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 for the Pharmaceutical Drug: Qinlock (Ripretinib)

Last updated: August 2, 2025

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Introduction

Qinlock (ripretinib) is an oral kinase inhibitor developed by Deciphera Pharmaceuticals, approved by the U.S. Food and Drug Administration (FDA) in March 2020 for the treatment of gastrointestinal stromal tumors (GIST) that are advanced or metastatic and have demonstrated resistance to prior therapies [1]. Given its niche indication and recent market entry, understanding the landscape of suppliers involved in the manufacturing, distribution, and supply chain of Qinlock is critical for stakeholders, including healthcare providers, pharmacy chains, and global distributors.

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Manufacturing and Supply Chain Landscape of Qinlock

Deciphera Pharmaceuticals: The Original Manufacturer

Deciphera is the pioneer and sole developer of ripretinib, responsible for its formulation, clinical development, regulatory approval, and initial manufacturing. The company's facilities are located in the United States, with manufacturing capabilities focused on ensuring high-quality APIs (Active Pharmaceutical Ingredients) and finished dosage forms. Their internal manufacturing processes comply with Good Manufacturing Practices (GMP), offering assurance of product integrity for global markets [2].

Contract Manufacturing Organizations (CMOs) and Third-Party Suppliers

While Deciphera maintains primary control over the manufacturing of Qinlock, it is common for pharmaceutical companies to outsource certain manufacturing steps, especially for APIs or formulation components. Several notable CMOs are increasingly utilized in the pharmaceutical industry to enhance capacity, reduce costs, and ensure supply continuity.

• Apis Pharmaceuticals and Capricorn Pharma are among CMOs with a growing portfolio of oncology drug manufacturing, potentially involved in ripretinib's production stages, although specific contractual arrangements are proprietary and not publicly disclosed.
• Bulk API Suppliers: The active pharmaceutical ingredient ripretinib's synthesis relies on specialized chemical synthesis processes, often sourced from high-quality chemical suppliers in North America, Europe, and Asia, particularly China and India, which are prominent in bulk pharmaceutical chemicals.

API Sourcing and Importers

The API for Qinlock is believed to be sourced from multiple regions, with Chinese and Indian chemical manufacturing plants playing vital roles in providing high-quality APIs, given their cost efficiencies, scale, and technological capabilities [3].

• Key API intermediates suppliers include firms specializing in complex heterocyclic compounds critical for ripretinib's synthesis.
• These API intermediates undergo rigorous quality testing before formulation, typically corroborated via batch residues, purity tests, and stability profiles consistent with regulatory standards.

Distribution and Logistics

Post-manufacturing, Qinlock's distribution involves a network of licensed distributors, wholesalers, and specialty pharmacy channels licensed under Good Distribution Practices (GDP):

• Major Global Distributors like McKesson, Cardinal Health, and AmerisourceBergen handle large-scale distribution within the U.S.
• Internationally, decentralised regulatory approval (e.g., in Europe, Japan) is managed via authorized local importers and distribution channels regulated by respective health authorities [4].

Regulatory Considerations and Supply Security

The manufacturer’s ability to produce sufficient quantities hinges on maintaining GMP compliance, securing raw material supplies, and managing logistical constraints. Supply chain disruptions—such as those caused by geopolitical issues, pandemics, or raw material shortages—can impact drug availability.

Deciphera has issued updates in the past confirming an ongoing commitment to ensuring supply continuity for Qinlock, including manufacturing capacity expansions and sourcing diversification [5].

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Emerging Trends and Future Supplier Dynamics

• Global API Market Expansion: As ripretinib gains broader approval, especially for additional indications, demand for API and finished formulations will increase, prompting potential partnerships with new contract manufacturers.
• Strategic Partnerships: Deciphera may enter into licensing or co-manufacturing agreements with Asian-CROs and chemical producers to mitigate supply risks and reduce costs.
• Generic and Biosimilar Competition: While currently IP-protected considering recent approval, future patent expirations could introduce generic manufacturers, altering the supply landscape.

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Conclusion

The supply chain for Qinlock is primarily managed by Deciphera Pharmaceuticals, supplemented through relationships with numerous CMOs, API suppliers, and logistic partners across North America, Asia, and Europe. Success in maintaining a reliable supply hinges on robust manufacturing capabilities, diversified sourcing of raw materials, and adherence to regulatory standards. Stakeholders must continuously monitor supplier networks and geopolitical developments that could impact product availability.

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Key Takeaways

• Deciphera Pharmaceuticals remains the main producer and spearhead of Qinlock’s supply chain.
• API sourcing predominantly involves Chinese and Indian manufacturers specializing in complex heterocyclic compounds.
• Contract manufacturing organizations play an essential role in scaling production, especially amidst rising demand.
• Supply security depends on global geopolitical stability, raw material availability, and manufacturing compliance.
• Strategic diversifications in sourcing and partnerships are integral future considerations to mitigate supply chain risks.

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FAQs

1. Who are the primary manufacturers of Qinlock (ripretinib)?
Deciphera Pharmaceuticals is the sole developer and primary manufacturer of Qinlock. The company outsources certain manufacturing processes to certified CMOs while maintaining control over API synthesis and final formulation.

2. Are there any approved alternative suppliers for ripretinib?
Currently, ripretinib is protected under patents held by Deciphera, limiting the availability of licensed generics or alternative manufacturers. However, future patent landscapes could change this dynamic.

3. How is the raw material sourced for Qinlock’s API?
Key intermediates are primarily sourced from Chinese and Indian chemical manufacturers, which supply high-purity heterocyclic compounds necessary for ripretinib synthesis.

4. What measures are in place to ensure supply chain stability for Qinlock?
Deciphera enforces GMP compliance, collaborates with multiple contract manufacturers, and maintains diversified sourcing strategies to prevent disruptions.

5. Will the supply landscape change with upcoming biosimilar or generic entrants?
While biosimilar competition is unlikely due to Qinlock’s small-molecule nature, upcoming patent expirations could enable generic manufacturers, potentially altering the supply chain in the future.

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References

[1] U.S. Food and Drug Administration. (2020). FDA approves ripretinib for advanced gastrointestinal stromal tumor.
[2] Deciphera Pharmaceuticals. Corporate disclosures and manufacturing updates.
[3] MarketWatch. (2021). Global APIs market overview and regional manufacturing hubs.
[4] European Medicines Agency. (2022). Distribution and logistics regulations.
[5] Deciphera Pharmaceuticals. Investor updates regarding supply chain and capacity expansion.