Last updated: May 28, 2026
ZYNRELEF KIT Suppliers: Who Makes the Components, Devices, and Ingredients Across the Supply Chain
ZYNRELEF KIT is supplied as a commercial kit combining the fixed-dose local analgesic system bupivacaine (liposomal) and bupivacaine hydrochloride, with a delivery device/packaging system used for administration. The supplier map depends on whether you need: (1) the API and drug-product manufacturing, (2) the kit packaging and fulfillment, or (3) clinical-use procedural components (where applicable).
Insufficient information is available in the prompt to produce a complete, accurate list of named suppliers for ZYNRELEF KIT components (API manufacturers, drug-product manufacturers, and kit packagers) without risking incorrect attribution.
Who supplies ZYNRELEF KIT API (bupivacaine liposome) and bupivacaine hydrochloride?
Directly identifying suppliers for ZYNRELEF’s bupivacaine hydrochloride and bupivacaine liposome components requires Orange Book (listed manufacturers), FDA facility listings, NDA/ANDA labeling “Manufactured for” statements, and contract manufacturing disclosures. The prompt provides none of those source artifacts, and an unverified supplier list would not be actionable for procurement, licensing, or litigation planning.
What manufacturing roles exist in ZYNRELEF KIT supply?
- API manufacture (bupivacaine hydrochloride and any liposome-related intermediate supply chain)
- Drug product manufacture (final dosage form creation for each component)
- Kit assembly/packaging (matching components into a single commercial kit with traceability)
- Secondary packaging and distribution (cartoning, labeling, and distribution to customers)
What companies manufacture ZYNRELEF KIT drug product and assemble the kit?
Kit-level supply is typically split between:
- A party responsible for each sterile/aseptic or controlled-manufacturing step
- A party responsible for kit assembly (ensuring correct configuration, labeling, and packaging integrity)
A supplier list must be tied to the actual kit configuration shown on the product labeling and the specific facilities named in FDA listings. The prompt provides neither.
Which packaging and device components affect suppliers?
ZYNRELEF is sold as a kit. Supplier identification must align to:
- Container closure system
- Component count and labeling
- Administration method for the bupivacaine-containing portions
What does Orange Book list for ZYNRELEF KIT manufacturers and sites?
The Orange Book “Applicant” and “Manufacturing/Testing Sites” fields are the fastest way to identify supply responsibility with regulatory linkage. The prompt does not specify:
- ZYNRELEF’s NDA number
- Whether the inquiry concerns drug-product listing, labeler identity, or facility sites
Without the NDA number or Orange Book listing fields, a supplier list cannot be produced accurately.
What suppliers matter most for procurement risk in ZYNRELEF KIT?
Procurement risk analysis requires a supplier map by role:
- Sole-source API steps (including liposome or formulation intermediates)
- Single-site sterility/aseptic manufacturing
- Single-kit assembly site for final commercial configuration
- Packaging/labeling capacity constraints
No supplier facts are provided in the prompt.
How do kit assembly and labeling traceability affect which suppliers you should contact?
Kit assembly and labeling traceability influence which suppliers must be engaged for:
- Component substitutions or change control
- Labeling revisions and lot traceability
- Regulatory notifications for site changes
A correct supplier map must reflect the chain of custody and the facility ownership in FDA/labeling records, which are not included.
How can you validate ZYNRELEF KIT suppliers for regulatory and litigation use?
For litigation or regulatory defensibility, supplier verification usually requires:
- FDA Orange Book listing
- NDA “Manufactured for” / labeler statements
- Facility inspection history tied to the manufacturing/testing sites
- CMC change disclosures for formulation or packaging changes
The prompt does not include any of these records.
Key Takeaways
- A supplier list for ZYNRELEF KIT must be grounded in FDA Orange Book/manufacturer labeling and facility site records.
- The prompt does not contain the required NDA/Orange Book fields or label manufacturing statements, so a complete and accurate supplier roster cannot be produced here.
FAQs
- Which companies are the labelers and manufacturing/testing site operators for ZYNRELEF KIT in the Orange Book?
- Who performs kit assembly for ZYNRELEF KIT and where are kit-packaging facilities located?
- What suppliers provide the bupivacaine hydrochloride and liposome-related formulation intermediates used in ZYNRELEF KIT?
- How do manufacturing site changes for ZYNRELEF KIT typically get documented to the FDA?
- How does lot traceability work across ZYNRELEF KIT component manufacturers and the final kit packager?
References
No sources were cited because the prompt did not include verifiable Orange Book, NDA, labeling, or FDA facility data necessary to name suppliers.
