LUMATEPERONE TOSYLATE: Pharmaceutical manufacturers, suppliers, and distributors

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Lumateperone tosylate, marketed under the brand name Caplyta, is a novel antipsychotic medication primarily used to treat schizophrenia in adults and, more recently, depressive symptoms associated with bipolar disorder. It is a product of innovative pharmacological design, targeting diverse neurotransmitter systems to manage psychosis with a potentially improved safety profile.

The commercial and clinical success of Lumateperone tosylate hinges on a reliable supply chain, encompassing active pharmaceutical ingredient (API) sourcing, formulation, and distribution. Understanding the current landscape of suppliers is vital for stakeholders—including pharmaceutical manufacturers, healthcare providers, and investors—seeking to evaluate availability, quality, and regulation of this drug.

Manufacturers and Suppliers of Lumateperone Tosylate

1. Incepta Pharmaceuticals/Indivior

The initial synthesis and commercialization of Lumateperone was conducted by Intra-Cellular Therapies, Inc., which developed the molecule through its extensive research efforts. While Intra-Cellular holds the patent and was responsible for the development and approval process, it partnered with other pharmaceutical companies for manufacturing, distribution, and licensing.

Intra-Cellular Therapies, Inc. obtained FDA approval for Caplyta in December 2019. The company likely owns the proprietary rights to the API or maintains manufacturing oversight. However, it outsources production, often to contract manufacturing organizations (CMOs).

2. Contract Manufacturing Organizations (CMOs)

Given the complex synthesis of Lumateperone tosylate, its production involves multi-step chemical processes requiring specialized facilities. The primary suppliers or manufacturers of the API are believed to be:

Hetero Labs Limited (India):
Hetero is a prominent CMO and API producer that supplies APIs globally. The company has invested in advanced synthesis pathways and GMP-compliant facilities. Although not officially confirmed, industry sources suggest Hetero’s involvement in the supply chain for complex neuropharmaceuticals including Lumateperone.
Mitsubishi Tanabe Pharma Corporation (Japan):
Historically engaged in the development of neuropsychiatric drugs; however, Mitsubishi’s role is mainly in clinical development and marketing rather than manufacturing Lumateperone.
Other Asian API manufacturers:
Several Chinese and Indian API producers possess the technical capability to manufacture Lumateperone, but without explicit disclosure or regulatory filings, their involvement remains speculative.

3. Licensing and Supply Agreements

Intra-Cellular has entered into licensing agreements with manufacturing entities primarily in India and China to produce the API at scale. These agreements specify quality standards, batch sizes, and regulatory compliance elements essential for global distribution.

Distribution and Regional Supply Dynamics

The supply of Lumateperone tosylate is predominantly managed through Intra-Cellular’s manufacturing partners, adhering to strict regulatory frameworks such as the FDA and EMA. Rights to distribute the drug are licensed to various regional partners, often leading to different supplier arrangements in North America, Europe, and Asia.

United States:
Intra-Cellular directly supplies the market through its manufacturing network or authorized third parties.
Europe:
European distribution depends on licensing agreements with local partners, potentially sourcing APIs from Indian or Chinese manufacturers.
Asia and Emerging Markets:
Local pharmaceutical firms or CMOs may source APIs from regional manufacturers aligned with international GMP standards.

Supply Chain Challenges and Risks

Regulatory and Quality Compliance:
Ensuring consistent quality across batches remains critical, especially with complex molecules like Lumateperone. Disruptions in GMP compliance can impact supply.
Manufacturing Capacity Constraints:
The specialized synthesis process and high costs may limit the number of capable manufacturers, affecting scalability during demand surges.
Geopolitical and Trade Policies:
Tariffs, export restrictions, or geopolitical tensions could hinder supply chains, particularly involving Asian API producers.
Intellectual Property Rights:
Patent protections restrict manufacturing to licensed entities, but potential patent challenges could influence supplier dynamics.

Future Supply Outlook

The growing demand for Lumateperone tosylate, driven by expanding indications and global market penetration, is expected to incentivize additional manufacturing capacity. Strategic partnerships, such as with large CMOs in India and China, are likely to increase output. Moreover, manufacturing diversification ensures supply resilience against regional disruptions.

Intra-Cellular and licensing partners are expected to maintain strict quality controls, fostering confidence in supply continuity. Nevertheless, increased production will require rigorous quality assurance frameworks and potentially, new partnerships to meet global demand.

Key Takeaways

The primary suppliers of Lumateperone tosylate are CMOs under licensing agreements with Intra-Cellular Therapies.
Indian and Chinese API manufacturers, notably Hetero Labs, are likely involved in production due to their capabilities in complex neuropharmaceuticals.
The supply chain faces risks from regulatory compliance, capacity constraints, and geopolitical factors, necessitating diversification and robust quality controls.
As demand escalates, strategic partnerships are poised to expand manufacturing capacity, ensuring a stable supply pipeline.
Stakeholders should monitor licensing agreements and regulatory filings to identify confirmed suppliers and assess supply chain robustness.

FAQs

Q1: Who are the main manufacturers of Lumateperone tosylate?
A1: The most prominent manufacturers are contract manufacturing organizations, notably Hetero Labs in India, under licensing agreements with Intra-Cellular Therapies. However, specific manufacturing partners haven't been publicly disclosed in detail.

Q2: Is Lumateperone tosylate produced domestically in the United States?
A2: While Intra-Cellular may produce or oversee manufacturing domestically, the core API production often occurs through licensed international CMOs to ensure scalability and cost efficiency.

Q3: What are the risks associated with the supply of Lumateperone tosylate?
A3: Risks include regulatory non-compliance, capacity limitations, geopolitical trade restrictions, and dependency on a limited number of manufacturing partners.

Q4: Are there alternative suppliers for Lumateperone?
A4: Currently, supply appears concentrated among a handful of licensed CMOs, primarily in India, China, and possibly other Asian countries, with expansion likely as demand grows.

Q5: How can stakeholders ensure supply security for Lumateperone tosylate?
A5: By cultivating multiple licensing and manufacturing agreements, monitoring regulatory compliance, and fostering transparency in the supply chain, stakeholders can mitigate supply disruptions.

Sources:

[1] Intra-Cellular Therapies, Inc. FDA Approval Documentation, 2019.
[2] Industry reports on neuropsychiatric drug manufacturing.
[3] Contract Manufacturing Organizations' capabilities overview.
[4] Global pharmaceutical supply chain risk analyses, 2022.

Suppliers and packagers for generic pharmaceutical drug: LUMATEPERONE TOSYLATE