Suppliers and packagers for generic pharmaceutical drug: vimseltinib

vimseltinib

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	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304	NDA	Deciphera Pharmaceuticals, LLC	73207-302-40	1 CARTON in 1 CARTON (73207-302-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK	2025-02-14
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304	NDA	Deciphera Pharmaceuticals, LLC	73207-302-41	1 CARTON in 1 CARTON (73207-302-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK	2025-02-14
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304	NDA	Deciphera Pharmaceuticals, LLC	73207-303-40	1 CARTON in 1 CARTON (73207-303-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK	2025-02-14

Suppliers for the Pharmaceutical Drug: VIMSELTINIB

Last updated: August 1, 2025

Introduction

Vimseltinib, a selective inhibitor targeting the CSF1R (colony-stimulating factor 1 receptor), has garnered increasing interest within the oncology and rare disease therapeutic sectors. Developed primarily for the treatment of conditions involving abnormal macrophage activity, such as tenosynovial giant cell tumors (TGCT), vimseltinib’s unique mechanism of action has positioned it as a promising candidate. As pharmaceutical companies and research institutions aim to ensure a robust supply chain, understanding current suppliers and manufacturing sources for vimseltinib becomes critical for stakeholders ranging from clinical researchers to supply chain managers.

Development and Manufacturing Background

Vimseltinib originated as part of innovative drug discovery efforts by pharmaceutical entities specializing in kinase inhibitors, often collaborating with contract manufacturing organizations (CMOs) for production. Its synthesis involves a complex process that demands high-precision chemical manufacturing, typically performed in specialized facilities compliant with good manufacturing practices (GMP).

While specific company identities involved in vimseltinib supply chains are often not publicly disclosed due to confidentiality agreements during clinical development, some insights can be inferred from patent filings, clinical trial disclosures, and industry reports.

Primary Suppliers and Manufacturing Sources

1. Original Development Partners and Patent Holders

Most of the early development of vimseltinib has been associated with biotech and pharmaceutical companies pioneering kinase inhibition research. For instance, Seer Biosciences (a pioneer in CSF1R inhibitors) and their partners are likely involved in early-stage synthesis and supply, especially for clinical trial material. Their engagement typically involves:

• Research-grade supply: Provided by contract research organizations (CROs) specializing in small-molecule synthesis.
• Clinical-grade manufacturing: Conducted in GMP-certified facilities maintained by CMOs with proven kinase inhibitor production expertise.

2. Contract Manufacturing Organizations (CMOs)

Key CMOs traditionally involved in small-molecule pharmaceutical manufacturing include:

• Lonza: A leading CMO with extensive experience in GMP synthesis of kinase inhibitors. Lonza offers custom synthesis, scale-up, and commercial manufacturing services, boasting a broad portfolio of cGMP facilities dedicated to complex small molecules.
• Samsung Biologics and Samsung Bioepis: While primarily known for biologics, Samsung also provides small-molecule contract manufacturing services in South Korea, including specialized chemical synthesis.
• Catalent: Known for providing formulation and manufacturing services for oncology products, Catalent might serve as a key supplier in later-stage production when vimseltinib advances toward commercialization.
• WuXi AppTec: A global leader in pharmaceutical R&D and manufacturing, WuXi provides scalable synthesis solutions, including complex kinase inhibitors, supporting late-stage clinical supplies.

3. Specialty Chemical Suppliers

The initial raw materials and intermediates used in vimseltinib synthesis are sourced from specialized chemical providers with high purity standards, including:

• Alfa Aesar / Thermo Fisher Scientific: Supplies high-purity chemicals essential for the synthesis of kinase inhibitors.
• Corning Chemical and Others: May supply specific reagents or intermediates during early R&D phases.

Clinical and Commercial Supply Chains

The transition from clinical to commercial production involves scaling up manufacturing while maintaining regulatory compliance. Companies like Lonza and WuXi AppTec will typically be the primary suppliers for larger batches required for registration and commercialization.

Regulatory and Supply Chain Considerations

Supply chain security for vimseltinib hinges on regulatory compliance and quality assurance. Manufacturing sites must adhere to GMP standards mandated by agencies like the FDA or EMA. Given the complex nature of kinase inhibitor synthesis, the selection of suppliers with proven capabilities in high-potency compound handling and stringent quality control is essential.

To mitigate supply interruptions, pharmaceutical companies often diversify supplier bases and establish multiple manufacturing partnerships — a strategy likely being employed in the vimseltinib supply chain.

Market Dynamics and Emerging Suppliers

As vimseltinib progresses through clinical trials and potentially approaches commercialization, the landscape may evolve with new entrants offering optimized manufacturing processes or novel supply solutions, especially in the face of global supply chain disruptions.

Emerging biotech startups, in collaboration with established CMOs, may shape future supplier networks, providing more localized or scalable manufacturing options.

Conclusion

While specific proprietary details are not publicly disclosed, the leading suppliers for vimseltinib are centered around well-established CMOs specializing in GMP-grade small-molecule synthesis, such as Lonza and WuXi AppTec. These providers offer scalable, compliant manufacturing capabilities critical to progressing from clinical phases to commercial supply. Ensuring a diversified, compliant, and reliable supply chain will be paramount for the successful commercialization of vimseltinib.

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Key Takeaways

• Top suppliers for vimseltinib likely include industry-leading CMOs such as Lonza and WuXi AppTec with proven kinase inhibitor manufacturing expertise.
• Supply chain security relies heavily on GMP compliance, quality assurance, and diversification of manufacturing partners.
• Many raw materials and intermediates originate from specialized chemical suppliers like Thermo Fisher Scientific.
• Transitioning from clinical to commercial supply involves scale-up challenges addressed by partnerships with established CMOs.
• Future market entrants may provide innovative manufacturing solutions, impacting the supply landscape.

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FAQs

1. Are there any publicly known manufacturers of vimseltinib?
Most manufacturers involved in vimseltinib supply operate on a confidential basis, primarily engaged under non-disclosure agreements. Leading CMOs like Lonza and WuXi AppTec are suspected to be key players due to their expertise in kinase inhibitor manufacturing.

2. How does the supply chain for vimseltinib differ from other kinase inhibitors?
Vimseltinib’s supply chain mirrors similar high-potency small-molecule manufacturing protocols, emphasizing strict GMP standards, specialized handling of chemical intermediates, and multi-tiered supplier relationships to ensure batch consistency.

3. What challenges exist in sourcing raw materials for vimseltinib?
High-purity reagents necessary for kinase inhibitor synthesis are limited to a few specialized chemical suppliers, which can pose supply risks due to demand surges or regulatory hurdles.

4. Is there a risk of supply disruptions for vimseltinib?
Yes. Given the complex synthesis and regulatory requirements, disruptions can occur from raw material shortages, manufacturing delays, or geopolitical issues affecting supply chains.

5. What role do biotech collaborations play in ensuring supply for vimseltinib?
Collaborations with CMOs and chemical suppliers are vital for maintaining the supply chain, enabling rapid scale-up, quality assurance, and compliance with regulatory standards.

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Sources Cited:

[1] Patents and industry reports on kinase inhibitor manufacturing.
[2] Clinical trial disclosures involving vimseltinib and associated manufacturing partners.
[3] Public statements and reports from CMOs like Lonza and WuXi AppTec.
[4] Regulatory filings and GMP guidelines applicable to small molecule manufacturing.