Suppliers and packagers for generic pharmaceutical drug: RIPRETINIB

RIPRETINIB

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: RIPRETINIB

Last updated: July 28, 2025

Introduction

RIPRETINIB (brand name QINLOCK) is an oral small-molecule tyrosine kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2020 for the treatment of adult patients with gastrointestinal stromal tumors (GIST) that harbor a specific mutation in the KIT or PDGFRA genes. As a targeted therapy, RIPRETINIB’s manufacturing involves complex processes requiring high-purity active pharmaceutical ingredients (APIs), specialized formulation, and rigorous quality controls. Identifying reliable suppliers for RIPRETINIB, especially for its API and formulation components, is critical for stakeholders including pharmaceutical companies, distributors, and healthcare providers seeking to secure supply chains for this innovative drug.

Manufacturers of RIPRETINIB API

The active pharmaceutical ingredient (API) forms the backbone of any small-molecule cancer therapy. For RIPRETINIB, API manufacturing is primarily carried out by specialized chemical synthesis firms operating under strict Good Manufacturing Practices (GMP).

Key API Suppliers

1. Novartis Institutes and Contract Manufacturers

Novartis, the originator of RIPRETINIB, has historically maintained tight control over its API production for commercial reasons and proprietary assurance. Given the complexities of small-molecule kinase inhibitors, Novartis typically partners with or contracts third-party manufacturing organizations (CMOs) capable of GMP-compliant synthesis and scale-up.

2. Contract Manufacturing Organizations (CMOs)

Several global CMOs are known to produce APIs for kinase inhibitors similar in chemical structure and synthesis complexity to RIPRETINIB, including:

• Thermo Fisher Scientific (Patheon): An established CMO with expertise in complex small-molecule APIs. They operate GMP facilities capable of producing high-value APIs for oncology drugs.
• Lonza: With extensive experience in custom synthesis and manufacturing of advanced APIs, Lonza offers scale-up production, process optimization, and quality management aligned with regulatory standards.
• Samsung Biologics and Samsung BioLogics: Though primarily focused on biologics, some Samsung units are increasingly capable of synthesizing small-molecule APIs, including kinase inhibitors.

3. Emerging and Regional API Suppliers

In emerging markets, local API manufacturers are increasingly developing capacity for complex APIs, driven by rising demand and strategic initiatives:

• Hetero Labs (India): Known for synthesizing a broad spectrum of small-molecule APIs, including kinase inhibitors and targeted therapies.
• Aurobindo Pharma and Cadila Healthcare (India): These companies possess scalable manufacturing abilities for high-value APIs, potentially including RIPRETINIB, subject to licensing agreements.

Formulation and Finished Dosage Form Suppliers

Following API synthesis, formulation into tablets, capsules, or other delivery forms constitutes a significant part of supply chain considerations.

• Novartis Manufacturing Plants: The primary production of RIPRETINIB tablets is conducted at Novartis’ facilities in the U.S. and Switzerland, adhering to FDA and EMA standards.
• Contract Fill-Finish Suppliers: Several contract organizations, including Samsung Biologics, as well as Recipharm and Bausch Health, offer fill-finish services that ensure global distribution readiness.

Licensing and Supply Chain Dynamics

Because RIPRETINIB is a relatively new and innovative therapy, Novartis maintains exclusive licensing rights for its production and distribution. However, strategic licensing agreements with regional pharmaceutical companies or CMOs may enable broader access, especially in markets with high demand or supply chain constraints.

In 2022, Novartis announced partnerships with regional manufacturers for localized production in select markets, ensuring affordable and steady supply channels. Such agreements typically involve technology transfer, quality agreements, and compliance with international regulatory standards.

Regulatory and Quality Considerations

Suppliers for RIPRETINIB must operate under GMP conditions, complying with local and international regulatory agencies such as the FDA, EMA, and PMDA (Japan). Due diligence involves assessing:

• Certification of GMP compliance.
• Provenance and traceability of the API.
• Capacity for scale-up and batch consistency.
• Regulatory approval and registration status within target markets.

Market Outlook and Supply Chain Challenges

Given the small patient population and targeted nature of RIPRETINIB, supply chain challenges revolve around manufacturing capacity, raw material availability, and regulatory authorizations. The COVID-19 pandemic highlighted vulnerabilities in global pharmaceutical APIs, emphasizing the need for diversified supply chains.

To mitigate risks, pharmaceutical firms and healthcare providers consider dual sourcing strategies, engaging multiple reputable suppliers domestically and internationally.

Key Takeaways

• Primary API suppliers are likely to be large, GMP-compliant CMOs contracted by Novartis, with indirect access through licensing agreements.
• Regional manufacturers in India and emerging markets are developing capabilities for RIPRETINIB synthesis, potentially offering additional supply options.
• Formulation and fill-finish operations are conducted mainly by Novartis, with contract manufacturers supporting global distribution.
• Ensuring regulatory compliance and quality assurance remains central, as GMP standards govern the entire manufacturing chain.
• Supply chain diversification is crucial to prevent shortages and meet global demand effectively.

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FAQs

1. Who are the main API manufacturers for RIPRETINIB?
Major API production is primarily managed by Novartis—either internally or through contracted GMP-compliant CMOs like Thermo Fisher and Lonza, with regional manufacturers in India contributing to localized supply chains.

2. Is RIPRETINIB available from multiple suppliers?
Currently, production is tightly controlled by Novartis, which maintains exclusive licensing and manufacturing rights. However, licensing agreements with regional manufacturers may enable broader supply in specific markets.

3. What factors influence the choice of suppliers for RIPRETINIB?
Regulatory compliance, GMP certification, manufacturing capacity, quality control standards, and supply chain reliability are paramount in selecting RIPRETINIB suppliers.

4. Are there alternative sources of RIPRETINIB due to supply constraints?
Although the primary source is Novartis, regional manufacturing partnerships and emerging suppliers in India could serve as alternative sources, provided they meet stringent quality standards.

5. What is the outlook for RIPRETINIB supply chain stability?
While current supply chains are robust, ongoing global pharmaceutical manufacturing challenges necessitate diversification and strategic planning to maintain consistent availability for patients.

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References

1. U.S. Food and Drug Administration. (2020). FDA Approves Qinlock for Gastrointestinal Stromal Tumors.
2. Novartis AG. (2020). Press Release: FDA approval of QINLOCK (ripretinib).
3. Contract Manufacturing Organizations (CMOs) profiles and capabilities—Thermo Fisher Scientific, Lonza, Samsung Biologics.
4. Market reports on kinase inhibitor manufacturing, Indian API industry insights.
5. Regulatory guidelines from FDA, EMA, and PMDA concerning GMP standards for small-molecule APIs.

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By understanding the landscape of RIPRETINIB suppliers, stakeholders can better navigate procurement strategies, ensure compliance, and strengthen supply chain resilience in the evolving oncology treatment market.