Suppliers and packagers for COMETRIQ

COMETRIQ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756	NDA	Exelixis, Inc.	42388-011-14	4 BLISTER PACK in 1 CARTON (42388-011-14) / 1 KIT in 1 BLISTER PACK	2012-11-29
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756	NDA	Exelixis, Inc.	42388-012-14	4 BLISTER PACK in 1 CARTON (42388-012-14) / 1 KIT in 1 BLISTER PACK	2012-11-29
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756	NDA	Exelixis, Inc.	42388-013-14	4 BLISTER PACK in 1 CARTON (42388-013-14) / 21 CAPSULE in 1 BLISTER PACK	2012-11-29

Suppliers and packagers for COMETRIQ

Last updated: May 30, 2026

Cometriq (cabozantinib) Suppliers: What CDMO, API, and Raw-Material Providers Supply Cabozantinib for Oncology Markets

Cometriq (cabozantinib) supply is dominated by vertically integrated and specialized oncology manufacturers for oral tyrosine kinase inhibitor (TKI) products, with API and key intermediates coming from a small set of global suppliers that support commercial-scale controlled-substance-style controls and low-velocity oncology demand patterns. The practical supplier landscape for Cometriq is best framed by (1) FDA-approved manufacturing sites for drug product and (2) API/intermediate supply points that underpin cabozantinib drug substance and finished-dose production.

This supply map is also shaped by the drug’s ownership and distribution chain, since Cometriq’s FDA-listed manufacturing assignments and later platform shifts (including label changes and supply continuity) determine which vendors can supply for FDA-validated manufacturing slots.

Who manufactures Cometriq drug product (cabozantinib) and which sites are FDA-approved?

Cometriq is an oral capsule product (cabozantinib), so the supplier set is typically limited to CDMOs with proven capabilities in oral solid dose (OSD) manufacturing, including containment controls for potent kinase inhibitors, capsule filling, and stability/packaging systems that match FDA CMC expectations.

Core requirement for qualification: drug product manufacturing must be listed for the approved application in FDA records (Orange Book site data for the specific NDC/strength). Those listings function as the gating mechanism for market supply because they tie manufacturing sites to specific strength, dosage form, and approval.

What to extract from FDA/Orange Book for supplier due diligence

• Drug product manufacturing site(s) listed per NDC/strength
• Applicant/holder of the approved NDA at the time of listing
• Whether multiple sites are listed (dual sourcing)
• Whether supplements added or shifted manufacturing responsibilities over time

Which companies supply cabozantinib (Cometriq) API and key intermediates?

Cabozantinib drug substance supply is the key upstream bottleneck for TKI oral oncology capsules. Even when final dosage is made by multiple CMOs, API and key intermediates typically come from fewer qualified suppliers due to:

• Tight impurity control at low parts-per-million levels typical for kinase inhibitors
• Process validation needs and comparability under FDA CMC rules
• Powder handling containment, solid-state controls, and solvent exposure controls
• Ongoing regulatory scrutiny of cross-site quality systems and deviation histories

Supplier qualification logic used in market practice

• Only API suppliers with established DMF references or directly validated CMC dossiers can reliably support commercial manufacturing
• Site changes require comparability and often additional regulatory work, so procurement tends to lock to approved sources until risk changes

What CDMO capabilities does Cometriq require for capsule manufacturing and packaging?

For Cometriq, the CDMO capability set needed is narrow but strict:

Oral solid dose and potent handling

• Potent compound occupational safety and containment for operator exposure control
• Standardized blending, granulation (if used), drying, capsule filling, and in-process controls
• Powder segregation and carryover prevention to avoid cross-contamination risk

Analytical and release testing

• Validation of HPLC/LC-MS impurity profiles
• Dissolution testing method validation aligned with FDA expectations for cabozantinib capsules
• Stability program and on-going trend reporting for key quality attributes

Packaging and distribution

• Unit-of-use blister or bottle packaging systems that preserve stability
• Serialization is typically not required for all oncology generics-equivalent supply models, but it may apply depending on label/NDC program rules

How does Cometriq’s Orange Book status affect supplier eligibility for generics?

Supplier access for non-originator products is tied to two issues:

1. Orange Book patent listings and exclusivity timing (drives whether suppliers can legally launch)
2. FDA approval of ANDAs and CMC comparability (drives whether suppliers can manufacture for an approved generic or authorized product)

If patents or exclusivities prevent approval, API and finished-dose procurement shifts from “launch-ready” to “option-ready” supply contracts where companies pre-qualify but do not ship to the market.

Which strengths and dosage forms drive the highest supply complexity for Cometriq?

Cometriq is supplied as oral capsules. Supply complexity typically increases with:

• Multiple strength presentations requiring different fill weight control strategies
• Packaging variations by market or label changes
• Any historical manufacturing transitions that create added comparability and stability work

In practice, the supplier base for capsules is constrained by:

• Capsule filling equipment capability
• Blend uniformity risk (cabozantinib dose homogeneity)
• Stability shelf-life targets linked to moisture/oxygen sensitivity

What are the main commercial supply constraints for cabozantinib oral oncology products?

The dominant supply constraints for cabozantinib products, including Cometriq, typically include:

• Single-site or limited-site drug substance availability during process validation cycles
• API impurity excursions risk that triggers batch holds
• Scale-up and changes in synthesis routes that require comparability packages
• QA audit cycles for potent compound handling and data integrity

These constraints create a supplier “lock-in” effect when manufacturing slots are validated and the drug has steady oncology demand.

Which distributors and marketing partners affect where suppliers get paid and how product moves?

Cometriq’s downstream flow includes:

• NDA holder control of U.S. distribution pathways
• Authorized wholesalers and specialty pharmacy distribution for oncology access
• Export channels for non-U.S. markets depending on the label and regulatory status there

From a supplier standpoint, distributor relationships are relevant because they determine:

• Allocation behavior during supply interruptions
• Contracting and forecasting windows for API and finished-dose capacity

How to benchmark Cometriq supply risk by looking at manufacturing site changes and FDA supplements?

Supply risk workstreams usually start with manufacturing assignment history:

• Manufacturing site additions for the approved NDA
• Supplements that shift blending, filling, or packaging responsibilities
• Changes to analytical methods or release specifications that can affect batch disposition timelines

Companies that buy API or contract manufacturing for cabozantinib should track:

• Frequency of CMC supplements
• Number of batch holds and deviation patterns tied to manufacturing sites
• Whether the NDA holder has dual sourcing for drug product and whether API is consolidated

How does Cometriq compare with other cabozantinib brands in supplier ecosystem?

Even when the active ingredient is the same, supplier ecosystems can differ by:

• Regulatory approvals for each brand (site lists differ by NDA)
• Different strengths and dosage forms
• Different packaging and label requirements
• Different payer and distribution structures that influence forecasting and capacity planning

For supplier selection, the relevant comparison is not “cabozantinib overall,” but “cabozantinib for the exact Cometriq NDA product strength and NDC.”

Key Takeaways

• Cometriq supply is constrained by FDA-linked drug product manufacturing site eligibility and by limited qualified upstream cabozantinib API suppliers with proven impurity control and potent handling controls.
• Capsule manufacturing vendors must have validated oral solid dose capability for potent oncology compounds and strong OSD analytics and release testing.
• Supplier due diligence should prioritize FDA site listings per NDC/strength and the company’s track record on CMC supplements, manufacturing deviations, and stability maintenance.
• Downstream distribution and allocation behavior affect procurement planning for both API and finished-dose production.

FAQs

1) How do I identify the exact FDA-listed manufacturers for Cometriq by NDC/strength?
Use the Orange Book listing for the specific NDC/strength and extract the drug product manufacturing site data tied to the approved NDA.

2) What limits the number of cabozantinib API suppliers available for commercial Cometriq production?
Impurity control, DMF/CMC validation, containment and solvent handling requirements, and the effort required for comparability under CMC change rules.

3) Do CDMOs that make other TKIs automatically qualify to make Cometriq capsules?
No. Qualification is project-specific and depends on validated processes, potency controls, analytics, and site approvals tied to the approved NDA.

4) What supplier risks matter most for cabozantinib capsule supply continuity?
API supply interruptions, impurity excursions leading to batch holds, and manufacturing site deviations or CMC supplement delays.

5) How do patent and exclusivity rules influence Cometriq-related supplier planning?
They determine whether ANDA/generic launches can proceed, which affects whether suppliers plan for immediate commercial batches versus longer pre-qualification horizons.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.