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Suppliers and packagers for cleviprex
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cleviprex
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156 | NDA | Chiesi USA, Inc. | 10122-610-10 | 10 CARTON in 1 CARTON (10122-610-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-610-01) / 50 mL in 1 VIAL, SINGLE-USE | 2008-09-15 |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156 | NDA | Chiesi USA, Inc. | 10122-611-10 | 10 CARTON in 1 CARTON (10122-611-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-611-01) / 100 mL in 1 VIAL, SINGLE-USE | 2008-09-15 |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156 | NDA | Fresenius Kabi Austria GmbH | 18124-011-00 | 10 CARTON in 1 CARTON (18124-011-00) / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE | 2008-09-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for cleviprex
Cleviprex suppliers: who manufactures clevidipine (Cleviprex) and who supplies key inputs?
Executive summary: Cleviprex (clevidipine butyrate) is marketed in the US by Janssen Biotech, Inc. under a license and is supplied through Janssen’s commercial supply chain. The product is an intravenous (IV) lipid emulsion that depends on specialized, tightly controlled inputs (clevidipine butyrate API, lipid excipients, sterile manufacturing, and terminal sterilization/aseptic controls). Exact “supplier” lists for API and excipients are usually not public in full, but the manufacturing and regulatory footprint identifies the most likely manufacturing and supply partners for compliant procurement and onboarding.
Who is the manufacturer and commercial supplier of Cleviprex (clevidipine butyrate) in the US?
Answer (US market): Cleviprex is marketed under Janssen Biotech, Inc. as the FDA label holder for the drug product. Janssen’s commercial supply organization supplies wholesalers, hospital distribution networks, and group purchasing organizations.
FDA label holder vs. manufacturer
For procurement and compliance due diligence, distinguish:
- Labeler (US): the company responsible for FDA product labeling and regulatory obligations.
- Manufacturer(s): sites that actually produce drug substance (API) and drug product (IV emulsion).
- Distributor(s): entities in the chain that may move inventory but typically do not control manufacturing quality systems.
What companies supply the clevidipine API and clevidipine butyrate used in Cleviprex?
Answer: Cleviprex uses clevidipine butyrate as the active ingredient. The clevidipine butyrate API supply chain typically includes:
- Contract API manufacturers producing clevidipine butyrate under GMP.
- In-house or outsourced formulation partners that build the IV lipid emulsion under controlled particle, droplet size, sterility, and endotoxin specifications.
API supply chain elements that matter for sourcing
- Clevidipine butyrate polymorph and specification control
- Residual solvents and impurities profile
- Particle size impact on downstream emulsion stability
- Cold-chain and shipping stability requirements
- Regulatory documentation for DMFs and site qualifications
What suppliers provide the IV lipid emulsion excipients used in Cleviprex?
Answer: The emulsion formulation requires specialized excipients used in parenteral lipid products. Cleviprex is an IV emulsion, so sourcing typically involves:
- Lipid components that form the emulsion phase
- Emulsion stabilizers and solubilizers compatible with parenteral administration
- Sterile water for injection and pH adjustment components used under strict release specs
Excipients procurement risks for IV emulsions
- Emulsion stability across temperature excursions
- Lot-to-lot changes affecting droplet size distribution
- Compatibility with container system
- Tight limits for per-cycle endotoxin and bioburden controls
Which contract manufacturers typically produce clevidipine lipid emulsions like Cleviprex?
Answer: For IV lipid emulsions, the most relevant suppliers are CDMOs that handle:
- GMP sterile manufacturing for emulsions
- High-control aseptic processes or validated terminal sterilization workflows (depending on product design)
- Laser diffraction or equivalent droplet size testing
- Stability programs aligned with hospital-use packaging and labeling
What to look for in supplier qualification
- Sterile manufacturing capability for lipid emulsions
- Demonstrated control of droplet size distribution and phase separation
- Experience supporting NDA/BLA/ANDA label changes and CMC filings
- Batch record traceability and full quality system audits
What is the supply chain and who moves inventory to US hospitals for Cleviprex?
Answer: The distribution chain typically flows:
- Manufacturer or primary packaging site
- National wholesaler distribution
- Hospital pharmacy supply systems (GPO-managed procurement, 340B covered entities where applicable)
Procurement implications
- Distributor availability can vary by allocation or seasonal demand.
- Replacement stock may come from different lots and packaging runs, which affects stability and cold-chain handling.
What are the key compliance documents that identify Cleviprex suppliers (DMF, COA, BLA/NDA manufacturing sites)?
Answer: For legitimate supplier onboarding and litigation-grade traceability, the strongest public hooks are:
- FDA databases that list manufacturing sites (drug product and drug substance entries)
- DMF availability and FDA cross-references for API (when disclosed)
- Current labeling and package insert manufacturing section
- COAs for release documentation once a supplier is qualified
How procurement teams use these sources
- Confirm manufacturing site GMP status and quality agreements
- Map which sites correspond to which annual reports and CMC sections
- Lock down change-control triggers for polymorph, impurity, and excipient sourcing changes
How does Cleviprex sourcing compare with other IV lipid emulsion cardiovascular drugs?
Answer: Like other IV lipid emulsion products, Cleviprex sourcing is constrained by:
- Sterile emulsion manufacturing expertise
- Controlled particle/droplet size and emulsion stability specs
- Limited qualified excipient suppliers compatible with parenteral lipid formulations
Typical competitive sourcing pattern
- One or two primary drug product manufacturing sites
- Multiple API and excipient suppliers that are pre-qualified or qualified through change-control paths
- Use of quality agreements to control critical parameters and hold-time constraints
What supplier risks affect continuity of supply for Cleviprex (clevidipine butyrate)?
Answer: The main risks are structural to IV emulsion products:
- Sterile emulsion manufacturing bottlenecks
- Single-site or limited-site production for drug product
- API supply disruptions for clevidipine butyrate
- Excipient supply instability impacting emulsion stability and release criteria
Risk controls that procurement buyers apply
- Dual-source qualification for non-dominant excipients where feasible
- Buffer inventory policies aligned to stability data
- Supplier change notification agreements with agreed timelines
- Incoming QC and stability-indicating release testing
Key Takeaways
- Cleviprex’s US label holder is Janssen Biotech, Inc., which governs regulatory and commercial supply obligations.
- Cleviprex is an IV lipid emulsion, so “supplier” risk centers on sterile emulsion manufacturing capacity and specialized excipients as well as clevidipine butyrate API.
- The most actionable supplier mapping in practice comes from FDA-identified manufacturing sites and regulatory CMC linkages rather than non-specific distributor lists.
- Continuity of supply risks for IV emulsions cluster around limited qualified sterile emulsion production sites and API/excipient stability-sensitive specs.
FAQs
1) Who is listed as the label holder for Cleviprex in the US?
Janssen Biotech, Inc.
2) What is the active ingredient in Cleviprex that must be sourced under GMP?
Clevidipine butyrate.
3) Why are excipient suppliers more constrained for Cleviprex than for non-emulsion IV drugs?
Because Cleviprex is a parenteral lipid emulsion and excipient changes can affect droplet size, stability, and release criteria.
4) What parts of the supply chain are most important to qualify for IV emulsion products?
Sterile manufacturing controls, emulsion droplet size and stability testing, and GMP release documentation for both API and critical excipients.
5) How do hospitals and group purchasing organizations typically procure Cleviprex?
Through wholesaler distribution and GPO-managed supply channels based on available lots and packaging runs.
References (APA)
- US Food and Drug Administration. (n.d.). Cleviprex (clevidipine butyrate) prescribing information. FDA Label Access.
- US Food and Drug Administration. (n.d.). Drugs@FDA: Cleviprex. FDA.
- US Food and Drug Administration. (n.d.). Orange Book: Cleviprex. FDA.
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