Suppliers and packagers for VIBERZI

VIBERZI

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075-16	2 BLISTER PACK in 1 CARTON (61874-075-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK (61874-075-08)	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075-60	1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-100-16	2 BLISTER PACK in 1 CARTON (61874-100-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK (61874-100-08)	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-100-60	1 BOTTLE in 1 CARTON (61874-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2015-10-01

Suppliers and packagers for VIBERZI

Last updated: May 26, 2026

VIBERZI suppliers: who manufactures it, API sources, and contract manufacturing options

VIBERZI (eluxadoline) is manufactured for Allergan (AbbVie) by IRD (now part of Cambrex), with API supply and formulation/packaging typically handled through a limited set of pharma-focused CDMOs and intermediates suppliers. The competitive supplier map is constrained by the drug’s controlled-substance-like prescribing controls, US commercial scale, and FDA-regulated manufacturing records tied to the NDA and Orange Book-listed patents.

Who are the suppliers of VIBERZI (eluxadoline) in the US?

Commercial supply for VIBERZI is tied to the drug product manufacturing and labeling records in the FDA CDER databases (NDA and Current/Archived Drug Label) and to the controlled manufacturing of the eluxadoline API and final dosage forms. In practice, buyers map suppliers through:

• Drug product manufacturing site(s) named on the US label and/or in FDA manufacturing listings tied to the approved NDA
• API manufacturer(s) referenced in regulatory submissions and supplier qualification packages
• CDMO roles for tablet compression, film coating, packaging, and quality release testing

Practical US supplier footprint for VIBERZI generally includes:

• Drug product manufacturer(s): IRD/Cambrex manufacturing network (tablets, finished dosage release)
• API supply: specialized small-molecule API providers capable of GMP release for eluxadoline
• Packaging sites: secondary packaging and bottle/blister packaging under GMP controls approved for the NDA

What companies manufacture VIBERZI tablets (eluxadoline) under GMP?

Tablet manufacturing is the critical supplier function for VIBERZI stability, content uniformity, and NDA-validated process controls. Finished dosage strengths are:

• 75 mg tablets
• 100 mg tablets

In the US supply chain, IRD/Cambrex is a recurring manufacturing source for VIBERZI drug product. Contract manufacturers for packaging and distribution are typically separate facilities supporting commercial scale and lot-to-lot release.

What dosage forms and strengths drive supplier qualification?

• Immediate-release tablets: the manufacturing process depends on powder blend uniformity and tablet hardness targets
• Two-strength portfolio (75 mg and 100 mg): suppliers need separate validated batch definitions and in-process controls

Where does eluxadoline API come from: who supplies VIBERZI’s active pharmaceutical ingredient?

API supply is the upstream constraint for any VIBERZI scale-up or generic/authorized-label supplier switch. Eluxadoline requires GMP synthesis, impurity control, and validated analytical methods aligned to the NDA.

Supplier sourcing typically occurs through:

• API manufacturers with established routes for non-peptide, small-molecule oral drugs
• Vendors that can support impurity profiling and stability programs matching NDA specs
• Qualified suppliers listed in drug master files (DMFs) or referenced in regulatory submissions

Which CDMOs can make eluxadoline for VIBERZI supply or licensing?

CDMOs capable of making eluxadoline must support:

• Small-molecule API GMP manufacturing
• Direct compression/tableting-compatible particle size and flow properties
• NDA-aligned analytical release and stability protocols

The most relevant pool is formed by pharma-focused CDMOs with:

• Long-form documentation and batch traceability
• Experience with US FDA submissions and tech transfer packages
• Solid oral dosage manufacturing capacity

In the published supply history for VIBERZI, IRD/Cambrex is a key example of a CDMO-linked manufacturing source for drug product.

What does FDA label information say about VIBERZI manufacturing sites?

The US prescribing information and FDA label details point to a specific commercial manufacturing and packaging chain. Buyers typically reconcile these with:

• FDA “Labeler” data on the package
• NDA manufacturing site details
• Lot release and distribution records

VIBERZI’s marketed supply chain is not “open” in the way commodity generics are. It is constrained by NDA approvals, validated manufacturing processes, and supplier qualification requirements.

How do VIBERZI suppliers affect generic entry and authorized generics?

Supplier availability and manufacturing readiness determine:

• Ability to launch at full strength (75 mg and 100 mg)
• Batch success rates for dissolution, uniformity, and impurity limits
• Speed of tech transfer and analytical method verification

If eluxadoline API or finished-tablet manufacturing capacity is limited, competitors can face:

• Longer tech-transfer timelines
• Higher batch reject risk
• Delayed commercial launch schedules

What Orange Book listings imply about VIBERZI supply and substitution risk?

Orange Book listings affect market entry more than supplier lists do. They define:

• Patent-protected indications and compositions
• When generic substitution becomes possible
• Whether line extensions or formulation changes are protected

For VIBERZI, supplier replacement or generic supply is constrained by patent and exclusivity status tied to the NDA as well as to the manufacturing and analytical equivalence required for FDA approval.

Which suppliers support VIBERZI packaging, distribution, and labeling?

Finished dosage supply includes secondary packaging and label application under GMP:

• Bottling vs blister packaging (depending on commercial channel)
• Labeling with NDA-specific compliance text
• Distribution chain under controlled handling requirements

Packaging suppliers are typically the least visible segment but remain essential for lot release.

What manufacturing/IP barriers limit switching VIBERZI suppliers?

The practical barriers are:

• NDA-validated processes that must be replicated at the new site
• Method transfer for API and finished product testing
• Stability data requirements after tech transfer
• Patent-protected formulation or process claims (where applicable)
• Supply chain compliance requirements tied to controlled labeling and REMS-like prescribing controls (where relevant)

Timeline: how supplier constraints evolve with commercial maturity and entry risk

A typical market maturity pattern:

1. Initial commercialization: concentrated supplier set, faster tech transfer limited by scale constraints
2. Mid-cycle: stable manufacturing lanes, higher QA maturity and lower batch variability
3. Approaching exclusivity/patent windows: competitors seek API and tablet manufacturing capacity early
4. Post-entry: broader supplier options appear for generics only after regulatory and quality alignment

For VIBERZI, the supplier set is tighter than for widely commoditized drugs because API and solid oral manufacturing must match NDA-defined specs at scale.

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Key VIBERZI supplier table (US commercial manufacturing focus)

Supply role	Company / network	Drug scope	Notes
Drug product manufacturing (finished tablets)	IRD / Cambrex	VIBERZI 75 mg and 100 mg tablets	Finishing and GMP release tied to NDA manufacturing records
Upstream API	Specialized eluxadoline API GMP suppliers	Eluxadoline API	API sourcing is typically limited to qualified GMP vendors with impurity control and NDA-aligned analytical specs
Packaging and labeling	NDA-qualified packaging sites	Bottles/blisters	Secondary packaging under GMP and NDA compliance

Key Takeaways

• VIBERZI supply is concentrated around qualified GMP manufacturers, with IRD/Cambrex identified as a key drug product manufacturing source for the finished tablets.
• Eluxadoline API sourcing is an upstream bottleneck because NDA-equivalent impurity control, stability data, and validated methods must transfer to any new supplier.
• Supplier switching is constrained by FDA and NDA process validation needs, plus patent/exclusivity-driven market entry timing rather than by purely commercial contracting.
• Packaging and labeling suppliers are separate qualified nodes that affect lot release and commercial continuity.

FAQs

1. Which company is the manufacturer listed on the VIBERZI US label?
2. Can a generic maker use a different eluxadoline API supplier than the branded NDA holder?
3. What GMP tests most constrain tech transfer for VIBERZI tablets?
4. Do packaging suppliers influence VIBERZI lot release timelines?
5. How early do competitors qualify eluxadoline API and tablet manufacturing ahead of entry?

References

1. FDA. VIBERZI (eluxadoline) prescribing information and label information (accessed via FDA CDER product resources).
2. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for VIBERZI (eluxadoline).
3. FDA CDER drug product and NDA administrative/manufacturing information resources for VIBERZI (accessed via FDA listings).