KISQALI: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0860-01	1 BLISTER PACK in 1 CARTON (0078-0860-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK	2017-03-13
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0867-42	3 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)	2017-03-13
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092	NDA	Novartis Pharmaceuticals Corporation	0078-0874-63	3 BLISTER PACK in 1 CARTON (0078-0874-63) / 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21)	2017-03-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 28, 2026

KISQALI Suppliers: Who Manufactures Kisqali (Ribociclib) and What Inputs Matter

KISQALI (ribociclib) is marketed in the US by Novartis. The drug is manufactured through a global supply chain that includes Novartis affiliates and contract manufacturing organizations (CMOs) for drug substance (API) and drug product (tablets). KISQALI’s supplier landscape is dominated by Novartis-controlled manufacturing plus regulated third-party manufacturers listed in regulatory filings.

Who supplies the ribociclib API used to make KISQALI?

KISQALI uses ribociclib as the active pharmaceutical ingredient. In practice, ribociclib API supply is handled by (1) Novartis manufacturing sites and (2) approved contract manufacturers whose identities appear in Drug Master Files (DMFs) and quality sections of regulatory dossiers.

What companies typically appear as ribociclib API suppliers for branded KISQALI?

Novartis manufacturing network: primary source for commercial supply for many geographies.
DMF-listed manufacturers: API manufacturers referenced by Novartis in marketing applications or associated DMFs.

Key point: The full set of API suppliers is not determinable from “supplier” searches alone because the legal and regulatory record is spread across DMFs and site lists; the authoritative supplier list is the one embedded in FDA application quality modules and global regulatory submissions.

Which companies supply the KISQALI tablets (drug product manufacturing)?

KISQALI is a finished-dose tablet product. Tablet manufacturing is typically performed by Novartis sites and/or CMOs under commercial-quality oversight, with specific manufacturing sites identified in regulatory product information and label/registration documentation.

What manufacturing roles do KISQALI “suppliers” include?

Finished-dose tablet manufacturing (compression, coating, packaging)
Blending and granulation (where applicable to tablet process design)
Packaging (bottle, blister, unit dose packaging)
Quality release testing (impurities, dissolution, assay, stability)

Key point: “Supplier” in commercial terms usually means both the manufacturer and the quality release entity, which can differ from marketing authorization holders.

What contract manufacturing organizations (CMOs) make KISQALI under Novartis?

CMO involvement is common for commercial solid oral dosage supply chains. The identity of specific CMOs depends on:

geography,
product configuration (strength and pack format),
and the period of commercial supply.

How to interpret KISQALI manufacturing supplier listings

If listed in FDA product registrations or label manufacturing sections, it indicates the site that performed manufacturing and/or packaging for US distribution.
If listed only in DMFs, it indicates API supply chain involvement rather than finished-dose tablet manufacturing.

What sources of information list KISQALI suppliers reliably?

The most defensible supplier list for KISQALI comes from regulatory and quality documentation, not from generic procurement catalogs.

Authoritative sources

FDA drug application quality sections (where site-specific manufacturing and controls are described)
FDA registrations and listings (establishment details for manufacturing and processing)
Orange Book entries and associated submission data (for product context, not always site-by-site)
DMFs for ribociclib API (site-specific)

Supplier risk: What breaks KISQALI supply and who is impacted first?

KISQALI supply risk is concentrated in:

API availability (raw material procurement, synthesis steps, intermediate supply),
GMP capacity (tablet manufacturing slots),
quality release testing capacity.

Where shortages usually originate in branded oncology small molecules

API bottlenecks due to synthesis complexity and limited multi-step capacity.
GMP batch release bottlenecks due to analytical workload and stability commitments.
Packaging constraints tied to blister/bottle supply and labeling.

Key point: If ribociclib API supply tightens, tableting and packaging sites can become idle despite being operational.

KISQALI supply chain compared with competing CDK4/6 inhibitors: does ribociclib sourcing differ?

CDK4/6 inhibitor oncology brands (palbociclib, abemaciclib, ribociclib) each have distinct API chemistries and sourcing networks. Supply chain configuration differences usually show up in:

number of qualified API sites,
availability of alternative synthetic routes,
and how many tablet manufacturing sites can support surge demand.

What that means for procurement

Higher substitution risk is typical when fewer qualified API manufacturers exist.
Faster substitution usually exists when multiple API DMFs are already approved and transferable within quality systems.

Which KISQALI supply partners are used for global markets?

Global supply often uses:

regional CMO/affiliate tablet sites,
centralized API manufacture with regional drug product conversion,
and packaging tailored to regional labeling requirements.

Market-driven variation

pack format (bottles vs blisters)
local labeling and translation requirements
distribution center-specific packaging specs

What procurement categories exist for KISQALI “suppliers”?

Procurement teams often segment suppliers by functional category:

API producers (ribociclib)
Excipient and intermediate suppliers (used in synthesis and formulation)
Tablet manufacturing CMOs (solid oral dosage)
Packaging vendors (bottles, blister foils, cartons, leaflets)
Testing/analytical release labs (in-house or contracted)

Key Takeaways

KISQALI is supplied through a Novartis-led network combining Novartis manufacturing sites and approved third-party manufacturers for API and finished-dose tablets.
The most reliable supplier identities come from FDA quality documentation (DMFs) and manufacturing site listings tied to US distribution.
Supplier risk is highest at the API step due to constrained chemistry capacity and multi-step synthesis dependencies.

FAQs

How can I verify the API manufacturer for ribociclib used in KISQALI?
Use FDA quality documentation and DMF-referenced manufacturing sites tied to the approved application.
Do KISQALI tablet manufacturing sites differ by strength or packaging format?
They can, because regulatory release is tied to specific manufacturing and packaging configurations.
Who qualifies suppliers for oncology small-molecule APIs like ribociclib?
Quality systems qualify API sites via comparability, validation, and GMP compliance aligned with the marketing authorization.
What are the most common causes of KISQALI supply disruptions?
API synthesis bottlenecks, GMP capacity constraints, and analytical release testing delays.
Can a CMO that makes tablets also supply packaged product for KISQALI?
Yes, if it holds the required GMP activities for packaging and labeling under the authorization.

References (APA)

U.S. Food and Drug Administration. (n.d.). Drug establishments and FDA registration and listing resources. https://www.fda.gov/industry/fda-eservices
U.S. Food and Drug Administration. (n.d.). Drug databases and labeling resources for authorized drug products. https://www.accessdata.fda.gov
FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

Suppliers and packagers for KISQALI

KISQALI