Suppliers and packagers for QINLOCK

QINLOCK

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973	NDA	Deciphera Pharmaceuticals, LLC	73207-101-30	1 BOTTLE in 1 CARTON (73207-101-30) / 90 TABLET in 1 BOTTLE	2020-05-15
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973	NDA	Deciphera Pharmaceuticals, LLC	73207-101-31	1 BOTTLE in 1 CARTON (73207-101-31) / 30 TABLET in 1 BOTTLE	2020-05-15

Suppliers and packagers for QINLOCK

Last updated: June 1, 2026

QINLOCK (Ripretinib) Suppliers: Who Manufactures Drug Substance, Finished Dosage, and Key Packaging

Executive summary: QINLOCK (ripretinib) supply is concentrated in a small number of contract manufacturing and packaging roles tied to Novartis’s lifecycle management. The practical supplier set for day-to-day market supply is (1) the drug-substance supply chain for ripretinib, (2) tablet manufacturing for the 50 mg regimen, and (3) finished-goods packaging and distribution. This supplier map is traceable through public FDA facility listings, NDA/BLA manufacturing site disclosures, and Orange Book-labeled information for QINLOCK’s approved dosage forms.

Who are the pharmaceutical suppliers manufacturing QINLOCK (ripretinib) tablets?

Short answer (featured-snippet style): QINLOCK tablets are produced at registered FDA-listed manufacturing facilities for the drug product (tablets) and at separate registered facilities for drug substance and packaging, with Novartis as the NDA holder and responsible for GMP release.

What facility roles typically exist in the QINLOCK supply chain

QINLOCK distribution depends on three functional supplier categories:

• Drug substance (API) manufacturers: produce ripretinib drug substance under GMP and supply intermediate grades to the tablet manufacturing sites.
• Drug product manufacturers: formulate, compress, coat (if applicable), and package tablets into the approved dosage form.
• Packaging and label suppliers: perform bulk-to-final packaging steps (bottles, cartons, labels) and may include additional contract sites for serialization or country-specific labeling.

Where to verify QINLOCK suppliers

High-confidence supplier identification is done through:

• FDA “Drugs@FDA” product and labeling pages for QINLOCK
• FDA SPL manufacturing site information tied to the approved NDA
• Orange Book listing pages for dosage form-specific details where available
• FDA establishment registration databases for the specific facility names tied to QINLOCK manufacture and release

What does the FDA Orange Book list as QINLOCK drug product manufacturing sites?

Short answer: Orange Book primarily lists patent and exclusivity information, but the listing is linked to the approved dosage forms and can be cross-referenced to the NDA and FDA SPL records that contain manufacturer and packer facility identifiers.

Orange Book vs. Drugs@FDA vs. SPL

• Orange Book: patent protection, exclusivity, NDA assignment, dosage form granularity.
• Drugs@FDA: approval and labeling documents.
• SPL: structured product data that most directly identifies the manufacturer and packer facility names tied to the marketed product.

QINLOCK dosage form exposure relevant to suppliers

QINLOCK is marketed as 50 mg tablets (ripretinib). Supplier obligations track to that dosage form and strength because tablet manufacturing and packaging steps are performed per strength and container configuration.

Which companies supply the ripretinib API used in QINLOCK?

Short answer: ripretinib API supply is sourced from GMP-registered API manufacturing sites disclosed via FDA SPL and establishment registrations tied to the QINLOCK NDA.

API supply chain structure

Typical ripretinib supply chain contains:

• API synthesis and crystallization steps at one or more GMP API sites
• API milling, blending, and testing (as needed) before release to tablet manufacturing
• Quality release testing transfer points between API supplier and tablet maker

How API supplier identification is confirmed

The most reliable public trace is:

• FDA SPL for the NDA product: identifies the listed manufacturer(s) for drug substance.
• FDA facility registration: confirms GMP registration and operational role for each establishment.

Who packages QINLOCK tablets (bottles and cartons) and provides labels?

Short answer: Packaging and labeling are performed by FDA-listed packer/labeler sites associated with the QINLOCK NDA, typically separate from tablet manufacturing sites.

Packaging supplier tasks

Packaging suppliers handle:

• Bottle/carton production and filling coordination
• Label application and printing verification
• Serialization or country-specific label variants where required
• Batch reconciliation and QA disposition prior to market release

Why packaging sites matter in supply disruptions

When there is a shortage, the bottleneck can shift from API production to:

• finished-goods packaging throughput
• label availability and serialization schedules
• QA disposition capacity at the packer site

What supply partners support QINLOCK in the US market?

Short answer: The US supply chain relies on FDA-registered manufacturing and packer sites tied to the NDA that supports US distribution, with Novartis maintaining NDA oversight for GMP release and quality.

Contract manufacturing model commonly used in oncology oral TKIs

For oncology oral drugs like QINLOCK, the supplier model often uses:

• one API supplier network feeding
• one or more tablet manufacturing sites
• one or more packaging/labeling sites

This structure reduces single-site risk but still concentrates compliance requirements to a finite set of registered establishments.

How strong is QINLOCK’s commercial supplier resilience if demand rises?

Short answer: Supplier resilience depends on the number of registered tablet manufacturing and packaging sites available under the NDA supply chain. Where the NDA supports multiple CMO sites, throughput and contingency planning improves.

What to check for resilience

Supply resilience can be inferred from:

• presence of multiple drug product manufacturing establishments
• presence of multiple packer/labeler establishments
• history of manufacturing site updates tied to CMC supplements

Do QINLOCK suppliers differ by tablet strength or container configuration?

Short answer: Yes, in practice. Even when the same facility manufactures multiple strengths, packaging configurations and labeling variants create different packer and labeler workflows.

What changes between configurations

• bottle count and NDC presentation
• label language and serialization
• distinct batch sizes and container fill processes

What generic or biosimilar supplier risks exist for QINLOCK supply?

Short answer: QINLOCK is a small-molecule oncology drug (not a biologic), so the supplier and market risk comes primarily from:

• generic entry affecting purchasing volume and
• potential changes in demand signals to the supplier base

How patent and exclusivity status impacts supplier incentives

If exclusivity or patent barriers delay generic supply, demand remains concentrated on the branded supply chain. Supplier capacity planning can therefore remain oriented to branded volumes until legal resolution changes market structure.

Key Takeaways

• QINLOCK supply is driven by a contracted GMP network: API manufacturers, tablet drug-product manufacturers, and packaging/labeler sites registered under the QINLOCK NDA.
• The most defensible supplier list is obtained by cross-referencing FDA SPL manufacturing/packing information tied to the NDA with FDA establishment registration.
• Packaging suppliers can be the bottleneck during shortages due to label and container configuration requirements even when tablet manufacturing capacity exists.

FAQs

Which FDA database provides the most direct supplier names for QINLOCK?

The SPL (Structured Product Labeling) manufacturing and packaging records tied to the QINLOCK NDA provide the most direct facility-level supplier identifiers.

Can QINLOCK tablets be manufactured by more than one contract manufacturer?

Yes. Many oral oncology drugs use multiple registered manufacturing establishments under the same NDA to support supply continuity.

Are QINLOCK packaging and labeling roles always at the same site as tablet manufacturing?

No. Packaging and labeling are frequently performed at separate FDA-listed packer/labeler sites from tablet manufacturing.

How do I confirm whether an API site supplies ripretinib to QINLOCK?

Confirm via FDA NDA-linked SPL drug-substance manufacturing listings and cross-check with FDA establishment registration for that ripretinib API role.

What happens to supplier availability if FDA approves a CMC supplement adding a new manufacturing site?

The NDA-linked manufacturing network expands, improving throughput and reducing dependency on any single establishment, subject to validated tech transfer and QA release readiness.

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: QINLOCK (ripretinib). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. (n.d.). Structured Product Labeling (SPL) data for QINLOCK (ripretinib). FDA. https://dailymed.nlm.nih.gov/
3. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (QINLOCK). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm