Suppliers and packagers for exparel

exparel

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496	NDA	Pacira Pharmaceuticals, Inc.	65250-133-04	4 VIAL in 1 CARTON (65250-133-04) / 10 mL in 1 VIAL (65250-133-10)	2016-01-01
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496	NDA	Pacira Pharmaceuticals, Inc.	65250-133-09	10 VIAL in 1 CARTON (65250-133-09) / 10 mL in 1 VIAL (65250-133-10)	2016-01-01
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496	NDA	Pacira Pharmaceuticals, Inc.	65250-266-04	4 VIAL in 1 CARTON (65250-266-04) / 20 mL in 1 VIAL (65250-266-20)	2012-01-01
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496	NDA	Pacira Pharmaceuticals, Inc.	65250-266-09	10 VIAL in 1 CARTON (65250-266-09) / 20 mL in 1 VIAL (65250-266-20)	2012-01-01

Suppliers and packagers for exparel

Last updated: May 31, 2026

Who supplies Exparel (bupivacaine liposome injectable suspension)? Key manufacturers, sourcing risks, and FDA-grade supply chain

Exparel is a branded injectable product of bupivacaine liposome suspension (1.3%). Its commercial supply chain centers on the manufacturing and packaging network for the injectable drug product and the production of drug substance and liposome components. The controlling parties are the NDA holder and the listed contract manufacturers that produce and package Exparel for U.S. distribution, as reflected in FDA product labeling and FDA regulatory filings and in the Orange Book where applicable.

What companies supply Exparel to the US market? Who manufactures the finished drug product?

Exparel’s U.S. distribution is tied to the NDA holder and the contract manufacturing sites used for drug product manufacturing, filling, and packaging under cGMP. In practice, “suppliers” splits into (1) NDA holder-controlled manufacturing, (2) contract manufacturers for sterile drug product filling, and (3) component suppliers for liposome and bupivacaine-based inputs.

Core supply roles in Exparel’s manufacturing chain

• NDA holder and regulatory owner: The party that holds marketing authorization and controls tech transfer, validation strategy, and post-approval manufacturing changes.
• Sterile injectable drug product manufacturer(s): Site(s) performing aseptic processing, filling, and packaging for U.S. distribution.
• Drug substance and liposome component suppliers: Input suppliers feeding raw materials, lipid components (for liposomes), and validated intermediates that meet cGMP specifications.
• Secondary packaging and logistics providers: Labeling, carton/kit configuration where used, and distribution logistics.

What must be verified for a sourcing decision

For procurement, contracting, or IP risk mapping, Exparel “supplier” identification should be based on:

• FDA labeling “Manufactured for/By” and “Distributed by” language
• FDA CMC supplements that disclose manufacturing site changes
• FDA facility registrant information (for manufacturing and packaging steps)
• Orange Book listing tied to the NDA for Exparel (active ingredient and dosage form)

What does the Exparel Orange Book list about manufacturers and protected product changes?

The Orange Book is the anchor for the NDA-level product identity and patent coverage tied to Exparel. It is not a supplier directory, but it helps map which NDA supplement structure exists and which product attributes have patent hooks. Those attributes often correlate with CMC manufacturing constraints that limit alternate sourcing.

How Orange Book data affects “supply”

• Patent estate links to formulation/manufacturing controls: Any change in liposome composition or structure can trigger CMC comparability work and regulatory submissions. That can narrow the list of qualified suppliers.
• NDA-level continuity: If Exparel is maintained through multiple manufacturing site changes, the Orange Book will still maintain a consistent product listing even as manufacturing network evolves.

What FDA regulatory status does Exparel have that shapes supply chain constraints?

Exparel is an FDA-approved injectable product containing bupivacaine in a liposome-based extended-release format. Its regulatory posture affects supplier qualification because the drug is sterile, injectable, and requires validated release testing for drug product performance and sterility assurance.

Key supply-chain constraints driven by FDA requirements

• Sterility assurance and aseptic processing controls
• Release testing consistency for liposome properties
• Stability-indicating assays for extended-release behavior
• Container-closure system validation (syringe/vial configuration, if applicable)

How many manufacturing sites supply Exparel and what are the common bottlenecks?

The number of qualified supply sites is determined by regulatory approvals for manufacturing and packaging. Common bottlenecks in long-acting liposome injectables include:

• Limited qualified sterile manufacturing lines capable of aseptic handling
• Specialized equipment for liposome processing and controlled particle-size or lamellarity targets
• Tight raw material specifications for lipid components and intermediates
• Batch-to-batch consistency requirements that make tech transfer complex

Which contract manufacturers typically handle sterile filling for liposome injectables like Exparel?

For liposome injectables, the “supplier” question usually ends up being a sterile fill-finish question. The key procurement point is whether Exparel’s fill-finish is performed by:

• a dedicated sterile injectable contract manufacturing organization (CMO) with liposome handling experience, and
• a finished goods packaging line approved for the exact container-closure system.

That determination must be made from Exparel’s current FDA labeling/manufacturer statement and any disclosed site changes in regulatory submissions.

What formulations and presentations are supplied for Exparel (dose strengths, container types)?

Exparel is supplied as bupivacaine liposome injectable suspension. The procurement relevance is that each presentation (vial/syringe, kit configuration) requires its own validated manufacturing and packaging run.

Presentation-driven supply planning

• Lead times differ by presentation due to packaging line scheduling
• Any packaging configuration change can require regulatory notification or approval
• Labeling components (cartons, inserts) are separately contracted and can become the constraint

What generic entry risks exist for Exparel that could disrupt or expand supply?

Generic entry is constrained by Exparel’s formulation and extended-release delivery system. Competitors face:

• Product sameness hurdles for complex liposome characteristics
• Sterile injectable process validation requirements
• Performance equivalence expectations under FDA review

For any “supplier” expansion scenario, generic launches generally add capacity only if:

• FDA approves a sufficiently similar product, and
• at least one alternate fill-finish/packaging network can meet release and stability requirements at scale.

What patent estate issues affect supply continuity and alternative manufacturing?

Exparel’s patent landscape can affect “supply” indirectly by limiting legitimate manufacturing pathways for alternative versions or by restricting certain formulation or method-of-use embodiments. When patents cover key composition or manufacturing steps, it can deter “authorized” supply shifts and slow down generic or follow-on competition.

Practical impact on sourcing

• Authorized supply expansions tend to rely on the brand NDA holder’s approved manufacturing network
• Generic/follow-on supply is delayed by formulation and regulatory acceptance, not only by patent expiry

Key suppliers and CMO names for Exparel: what is directly confirmable

No verified Exparel supplier list can be produced here without introducing errors. Supplier names must come from current, authoritative evidence such as the Exparel prescribing information “Manufactured for/By” or “Distributed by” text or current FDA facility listing tied to the NDA. Without those direct citations, publishing company names would be unreliable.

Key Takeaways

• Exparel’s “suppliers” are best defined as (1) the NDA holder and (2) the contract sterile injectables manufacturer(s) plus packaging operations shown in current FDA labeling and regulatory filings.
• The manufacturing bottlenecks for Exparel are typically sterile fill-finish capacity, liposome process controls, and validated release testing for extended-release properties.
• Patent and CMC constraints limit legitimate alternative sourcing and slow supply expansion from generics unless formulation equivalence is accepted by FDA.
• A sourcing decision for Exparel should be anchored to the current prescribing information manufacturer/distributor statements and the FDA manufacturing disclosure for the NDA.

FAQs

1. Which companies hold the Exparel NDA and control manufacturing changes?
2. What contract manufacturers are listed on Exparel labeling for aseptic filling and packaging?
3. How does Exparel’s liposome formulation affect the ability of a new CMO to qualify as a supplier?
4. What timelines matter most for Exparel supply expansion tied to generic or follow-on approval?
5. Does Exparel’s patent estate restrict contract manufacturing of similar liposome bupivacaine products?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book).
2. U.S. Food and Drug Administration. Drugs@FDA: Exparel.
3. Exparel prescribing information (current FDA-approved label).