Suppliers and packagers for KINEVAC

KINEVAC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697	NDA	Bracco Diagnostics Inc.	0270-0556-15	10 VIAL in 1 PACKAGE (0270-0556-15) / 5 mL in 1 VIAL	1976-07-21
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697	NDA	Fresenius Kabi USA, LLC	63323-579-05	10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)	2023-04-01

Suppliers and packagers for KINEVAC

Last updated: May 29, 2026

Kinevac (Sincalide) Suppliers: Who Manufactures It, Who Supplies Raw Materials, and What Drives Availability

Kinevac is a U.S.-market brand for sincalide (a synthetic decapeptide cholecystokinin analog) used for gallbladder stimulation. Supplier coverage for Kinevac breaks into two layers: (1) marketing authorizations and finished-dose manufacturing and (2) upstream API and peptide manufacturing for sincali­de supply. The supplier picture is primarily determined by FDA labeling/NDAs plus Orange Book listings (for related patents, not suppliers) and manufacturing site disclosures in FDA submissions.

Result: No supplier list can be produced from the provided input. The question requires identifying (a) the current NDA holder/labeler, (b) the finished-dose manufacturer(s) by site, and (c) API/peptide suppliers (which are often confidential and only inferable from CMC filings, DMFs, or procurement documents). With only “Suppliers for Kinevac,” there is insufficient data to state specific companies.

Who are the manufacturers and labelers for Kinevac (sincalide) finished drug product?

A correct answer requires the FDA labeler (NDA holder) and the listed manufacturers by site for the finished product. For supply planning, the relevant fields are typically: manufacturer name, address/site, and whether the site is for drug substance or drug product.

What must be true to list suppliers: the finished product manufacturer(s) must be stated in the Kinevac FDA label, prescribing information, or FDA databases tied to the specific NDC strength and dosage form.

Which Kinevac dosage forms and NDCs determine the applicable manufacturer?

Supplier attribution can vary by:

• NDC per strength
• presentation (vial configuration, pack size)
• labeling changes after site transfers
• temporary manufacturing during supply disruptions

Without the NDC(s) or the label text used to source the manufacturer list, company naming cannot be made accurately.

What companies supply the sincali­de API (drug substance) for Kinevac?

Upstream supply is usually peptide-manufacturing constrained:

• sincali­de is a synthetic decapeptide, so API supply depends on peptide synthesis and purification capacity
• API suppliers are often registered in the DMF ecosystem, but DMF access is not public for procurement-grade lists

A defensible supplier list requires confirmed linkage between:

• the specific drug substance DMF (or API manufacturer disclosed in FDA review docs) and
• the Kinevac product (NDA) and drug substance specification set

No such linkage can be stated from the provided input.

What is Kinevac’s Orange Book status and does it reveal supplier names?

Orange Book entries typically list:

• active ingredient(s),
• dosage form,
• strength,
• related patents and exclusivity,
• regulatory exclusivity. They do not reliably provide full procurement supplier rosters for the API or the finished-dose manufacturing network.

How does Orange Book information affect supplier mapping?

Orange Book helps with:

• identifying whether there are approved generics or supplemental applications
• mapping the regulatory owner of the product and generic landscape

It does not provide an operational supplier list of API peptide manufacturers.

Which generic or alternative products compete with Kinevac, and who makes them?

Supplier comparison is possible only when specific competitors (generic sincalide injections) are identified. The set of competing NDCs can differ by:

• strength
• package
• labeling indications
• supply continuity

Without competitor identification and NDC mapping, a supplier comparison would risk being inaccurate.

What drives Kinevac supply continuity and supplier substitution risks?

Peptide products tend to face:

• capacity constraints in peptide synthesis and purification
• time-to-qualify changes for sterile filling and packaging
• tight control of peptide identity and purity specifications
• regulatory dependencies tied to process validation and CMC changes

A concrete supplier substitution map still requires named parties from FDA labeling or CMC documentation.

Key Takeaways

• A supplier list cannot be generated from “Kinevac” alone.
• A correct supplier answer requires specific FDA label-derived manufacturer/site data and API linkage.
• Kinevac supplier coverage splits into finished-dose manufacturing and sincalide API peptide supply, and each requires source fields not provided here.

FAQs

1. Is Kinevac manufactured by multiple sites in the US, and how can I verify it? Verification requires the Kinevac label’s manufacturer/site section tied to the specific NDC.
2. Do Kinevac Orange Book patents identify the API or drug product supplier? Orange Book primarily lists patents and exclusivity, not a complete supplier network.
3. Are sincali­de API and sterile drug product manufactured by the same company for Kinevac? Often they are different, but the relationship must be confirmed from label and CMC disclosures.
4. Which FDA filings would contain the API supplier for sincali­de? Typically DMFs and CMC sections tied to the NDA, plus review documents.
5. How do supply disruptions affect who can supply Kinevac? Substitutions usually depend on validated drug product manufacturing capacity and regulatory readiness for site changes.

References

No sources were cited because no verifiable supplier entities for Kinevac were provided or identified in the prompt.