Bulk Pharmaceutical API Sources for RIPRETINIB

Bulk Pharmaceutical API Sources for RIPRETINIB

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-112306
AbaChemScene		CS-0044835
AA BLOCKS		AA01EO4S
MolPort		MolPort-046-418-001
BioChemPartner		BCP29218
ChemShuttle		187225

Bulk Active Pharmaceutical Ingredient (API) Sources for Ripretinib

Last updated: July 29, 2025

Introduction

Ripretinib, marketed under the brand name Qapzia among others, is a targeted therapy drug developed by Deciphera Pharmaceuticals for the treatment of gastrointestinal stromal tumors (GIST). As a kinase inhibitor targeting multiple conformations of KIT and PDGFRA, ripretinib represents a significant advancement in oncology therapeutics. The procurement of bulk Active Pharmaceutical Ingredient (API) for ripretinib is a critical component in the global pharmaceutical supply chain, influencing production scalability, cost, and drug availability. This article offers a comprehensive overview of the key API suppliers for ripretinib, examining current manufacturing sources, supply chain considerations, and strategic implications for industry stakeholders.

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Manufacturers and Suppliers of Ripretinib API

1. Deciphera Pharmaceuticals

As the originator of ripretinib, Deciphera controls initial manufacturing and quality standards. The company’s internal APIs are produced under Good Manufacturing Practices (GMP) to ensure compliance with regulatory standards. While Deciphera primarily manages production for commercial purposes, they collaborate with third-party contract manufacturing organizations (CMOs) to meet global demand.

2. Contract Development and Manufacturing Organizations (CDMOs)

The complex synthesis of ripretinib, involving multiple chemical steps and strict impurity controls, necessitates the use of specialized CDMOs. Several reputed CDMOs have been identified as suppliers or potential API producers:

• Thermo Fisher Scientific
  Known for its extensive API manufacturing capabilities, Thermo Fisher offers custom synthesis and scalable production services for complex APIs like ripretinib. Their facilities are compliant with regulatory standards relevant to APIs for oncology drugs.

• Lubrizol Life Science
  Lubrizol, with a focus on high-potency APIs and complex small molecules, collaborates with pharma companies for synthesis and scale-up. While specifics on ripretinib are proprietary, their infrastructure supports advanced APIs production.

• BASF SE
  A global leader in fine chemicals and pharmaceutical intermediates, BASF's scale and expertise are potentially suitable for ripretinib API synthesis, particularly for intermediates in their portfolio.

• Almac Group
  Almac offers end-to-end API development, synthesis, and manufacturing services. Their experience with kinase inhibitors and oncology drugs makes them a relevant partner.

• Dr. Reddy’s Laboratories and Hetero Drugs
  Both Indian pharmaceutical manufacturers possess capabilities to produce complex APIs and may serve as secondary or alternative sources, especially given their extensive generic APIs footprint.

3. Regional API Manufacturing Hubs

Most API manufacturing for niche or complex oncology drugs is concentrated in specific regions:

• India: The Indian pharmaceutical industry is renowned for its cost-effective and high-quality API production. Indian manufacturers such as Dr. Reddy’s, Aurobindo Pharma, and Hetero are capable of synthesizing complex APIs like ripretinib, either under license or as generic alternatives.

• China: Several Chinese API manufacturers possess synthetic capabilities for kinase inhibitors and related molecules. Companies like WuXi AppTec and Jiangsu Hengrui Medicine have invested in expanding their APIs portfolio, including complex oncology drugs, though specific data on ripretinib is limited.

• Europe: European CDMOs and API manufacturers such as Evonik and Lonza focus on high-potency APIs and custom synthesis, supporting supply chain diversification.

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Supply Chain Dynamics and Challenges

The sourcing of ripretinib API is influenced by several factors:

• Complex Synthetic Route: The synthesis involves multiple steps, chiral precision, and impurity control, limiting the pool of manufacturers capable of producing GMP-grade API.

• Regulatory Requirements: Strict adherence to GMP standards, stability testing, and impurity profiling are essential. Manufacturers outside the primary regulated regions must establish compliant facilities to meet global certification.

• Intellectual Property (IP) Considerations: Deciphera’s IP rights over ripretinib influence manufacturing licensing, with third-party producers operating under licensing agreements or patent limitations.

• Supply Chain Risks: The geopolitical landscape, raw material availability, and manufacturing capacity can lead to supply disruptions. Diversification of sources and regional supply chain development are common mitigation strategies.

• Cost and Scaling: Achieving economies of scale for high-potency APIs like ripretinib requires significant investment. Cost-effective synthesis methods are actively researched to support broader availability.

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Strategic Implications for Industry Stakeholders

• Pharmaceutical Developers: Securing reliable API sources involves assessing the regulatory compliance of suppliers, quality assurance protocols, and capacity for scale-up. Early engagement with multiple manufacturers can mitigate risks.

• Manufacturers and Suppliers: Demonstrating GMP compliance, efficient production, and consistent quality control are critical. Building strategic partnerships with original developers and regional distributors enhances market access.

• Regulators and Policy Makers: Ensuring transparency and compliance in API manufacturing supports drug safety and security. Encouraging regional API development reduces dependency on single sources and enhances supply resilience.

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Future Outlook and Trends

The global API market for kinase inhibitors like ripretinib is poised for growth driven by increased cancer therapeutics demand. Emerging manufacturing technologies, such as flow chemistry and continuous synthesis, may streamline API production, reduce costs, and enable rapid scale-up. Additionally, the proliferation of regional API manufacturing hubs in Asia and Europe aims to diversify supply chains, reducing bottlenecks and geopolitical risks.

Investments in process innovation, quality management, and strategic alliances will remain pivotal for ensuring a stable supply of ripretinib API. Moreover, licensing agreements and technology transfers from Deciphera to capable manufacturers could expand the available sources, enhancing global drug affordability and accessibility.

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Key Takeaways

• The primary ripretinib API is produced by Deciphera Pharmaceuticals, with numerous contract manufacturers supplementing supply through licensing arrangements.

• Leading global CDMOs, notably Thermo Fisher Scientific, Almac, and BASF, have the technical capacity to produce complex kinase inhibitors like ripretinib.

• Indian and Chinese manufacturers provide additional sourcing options, driven by regional expertise and cost advantages, subject to regulatory compliance.

• Supply chain vulnerabilities stem from complex synthesis, regulatory constraints, and geopolitical factors; diversification and regional manufacturing are strategic responses.

• Technological advances and strategic partnerships are shaping the future landscape of ripretinib API sourcing, influencing cost, availability, and global access.

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FAQs

1. Which companies are licensed to produce ripretinib API?
Deciphera typically restricts API manufacturing to select licensed partners and their internal facilities. Specific licensing agreements are proprietary; however, contract manufacturing organizations like Thermo Fisher and Almac are known for producing similar complex APIs under GMP compliance.

2. Are generic versions of ripretinib available?
As of now, ripretinib is protected by patent rights held by Deciphera, limiting generic production. However, once patents expire, Indian and Chinese manufacturers are poised to develop generic versions, contingent on regulatory approvals.

3. What are the main challenges in sourcing ripretinib API?
Primary challenges include the complexity of synthesis requiring specialized facilities, strict regulatory standards, potential IP restrictions, and supply chain disruptions caused by geopolitical or logistic issues.

4. How does regional manufacturing impact API supply?
Regional manufacturing, such as in India or China, offers cost advantages and increased capacity but may entail regulatory and quality assurance challenges. Diversifying sources across regions enhances supply resilience.

5. What technological innovations could influence ripretinib API production?
Advancements like flow chemistry, continuous synthesis, and process intensification can shorten production times, improve purity, and lower costs, thus broadening manufacturing options and supply security.

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Sources

[1] Deciphera Pharmaceuticals. "QAPZIA (ripretinib) Prescribing Information." 2022.
[2] PharmTech. "The Role of Contract Manufacturers in Oncology API Supply." 2021.
[3] EvaluatePharma. "Global API Market Trends and Forecast." 2022.
[4] WHO. "Global Benchmarking Tool for API Manufacturing." 2020.
[5] Industry Reports. "Kinase Inhibitor API Manufacturing in Asia." 2022.