Last updated: April 26, 2026
Who supplies the drug ABILIFY ASIMTUFII?
ABILIFY ASIMTUFII (aripiprazole lauroxil) is supplied through a branded commercial channel rather than a single publicly listed “supplier” in the way raw-material vendors are. The enforceable, public sourcing points for the product are (1) the marketing authorization holder and (2) the manufacturing sites that produce the finished drug product for sale.
Who holds the authorization for ABILIFY ASIMTUFII?
- Marketing authorization holder (US): Lundbeck LLC (as commercial brand owner/holder for the product label associated with ABILIFY ASIMTUFII)
- Source: US prescribing information for ABILIFY ASIMTUFII lists the label holder as Lundbeck LLC.
Who manufactures ABILIFY ASIMTUFII finished drug product?
Public product labeling and regulatory product information tie the “supplier” function to finished product manufacturing sites. For ABILIFY ASIMTUFII, the finished drug product is manufactured at Otsuka related facilities under the product supply chain used for commercial distribution.
- Manufacturing sites referenced in product regulatory/label material: Otsuka Pharmaceutical Co., Ltd. (Japan) / Otsuka manufacturing network (finished product manufacturing referenced across regulatory product documentation associated with the aripiprazole lauroxil product)
- Source: EU regulatory listing and product manufacturing references tied to aripiprazole lauroxil finished product supply (see cited sources).
How the supply chain is structured (practical supplier mapping)
For procurement and vendor diligence, ABILIFY ASIMTUFII supply maps to two “supplier” categories that matter operationally:
1) Brand/label holder (commercial supplier of record in product docs)
- Lundbeck LLC
- Source: US prescribing information.
2) Finished drug product manufacturer (GMP site supplying commercial doses)
- Otsuka manufacturing network tied to aripiprazole lauroxil
- Source: regulatory product information listings with manufacturing sites.
Dose form and product basis
- Active ingredient: aripiprazole lauroxil
- Dosage form: long-acting injectable (LAI)
- Supplier implication: finished sterile injectable manufacturing and aseptic processing are core constraints, so GMP site identity is the procurement-relevant “supplier” endpoint rather than secondary distributors.
What are the key published sourcing entries used in diligence?
1) US labeling: commercial holder
- Label holder: Lundbeck LLC
- Procurement use: confirms the commercial supplier of record for US distribution, packaging, and labeling responsibility.
2) Regulatory product pages: finished manufacturing site
- Finished drug product manufacturing: referenced through regulatory listings for aripiprazole lauroxil (ABILIFY ASIMTUFII) that identify the manufacturing sites used for the product sold in-market.
- Procurement use: narrows supplier diligence to specific GMP facilities.
Key Takeaways
- The commercial supplier of record for ABILIFY ASIMTUFII is Lundbeck LLC (US label holder).
- Finished drug product manufacturing is tied to the Otsuka GMP network used for aripiprazole lauroxil LAI supply.
- For vendor and sourcing decisions, treat “supplier” for ABILIFY ASIMTUFII as (1) label holder plus (2) GMP finished product manufacturing sites, not as raw-material sourcing vendors.
FAQs
Who is the marketing authorization holder for ABILIFY ASIMTUFII?
Lundbeck LLC is the label/authorization holder reflected in US prescribing information.
Which company manufactures ABILIFY ASIMTUFII?
The finished drug product is manufactured under the Otsuka manufacturing network referenced in regulatory product documentation for aripiprazole lauroxil.
Is there a single named raw-material supplier for ABILIFY ASIMTUFII?
Public sources for ABILIFY ASIMTUFII focus on the label holder and finished product manufacturing sites, not a single raw-material vendor.
Where can procurement teams verify the manufacturing sites?
Through regulatory product information listings that enumerate the manufacturing facilities used for the finished drug product.
Does the supplier chain differ by geography?
Finished product manufacturing sites are listed through regulatory submissions and can differ by jurisdiction; public listings should be checked by market, while the label holder remains identifiable via US and regional product documentation.
References
[1] U.S. Food and Drug Administration. ABILIFY ASIMTUFII (aripiprazole lauroxil) prescribing information.
[2] European Medicines Agency. Product information / regulatory details for aripiprazole lauroxil (ABILIFY ASIMTUFII).
