Last updated: June 1, 2026
AMITIZA (lubiprostone) supply chains in the US are anchored by defined roles: drug substance and drug product manufacturing, plus packaging and distribution. The key “suppliers” that matter for procurement, competitive entry risk, and IP challenge mapping are the labeled contract manufacturers and marketing/distribution entities tied to NDA holder recordkeeping and labeling.
Which companies supply AMITIZA (lubiprostone) drug product in the US?
Answer (high level): AMITIZA is marketed in the US under Allergan’s commercial distribution footprint (AbbVie affiliation), with manufacturing typically performed by named contract manufacturing organizations for oral dosage forms. Those manufacturing roles show up in FDA labeling and inspection histories tied to NDA recordkeeping.
How do “suppliers” break down for AMITIZA?
In practice, buyers should segment suppliers into four buckets:
- Marketing/distribution entity (responsible for US commercialization and labeled product availability).
- Drug product manufacturer (final tablet/capsule manufacturing site(s)).
- Drug substance (API) supplier (lubiprostone API makers and intermediates, sometimes via toll manufacturing).
- Packaging and secondary labeling supplier (bottling, blistering, unit-dose packing, label application).
What are the named AMITIZA (lubiprostone) manufacturing and packaging suppliers?
Answer: This section requires the specific set of labeled manufacturers/packers shown on the current US prescribing information (NDA labeling) and/or the FDA Drugs@FDA listing’s “Manufactured for” / “Distributed by” / “Manufactured by” lines. Without the exact labeling text, no complete, accurate supplier roster can be produced.
Who supplies AMITIZA API (lubiprostone) drug substance?
Answer: Identifying the lubiprostone API supplier set requires the NDA’s drug substance manufacturing declarations and/or detailed site lists in FDA inspection databases tied to the specific chemistry manufacturing controls (CMC). Without those site-specific declarations, an accurate API supplier list cannot be generated.
Which companies provide AMITIZA through contract manufacturing organizations?
Answer: The contract manufacturing organizations for AMITIZA are site-specific and appear in labeling and FDA listing records. Without the labeled site roster, any company list would risk inaccuracy.
What licensing or marketing arrangements affect AMITIZA supply?
Answer: AMITIZA is marketed in the US by a single commercial sponsor with distribution responsibility, but manufacturing can be outsourced. The supply risk and “supplier substitution” dynamics depend on:
- NDA-registered manufacturing sites for drug product and packaging
- NDA supplements that transfer sites or change packaging configurations
- OOS handling and re-qualification requirements
How does AMITIZA supplier switching impact generic or authorized-entry readiness?
Answer: Supplier switching can affect launch timing through:
- approval of alternative manufacturing sites under NDA supplements
- stability bridging and packaging configuration requirements
- re-qualification of controlled-substance-free but highly controlled API and finished-goods release systems
This matters most when generics seek to narrow formulation and process differences while maintaining equivalent dissolution and impurity profiles.
Key Takeaways
- “Suppliers for AMITIZA” should be treated as labeled manufacturer/packer sites plus NDA-registered roles, not generic reseller names.
- A complete supplier roster must come from current US AMITIZA labeling lines (manufactured for/for distribution by) and the associated FDA site listings.
- API vs drug product vs packaging suppliers require different sources and NDA-specific site mapping.
FAQs
- Which sites manufacture AMITIZA tablets in the US?
- Who supplies lubiprostone API for AMITIZA?
- Are there multiple AMITIZA packaging suppliers (bottles vs blister)?
- How can manufacturing site changes affect AMITIZA availability?
- Do AMITIZA supplier contracts influence generic launch timing or supply substitution?
References
- FDA. Drugs@FDA (AMITIZA, lubiprostone).
- FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for AMITIZA.
- US Prescribing Information for AMITIZA (lubiprostone), current version (manufactured/packaged/distributed-by lines).
