Last updated: April 25, 2026
Who manufactures alvimopan (ALVIMOPAN) and how is it supplied to the market?
ALVIMOPAN is supplied to the US market by Janssen Biotech, Inc. (subsidiary of Johnson & Johnson) through its branded product supply arrangements.
- Drug name / active: Alvimopan
- Brand: Entereg
- Company (market supply): Janssen Biotech, Inc.
- Regulatory listing: U.S. product listing in FDA’s “Drugs@FDA” database ties product labeling and commercial supply to Janssen Biotech, Inc. (Entereg). [1]
Which manufacturing entities are tied to the product record?
FDA product records for branded drugs typically list (1) manufacturer(s) for drug substance and (2) manufacturer(s) for finished drug product, plus marketing authorization holders.
For alvimopan (Entereg), the FDA product record identifies the commercial sponsor and the manufacturing parties associated with the marketed product. The authoritative “which suppliers” answer is the set of labeled manufacturing sites and/or licensees shown on the FDA product record for Entereg. [1]
Which supplier inputs are most relevant for alvimopan?
A practical way to map “suppliers” for a pharmaceutical product is to separate:
- Regulatory-market entities (label holder and marketed product manufacturer)
- Drug-substance and drug-product manufacturing sites (the physical supply chain)
- Specialty component suppliers (packaging, contract fill-finish, and sterile handling where relevant)
For Entereg (alvimopan), the controlling, auditable supplier set is the labeled manufacturing and marketing entities in the FDA product record, because these are the parties tied to the product’s commercial release and compliance obligations. [1]
Supplier map for ALVIMOPAN (Entereg)
| Supply-chain node |
Supplier / entity |
Evidence basis |
| Market supply / label holder |
Janssen Biotech, Inc. |
FDA product listing for Entereg links product to Janssen Biotech, Inc. [1] |
| Finished drug product manufacturing |
Listed manufacturer(s) tied to Entereg product record |
FDA “Drugs@FDA” product record identifies manufacturing entities for the marketed strength/form. [1] |
| Drug substance manufacturing |
Listed manufacturer(s) tied to Entereg product record |
FDA “Drugs@FDA” product record indicates drug substance manufacturing parties where disclosed. [1] |
Source note: FDA “Drugs@FDA” is the single source that consistently ties marketed alvimopan supply to named entities and manufacturing details for the commercial product. [1]
What dosing form and labeling constraints affect supplier selection?
Supplier selection for a small-molecule antagonist like alvimopan is driven by the exact marketed dosage form and label-registered strengths.
- Product is branded and label-registered as Entereg
- Manufacturing sites and release testing are those registered/authorized for the labeled product in the FDA record [1]
How to use this supplier list for procurement or diligence
- Start with the FDA product record for Entereg to capture the named manufacturing entity(s) and the label holder that controls regulatory accountability. [1]
- Build the internal supplier qualification list around those entities for:
- drug substance supply (where separately listed)
- finished dosage manufacturing
- any listed additional manufacturing/packaging steps tied to the FDA record
- Tie any vendor interchange or alternative sourcing to the same regulatory manufacturing nodes; otherwise the substitute chain will not match the marketed product’s FDA-defined manufacturing responsibility. [1]
Key Takeaways
- Janssen Biotech, Inc. is the label holder/market supply entity for Entereg (alvimopan) in the FDA product record. [1]
- The supplier set that matters for an investable, auditable supply chain is the set of finished drug product and (where listed) drug substance manufacturing entities named in the FDA “Drugs@FDA” product record for Entereg. [1]
FAQs
1) Who is the primary supplier/brand owner for alvimopan (Entereg) in the US?
Janssen Biotech, Inc. is the market/label entity for Entereg in the FDA product record. [1]
2) Can I rely on non-FDA sources to identify manufacturing suppliers for alvimopan?
For compliance-grade supplier identification, the auditable supplier mapping is the FDA “Drugs@FDA” product record for Entereg, which lists the manufacturing entities tied to the marketed product. [1]
3) Are drug-substance suppliers and drug-product suppliers the same for alvimopan?
They can differ; the controlling approach is to use the FDA record, which distinguishes (where disclosed) drug substance manufacturing and finished drug product manufacturing. [1]
4) What is the best way to confirm an alternative manufacturing site is valid for supply?
Confirm the alternative site is tied to the FDA product record for the specific Entereg strength/form or is otherwise authorized within the FDA listing for the marketed product. [1]
5) What documentation should procurement teams use to qualify alvimopan suppliers?
Procurement should anchor qualifications to the named manufacturer(s) and label holder in the FDA product listing for Entereg. [1]
References
[1] U.S. Food and Drug Administration. “Drugs@FDA: Entereg (alvimopan).” FDA. https://www.accessdata.fda.gov/scripts/cder/daf/ (product record for Entereg).
