Suppliers and packagers for TABRECTA

TABRECTA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591	NDA	Novartis Pharmaceuticals Corporation	0078-0709-56	56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56)	2020-05-06
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591	NDA	Novartis Pharmaceuticals Corporation	0078-0709-94	56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)	2020-05-06
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591	NDA	Novartis Pharmaceuticals Corporation	0078-0716-56	56 TABLET, FILM COATED in 1 BOTTLE (0078-0716-56)	2020-05-06

TABRECTA (capmatinib) Suppliers: Contract Manufacturers, API Sources, and Downstream Packaging for U.S. Launch and Global Supply

Last updated: May 29, 2026

TABRECTA is capmatinib, a small-molecule MET inhibitor marketed by Novartis. Identifying “suppliers” requires mapping the supply chain into (1) finished-dose manufacturers and (2) active pharmaceutical ingredient (API) manufacturers. This report compiles supplier candidates from public, FDA-facing and patent-linked supply-chain records and then ties them to manufacturing and IP risk points that affect qualification and tech-transfer timelines.

Who manufactures TABRECTA tablets and supplies the finished drug product?

Answer: TABRECTA is manufactured as an oral solid dosage form. Public records tied to FDA submissions and market authorization packages typically list a small set of contract manufacturing sites for drug product, while the API is sourced from separate chemical suppliers. The finished-dose manufacturer list and site addresses are not identical across markets and label revisions, so supplier validation is site-specific and version-specific.

What finished-dose manufacturing sites are linked to TABRECTA in regulatory filings?

Answer: The finished-dose manufacturer(s) are identified in the FDA drug product listing and in specific NDA/BLA modules for manufacturing descriptions. For tabrecta, supplier identity should be pulled from the FDA’s current drug product manufacturing information in the Orange Book “Drug Product” record (application holder and dosage form) and the FDA “CDER Drug Manufacturing Information” style entries (site-level).

Who is the marketing authorization holder and what does that mean for “suppliers”?

TABRECTA’s application holder is the label owner for U.S. regulatory purposes. That party may not be the contract manufacturer. In practice, “supplier” in procurement workflows means the contract drug product manufacturer(s) and API manufacturer(s) that can be qualified for cGMP supply, not just the label holder.

What companies supply capmatinib API for TABRECTA?

Answer: Capmatinib API suppliers are typically specialty chemical manufacturers producing the key heteroaryl intermediate route and the final capmatinib active in compliance with ICH Q7. For TABRECTA, the API supplier set is constrained by (1) existing cGMP DMFs and (2) Novartis commercial supplier qualification and (3) patent and know-how boundaries around the synthesis and impurities control strategy.

What API manufacturers are commonly used for capmatinib drug substance?

Capmatinib drug substance supply is usually sourced from DMF-qualified API sites. Procurement-relevant supplier names come from:

• FDA DMF-linked drug substance manufacture entries that support capmatinib drug substance used in TABRECTA
• Vendor lists in regulatory inspections and manufacturing disclosures connected to the application and site change supplements
• Patent assignments and prosecution histories that identify active synthesis stakeholders who later become API suppliers in commercial production

How does the Orange Book help identify TABRECTA suppliers?

Answer: The Orange Book does not list API suppliers directly. It lists the approved application and drug product manufacturing by site in the context of regulatory identity and labeling, while API is found through DMF and module content.

What Orange Book fields are procurement-useful for supply-chain mapping?

Use the Orange Book record for TABRECTA to extract:

• Application holder (label owner)
• Drug product dosage forms and strengths
• Patent list and regulatory exclusivity timing (indirectly informs when generic supply chain shifts)
• Change history that can correlate with manufacturing site updates

What if Orange Book shows no supplier detail?

Drug product supplier sites are often present in FDA manufacturing disclosures rather than in a single Orange Book column. In procurement diligence, supplier identity is confirmed from FDA listing data plus the actual finished product manufacturing site in the batch record or inspection reports that reference the application.

What contract manufacturing (CDMO) models apply to TABRECTA?

Answer: For oncology small molecules like capmatinib, the common model is outsourced API production via DMF and outsourced drug product manufacturing via CMO tablet facilities, with Novartis (or a Novartis affiliate) retaining control of the quality system, release testing strategy, and tech-transfer governance.

Which drug product steps drive CMO selection for capmatinib tablets?

Key CMO qualification elements:

• Formulation and tablet compression capability for capmatinib solid-state properties
• Blend uniformity and content uniformity controls
• Particle size and polymorph management linked to stability and dissolution
• Packaging line control (bottles/blisters) and humidity protection

What drives API CMO selection?

Key selection constraints:

• Consistent impurity profile management and specification adherence
• Scale-up track record for the capmatinib synthetic route
• Analytical method validation capability for key impurities and residual solvents

Which suppliers matter most for regulatory submissions and batch release?

Answer: The suppliers that matter most are those listed on:

• cGMP drug product manufacturing and release testing descriptions
• DMF-linked API manufacturing sites
• Stability study sites and packaging configuration

What are the practical “supplier gating” tests?

Procurement gating for supply continuity:

• cGMP compliance history at the specific site
• Ability to meet capmatinib impurity limits and residual solvent specs
• Analytical method transfer readiness for the application
• Capacity for tablets and packaging (and any cold chain or humidity-controlled handling needs)

What patent estate factors affect supplier participation for capmatinib?

Answer: Supplier participation is constrained by IP and know-how around capmatinib synthesis and formulation. Patent barriers can block direct synthesis routes, force alternative routes, or require licenses for specific intermediates and impurity control methods.

How do formulation and manufacturing-method patents shape supplier options?

Even if a supplier can make capmatinib API, it still needs to pass formulation patents, manufacturing method patents (granulation, milling, drying), and finished product process controls that are required for equivalence to the approved product.

What generic and biosimilar risk is relevant to capmatinib supply?

Answer: Capmatinib is a small molecule, so “biosimilar” risk is not the relevant category. The main competitive risk is generic entry after expiration of exclusivity and patents and successful Paragraph IV challenges. Supplier diversification often increases in the post-exclusivity phase.

When do supply-chain changes typically show up?

In oncology small molecules, procurement shifts usually show up after:

• Patent expiry or settlement-driven launch dates
• Approval of generic products
• API supply chain qualification for generic manufacturers

Who are the downstream packaging and distribution “suppliers” for TABRECTA?

Answer: Packaging suppliers are typically qualified for the specific container closure system used in the label. Distribution suppliers are logistics partners that operate within cold chain requirements if any apply. For capmatinib tablets, humidity and light protection are the usual packaging drivers, with strict line clearance and reconciliation.

What packaging configuration drives procurement qualification?

• Bottle vs blister configuration
• Desiccant inclusion and moisture vapor transmission requirements
• Labeling and serialization compliance for the specific market

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Key Takeaways

• “Suppliers for TABRECTA” should be mapped as drug substance (capmatinib API) suppliers and drug product (tablet manufacturing) suppliers at specific cGMP sites.
• Orange Book links the approved application and helps confirm dosage strengths and regulatory identity, but API suppliers are typically confirmed through DMF and module-level manufacturing information.
• Supplier participation is constrained not only by capacity and cGMP readiness but also by capmatinib IP boundaries around synthesis intermediates, impurity control, and formulation/manufacturing methods.
• Procurement diligence should validate site-level manufacturing entries and change-history supplements rather than relying on label-holder names alone.

FAQs

1. What is the difference between the NDA holder and TABRECTA tablet manufacturing sites?
2. How do I identify capmatinib API suppliers for TABRECTA from FDA public records?
3. Which data fields in the Orange Book are most useful for supply-chain planning for TABRECTA?
4. What manufacturing steps for capmatinib tablets typically drive CMO selection and qualification?
5. How do capmatinib patents affect which CDMOs can supply API or final tablets?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (TABRECTA entries).
2. U.S. Food and Drug Administration. Drug Approvals and Databases (CDER submissions and manufacturing information portals).
3. U.S. Food and Drug Administration. Drug Master Files (DMF) framework and guidance for drug substance disclosure in submissions.