Last updated: May 28, 2026
Caplyta (lumateperone) is supplied through a branded manufacturing network tied to its NDA commercialization. However, this environment does not contain enough source data to identify specific Caplyta suppliers (drug substance manufacturers, drug product manufacturers, fill-finish partners, or packaging suppliers) with patent-grade precision.
What companies supply Caplyta (lumateperone) to the US market?
Answer: Not enough verified supplier-identifying information is available in the provided context to name drug substance and drug product suppliers for Caplyta.
Which manufacturers make lumateperone drug substance for Caplyta?
Answer: Not enough verified information to list lumateperone API suppliers.
Which companies fill-finish Caplyta and package it?
Answer: Not enough verified information to list fill-finish and packaging suppliers.
Are there multiple sources for Caplyta manufacturing?
Answer: Not enough verified information to confirm multi-site API or finished-dose manufacturing.
What is the Orange Book listing for Caplyta and what does it say about manufacturing?
Answer: Not enough verified Orange Book listing details are available in the provided context to extract listed applicants and manufacturing sites for Caplyta.
Who is listed as the NDA holder and patent owner for Caplyta?
Answer: Not enough verified Orange Book/NDA details are available here to state NDA holder and associated manufacturing information.
Does the Orange Book show listed drug product manufacturers?
Answer: Not enough verified listing details are available to extract manufacturing-site identifiers.
What contract manufacturing organizations (CMOs) support Caplyta supply?
Answer: Not enough verified information is available to name CMOs involved in API synthesis, drug product manufacturing, or packaging.
Is Caplyta made via internal Janssen manufacturing or outsourced sites?
Answer: Not enough verified information in the provided context to determine in-house vs outsourced production structure.
Which raw-material suppliers affect Caplyta supply continuity?
Answer: Not enough verified supplier-identifying information is available to name specific excipient, intermediate, or critical raw material suppliers for Caplyta.
Excipients and packaging components used in Caplyta
Answer: Not enough verified formulation bill-of-materials information is available here to identify excipient and packaging suppliers.
How do Caplyta supply risks show up in recalls, warning letters, or inspections?
Answer: Not enough verified incident or inspection data is available in the provided context to connect specific events to named suppliers.
What manufacturing sites are implicated in any Caplyta quality events?
Answer: Not enough verified supplier and quality-event details are available here.
Key Takeaways
- Caplyta supplier identification (API, drug product, fill-finish, packaging) requires specific verified listing or regulatory documentation.
- The provided context does not contain enough source detail to produce a complete and accurate supplier map for Caplyta.
FAQs
- Who is the NDA holder for Caplyta in the US?
- What does the Caplyta Orange Book entry list for manufacturing and labeling?
- Which sites manufacture lumateperone active pharmaceutical ingredient (API)?
- Which companies handle fill-finish and packaging for Caplyta tablets?
- What suppliers could be the bottleneck in Caplyta supply continuity?
References
No sources were provided in the prompt to cite.
