Suppliers and packagers for CINVANTI

CINVANTI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296	NDA	Heron Therapeutics, Inc.	47426-201-01	1 VIAL, GLASS in 1 CARTON (47426-201-01) / 18 mL in 1 VIAL, GLASS	2018-01-03

CINVANTI (aprepitant) Suppliers: Who Manufactures, Supplies, and Covers Key Drug-Product Inputs

Last updated: June 5, 2026

CINVANTI is marketed as a premixed injectable containing aprepitant. Supplier risk and vendor-selection diligence typically hinges on (1) the manufacturer of the finished dosage form, (2) the upstream suppliers of aprepitant drug substance and critical excipients, and (3) whether a given label configuration (package size, NDC, distribution channel) is tied to specific manufacturing sites.

What companies supply CINVANTI (aprepitant) drug product and finished injections?

CINVANTI is supplied through contract manufacturing and distribution arrangements that map to the finished-goods manufacturer listed on the FDA labeling and its corresponding FDA/Orange Book entries. The most defensible “supplier” list for CINVANTI use cases (procurement, litigation, and generic-risk mapping) is therefore the set of companies that appear as the drug-product manufacturer for the relevant NDC strengths and package configurations.

Where do you find the definitive “finished product” supplier names?

• CINVANTI prescribing information (Drug Product section and/or “Manufactured for” statements).
• FDA Orange Book listings tied to the relevant drug product identifiers (strength and dosage form).
• FDA drug registration and listing records for the specific NDCs and manufacturing sites (CDER registration system).

What supplier categories matter for CINVANTI procurement?

• Finished drug-product manufacturer (terminal aseptic fill-finish and labeling).
• Primary packaging supplier (vials, stoppers, carton/label components).
• Logistics/distribution supplier (cold-chain is typically not the gating factor for CINVANTI, but distribution validation still matters).
• Regulatory-quality contract manufacturers for injection line clearance, fill-finish, and packaging release.

Who supplies CINVANTI drug substance (aprepitant) and how do API sourcing risks show up?

For injectables, API supply continuity drives production scheduling and impacts the feasibility of any generic or “authorized” supply. For CINVANTI, the upstream vendor set is anchored on:

• Apersonal: aprepitant drug substance suppliers that provide commercial bulk API meeting injectable-grade requirements.
• Salt/grade: aprepitant grade specification matching the injectable formulation.
• Quality system: cGMP compliance, DMF/ASMF alignment (where applicable), and audit outcomes.

API supply diligence checklist for CINVANTI

• Traceability of aprepitant to a labeled specification and batch release testing.
• Confirmed DMF/ASMF linkage if used by the reference product or finished-goods applicant.
• Supplier change-control history (site changes, process changes, sterilizing filtration validation).

Which excipient suppliers are critical for CINVANTI injectables?

CINVANTI’s injectable formulation includes aprepitant plus excipients that support solubility and stability in a parenteral format. For vendor-selection and biosupply continuity, excipient supply is often the rate-limiting factor because:

• Parenteral-grade excipients are tightly controlled.
• Some excipients require specialized sourcing and documentation.

Excipients that typically drive injectable supply risk

• Solubilizers and surfactant-like components used to maintain drug substance compatibility in solution.
• Vehicle components that influence viscosity, filtration behavior, and container-closure integrity.
• Sterile-filter compatibility and hold-time performance.

How do CINVANTI NDCs map to different suppliers and manufacturing sites?

A single brand can have multiple NDCs that are tied to different finished-goods manufacturing sites, packagers, or label versions. Supplier lists that mix across NDCs can create avoidable procurement failures.

What to confirm when building a supplier roster

• NDC-level manufacturer name in FDA labeling.
• Manufacturing site address tied to that NDC.
• Labeler/distributor identity versus the actual manufacturer of record.

What suppliers back CINVANTI distribution (wholesalers, specialty distributors)?

“Supplier” is often conflated with “distribution channel.” For CINVANTI:

• Wholesalers and specialty distributors handle inventory and fulfillment.
• The manufacturer of record supplies the wholesalers after batch release.

Distribution mapping that matters

• Contract distribution agreements and lot traceability.
• Hospital/IDN channel coverage versus retail channel coverage.
• Allocation practices during shortages.

What patent and regulatory factors affect supplier options for CINVANTI?

Supplier availability is constrained by regulatory rights and manufacturing know-how:

• Any product manufacturing must be consistent with the approved NDA formulation and manufacturing process controls.
• Patent-protected formulation or manufacturing process know-how can limit alternative suppliers, especially for generics and authorized copies.

Why supplier selection intersects with IP

• A generic supplier must match formulation and meet bioequivalence standards under FDA approval pathways.
• If formulation or method patents exist (including process or packaging/handling), it can constrain route-to-market timelines.

Who are the likely manufacturing supply partners for injectable antiemetics like CINVANTI?

For aprepitant injectable products, the supplier pool in practice often includes:

• Specialized sterile injectable contract manufacturers (CMOs) with aseptic fill-finish capacity.
• Parenteral formulation and fill-finish operators capable of handling oily/solubilized systems (if present in the formulation).
• Primary packaging suppliers qualified for injectable container-closure systems.

This supplier pool is typically selected through:

• NDA/CMC alignment.
• Pre-approval inspections and facility readiness.
• Validation of container-closure integrity and sterility assurance.

Key takeaways

• The most accurate CINVANTI supplier roster is NDC-level and anchored to the FDA-labeled “manufactured for” or manufacturing company of record, plus the corresponding Orange Book/FDA listing.
• Supplier risk concentrates in finished drug-product manufacture (aseptic fill-finish) and in parenteral-grade excipients used to stabilize the formulation.
• Distribution “suppliers” (wholesalers) are operational partners, while true manufacturing suppliers are tied to labeling and FDA listing identities.

FAQs

1) How do I identify the CINVANTI manufacturer of record for a specific NDC?
Use the prescribing information “Manufactured for” section for that specific strength and package, cross-check against the FDA labeler/manufacturer name on the NDC listing.

2) Are CINVANTI suppliers the same across all package sizes?
Not necessarily. Different NDCs can map to different manufacturing sites or packaging contractors, so vendor selection should be NDC-specific.

3) What drives supply risk for CINVANTI injectable production?
Aseptic fill-finish capacity, batch release timelines, and availability of injectable-grade excipients that meet compatibility and stability requirements.

4) Can a generic supplier substitute CINVANTI with the same aprepitant API from any vendor?
No. The API must meet the injectable-grade specification and the finished drug product must be manufactured under an approval pathway consistent with FDA requirements and the protected formulation/process.

5) What documentation should be requested from CINVANTI suppliers during qualification?
Batch CoAs, sterility assurance documentation (as applicable), container-closure integrity evidence, and site cGMP compliance documentation tied to the NDC/manufacturing site.

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. U.S. Food and Drug Administration. Prescribing Information for CINVANTI (aprepitant injectable). Drugs@FDA label content. https://www.accessdata.fda.gov/scripts/cder/daf/