Last updated: April 26, 2026
Who Supplies REXULTI (Brexpiprazole)?
REXULTI is a branded pharmaceutical product (brexpiprazole) that is distributed in the U.S. by Otsuka America Pharmaceutical, Inc. and manufactured through contract manufacturing and fill-finish partners tied to product availability and packaging needs. Public-facing supply information for REXULTI is largely controlled through FDA listing data (e.g., drug product labeling/labeler and NDC distribution networks) and through company disclosures in regulatory filings and adverse event and product-quality documentation.
What entity is the “labeler” for REXULTI in the U.S.?
REXULTI is marketed in the U.S. under the following labeler identity:
| Attribute |
Value |
| U.S. marketing authorization holder / labeler on product labeling |
Otsuka America Pharmaceutical, Inc. |
| Active ingredient |
Brexpiprazole |
| Brand |
REXULTI |
This labeler relationship is reflected in how FDA drug products are listed and how the product appears on U.S. prescribing information and labeling systems. Sources include the prescribing information and U.S. FDA product listings. [1], [2]
Who manufactures REXULTI tablets?
REXULTI is produced via established pharmaceutical supply chains using contract manufacturing and packaging/fill-finish operations. The specific manufacturer names vary by strength and packaging configuration, and they appear in product labeling and/or FDA-reviewed product documentation for the finished dosage form.
At a high level, the supply chain for REXULTI in the U.S. is structured as:
- Otsuka America Pharmaceutical, Inc. controls commercial supply and distribution.
- Finished dosage manufacturers (identified in labeling/FDA product documentation) manufacture and package brexpiprazole tablets by NDC/strength.
- Secondary packaging and distribution partners support fulfillment through wholesaler channels.
Because finished-dose manufacturing can differ by site and by NDC, the defensible way to identify the true “suppliers” for each exact product configuration is to map NDC to manufacturer name(s) using FDA drug product databases and the corresponding label/NDC-specific documentation. Those sources are where manufacturer/site names are reliably anchored. [1], [3]
What does “supplier” mean for REXULTI in practice?
For procurement, vendor qualification, and risk mapping, suppliers typically split into four tiers:
| Tier |
Supplier type |
What it impacts |
| Tier 1 |
Finished-dose manufacturer / packager (site-level) |
Batch release risk, capacity, and quality systems |
| Tier 2 |
API manufacturer (brexpiprazole substance) |
Raw material availability and GMP compliance |
| Tier 3 |
Contract testing / quality labs |
Analytical capacity and release timelines |
| Tier 4 |
Logistics and distribution |
Lead times, warehouse capacity, and cold-chain needs (if any) |
Public sources more consistently identify Tier 1 (finished-dose labeling and NDC configuration) than Tier 2 (API vendor names). The API supplier identity is frequently held within confidential supply agreements and is not always enumerated in public labeling. Product-quality documents and FDA submissions may disclose details at the application level, but those are not always surfaced in a way that yields a clean, procurement-ready list of “API suppliers” across all commercial strengths. [2], [3]
Which public sources identify REXULTI suppliers?
The most reliable public anchors for supply-chain entity identification are:
- FDA prescribing information / U.S. product labeling (labeler and sometimes manufacturer/site details on the carton/label) [1]
- FDA “Drugs@FDA” product record for REXULTI, which is the index for the application, label, and product metadata [2]
- FDA drug product listing systems (NDC-level mappings) that link NDCs to specific labeler/manufacturer and packaging configuration metadata [3]
How to map supplier identities to REXULTI strengths
REXULTI exists in multiple oral tablet strengths, and supplier identifiers can differ by NDC configuration. The operational approach for an actionable supplier list is:
- Select the exact NDC(s) for each strength (e.g., tablets by mg strength and package size).
- Use FDA listing data to extract the labeled manufacturer/packager information associated with those NDCs.
- Cross-check with the prescribing information label/vendor statements embedded in the product record for consistency.
This NDC-to-manufacturer mapping is the basis for a procurement-ready “supplier list” rather than a single generic manufacturer statement that can be strength-dependent. [2], [3]
What suppliers are listed for REXULTI on FDA-linked product documentation?
From the publicly available records used for U.S. product labeling and FDA indexing:
- The commercial labeler is Otsuka America Pharmaceutical, Inc. [1], [2]
- The manufacturing and packaging sites must be tied to NDC-level documentation within FDA product listings (the supplier names are present at that resolution). [3]
Supplier landscape summary
| Category |
Supplier identity shown publicly |
| Commercial U.S. labeler / distributor |
Otsuka America Pharmaceutical, Inc. [1], [2] |
| Finished-dose manufacturer(s) |
NDC-specific manufacturer/packager entries in FDA listings [3] |
| API manufacturer(s) |
Not consistently exposed as a simple public list in label text; often not published as a procurement-facing vendor roster in the sources above [2], [3] |
Key Takeaways
- Otsuka America Pharmaceutical, Inc. is the U.S. labeler/distributor for REXULTI (brexpiprazole). [1], [2]
- Finished-dose manufacturing suppliers are NDC-specific and should be identified through FDA NDC-linked product listing metadata tied to each strength/package. [3]
- A procurement-grade supplier roster for “REXULTI suppliers” depends on NDC mapping, not a single company name.
FAQs
1) Who is the marketing/distribution company for REXULTI in the U.S.?
Otsuka America Pharmaceutical, Inc. is the U.S. labeler/distributor for REXULTI. [1], [2]
2) Are REXULTI tablet manufacturers the same across all strengths?
Not reliably. Finished-dose manufacturer/packager identifiers can differ by NDC and packaging configuration, so strengths must be mapped via FDA listing metadata. [3]
3) Is the API supplier for brexpiprazole listed in public REXULTI labeling?
Public label text does not consistently publish a simple, consolidated list of API vendors. FDA-linked product records are the primary starting point, but supplier names are not always exposed at the API vendor level in the same way as labeler/manufacturer mapping. [2], [3]
4) Where is the authoritative place to identify manufacturer/packager entities for procurement?
Use FDA NDC-linked drug product listing data to extract manufacturer/packager entries for the exact strength/package. [3]
5) Does Drugs@FDA list supplier/manufacturer sites for REXULTI?
Drugs@FDA anchors the application and label record; site-level manufacturer details are typically resolved via the NDC-level listing metadata tied to the product configurations. [2], [3]
References
[1] Otsuka America Pharmaceutical, Inc. (2024). REXULTI (brexpiprazole) prescribing information. U.S. Food and Drug Administration.
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: REXULTI (brexpiprazole).
[3] U.S. Food and Drug Administration. (n.d.). FDA Drug Registration and Listing / drug product listing (NDC-level listings).
