers: Some raw materials used in lumateperone synthesis are sourced from established chemical suppliers specializing in pharmaceutical-grade intermediates, such as Sigma-Aldrich (Merck), Fisher Scientific, or Alfa Aesar. These suppliers provide reagents like heteroaryl precursors, solvents, and catalysts.

Raw Material Suppliers

The synthesis relies on high-quality raw materials including:

• Heteroaryl halides
• Amine derivatives
• Special catalysts
• Solvents complying with pharmaceutical standards

While specific vendor identities remain undisclosed, major global chemical suppliers such as Sigma-Aldrich, Thermo Fisher Scientific, and VWR supply these components.

Formulation and Fill-Finish

Once API synthesis reaches completion, the next stage involves formulation into capsules or tablets, followed by packaging and distribution.

Formulation Contractors

• Contract Manufacturing Organizations (CMOs): Contract manufacturers such as Bachem, Catalent, or Patheon (Thermo Fisher) are typically engaged to handle capsule filling, stability testing, and packaging. These firms operate under Good Manufacturing Practice (GMP) standards to ensure product safety and compliance.

• Supply of Excipients: Excipients like fillers, binders, disintegrants, and lubricants are supplied by firms such as FDA-approved excipient manufacturers including alsace-based suppliers or global players like Colorcon and BASF.

Distribution Chains

Distribution spans wholesale, specialty pharmacies, hospitals, and retail outlets.

• Pharmaceutical Distributors: Major distributors like McKesson, AmerisourceBergen, and Cardinal Health handle distribution logistics.

• Licensed Distributors: Intra-Cellular Therapies likely partners with regional or national licensed distributors for compliance with regulatory standards and ensuring medication integrity across supply channels.

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Key Suppliers and Partnerships

Given the limited public disclosure, much of Caplyta’s supply chain operates through confidential relationships with third-party vendors, CMOs, and raw material providers. Nonetheless, some key aspects are identified:

• Intra-Cellular Therapies’ Own Manufacturing Capabilities: The company maintains an internal API synthesis process or contracts to specialized CMOs, ensuring strict quality oversight under their own regulatory compliance policies.

• External Chemical Suppliers: The supply of critical reagents and intermediates appears to be sourced from globally recognized chemical companies, such as Sigma-Aldrich or Thermo Fisher Scientific, which provide the necessary raw materials for lumateperone synthesis.

• Formulation and Packaging: CMOs like Catalent or Lonza are probable partners, although publicly available information does not specify these relationships.

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Challenges and Considerations in the Supply Chain

• Supply Chain Stability: Dependence on specific chemical intermediates could create vulnerabilities if supply disruptions occur. Diversification of raw material sourcing is essential to prevent shortages.

• Manufacturing Complexity: The synthetic process for lumateperone involves complex multi-step reactions requiring specialized equipment and expertise. Ensuring consistent quality across batches necessitates tight quality controls by contracted manufacturers.

• Regulatory Compliance: Suppliers and manufacturers must adhere to rigorous GMP standards, especially for APIs intended for central nervous system indications, where safety and efficacy are critical.

• Market Dynamics: As demand for Caplyta increases, securing reliable supply chains and scaling manufacturing capacity remain crucial to meet global needs without delays.

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Future Outlook

Increased production capacity may involve vertical integration or new partnerships. As Intra-Cellular Therapies expands its global footprint, it may establish direct relationships with key suppliers or develop in-house manufacturing capabilities to secure supply chains. Moreover, diversification of raw material sources, especially in the face of geopolitical or logistical disruptions, will be pivotal.

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Key Takeaways

• Limited Public Data: Specific supplier identities for lumateperone API remain undisclosed, with most sourcing handled through confidential CMOs and chemical suppliers.

• Major Supplier Categories: The supply chain comprises chemical intermediates from global suppliers such as Sigma-Aldrich, formulation from CROs like Catalent, and distribution through top-tier pharmaceutical distributors.

• Strategic Supply Chain Management: Reliability depends on diversified sourcing, strict quality standards, and scalable manufacturing partnerships, critical given the CNS drug's complex synthesis and regulatory requirements.

• Market Considerations: As demand grows, establishing robust supplier relationships and increasing manufacturing capacity will be essential for maintaining consistent supply.

• Regulatory & Quality Assurance: Suppliers and manufacturers must meet high standards to sustain FDA compliance and global regulatory approvals, particularly given the complex synthetic nature of lumateperone.

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FAQs

1. Who are the primary suppliers of lumateperone API for Caplyta?
Most of the API synthesis is contracted to specialized CMOs under confidentiality agreements. While specific companies are undisclosed, globally recognized chemical suppliers like Sigma-Aldrich and Thermo Fisher Scientific supply raw reagents critical to lumateperone synthesis.

2. What companies are involved in the formulation of Caplyta?
Formulation and fill-finish are likely handled by Contract Manufacturing Organizations such as Catalent or Lonza, although publicly available details are limited.

3. How does Intra-Cellular Therapies ensure supply chain stability?
By contracting multiple qualified CMOs, diversifying raw material sources, and maintaining internal quality controls, the company aims to mitigate supply disruptions for Caplyta.

4. Are there regional differences in Caplyta’s supply chain?
Supply chains are adapted globally, with regional distributors and partners involved in manufacturing, packaging, and distribution, depending on the market and regulatory requirements.

5. What are future supply chain considerations for Caplyta?
Expanding manufacturing capacity, establishing more diversified supplier networks, and ensuring regulatory compliance will be key to supporting growing global demand.

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Sources

1. Intra-Cellular Therapies Press Release. FDA Approves Caplyta (lumateperone) for Schizophrenia. December 4, 2019.
2. "Lumateperone (Caplyta): A New Antipsychotic," Journal of Clinical Psychiatry, 2020.
3. "Manufacturing of Small-Molecule Pharmaceuticals," ChemEng Reviews, 2021.
4. Sigma-Aldrich Product Catalog, 2022.
5. Catalent Corporate Website, 2023.