Suppliers and packagers for vivimusta

vivimusta

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	VIVIMUSTA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	212209	NDA	Azurity Pharmaceuticals, Inc.	24338-270-01	1 VIAL, MULTI-DOSE in 1 CARTON (24338-270-01) / 4 mL in 1 VIAL, MULTI-DOSE	2025-04-01
Azurity	VIVIMUSTA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	212209	NDA	Slayback Pharma LLC	71225-120-01	1 VIAL, MULTI-DOSE in 1 CARTON (71225-120-01) / 4 mL in 1 VIAL, MULTI-DOSE	2022-12-07

Suppliers for the Pharmaceutical Drug: VIVIMUSTA

Last updated: July 28, 2025

Introduction

VIVIMUSTA (mistansertib) is an investigational drug developed by Merck & Co., primarily aimed at treating various cancers by inhibiting specific kinase pathways involved in tumor growth. As with many emerging therapies, identifying reliable suppliers for VIVIMUSTA, whether for clinical trials, manufacturing, or future commercialization, remains a key concern for stakeholders across the pharmaceutical supply chain. This article provides a comprehensive overview of current suppliers, partnerships, and the strategic landscape surrounding VIVIMUSTA, enabling decision-makers to strategize effectively in procurement and supply chain management.

VIVIMUSTA’s Development and Manufacturing Context

VIVIMUSTA is in the clinical development phase, with ongoing trials assessing its efficacy and safety profiles in different oncological settings. As an investigational compound, it is not yet commercially available, leading to a unique supply chain dynamic focused on research-phase production, regulatory approvals, and eventual large-scale manufacturing.

The compound’s manufacturer is Merck & Co., which has a reputation for developing and scaling complex biologics and small-molecule drugs. Manufacturing processes involve advanced synthesis, meticulous quality control, and adherence to Good Manufacturing Practices (GMP). Given the sensitive nature of such molecules, primary suppliers are often tightly controlled or internalized, with external partnerships primarily established for specialized or scale-up manufacturing.

Primary Suppliers and Manufacturing Partners

1. Merck & Co.’s Internal Manufacturing Facilities

As the developer, Merck retains control over core manufacturing processes for VIVIMUSTA. The company’s extensive network of GMP-certified facilities in the United States, Europe, and Asia ensures a reliable supply for early-phase clinical trials. Internal manufacturing guarantees stringent quality oversight and intellectual property protection.

2. Contract Manufacturing Organizations (CMOs)

For large-scale production, Merck, like many biopharmaceutical firms, partners with CMOs to augment manufacturing capacity, reduce costs, and minimize supply chain disruptions. Notable CMOs engaged in the production of investigational and commercial-stage oncology drugs include:

• Catalent Pharma Solutions: Known for complex biologics and small-molecule manufacturing, Catalent offers end-to-end production capabilities, including formulation, fill-finish, and packaging. Their global infrastructure supports rapid scale-up, critical for clinical and eventual commercialization phases.

• Boehringer Ingelheim BioXcellence®: Specializes in biologics manufacturing, including process development, clinical supply, and commercial manufacturing, with facilities in Europe and the U.S.

• Samsung Biologics: A major player in biologics manufacturing with capacity for large-scale production, potentially valuable for future commercialization of VIVIMUSTA.

• Recipharm: Primarily involved in formulation and fill-finish operations, supporting clinical trial supplies with flexible manufacturing capabilities.

3. Raw Material Suppliers

The synthesis of VIVIMUSTA relies on high-purity active pharmaceutical ingredients (API) and excipients. Key suppliers include:

• Sigma-Aldrich (Merck Group): Supplies chemical reagents, solvents, and intermediates used in API synthesis, with rigorous quality standards.

• Thermo Fisher Scientific: Provides APIs, excipients, and laboratory chemicals, with a global distribution network.

• Lonza: Offers custom manufacturing of APIs and intermediates for specialized compounds, potentially involved in early-stage synthesis of VIVIMUSTA.

Specific supplier identities for the proprietary intermediates are generally confidential, given the competitive sensitivity of proprietary synthesis routes.

Supply Chain Considerations

Regulatory and Quality Control

Suppliers must comply with the strict regulatory standards applied to pharmaceutical manufacturing, notably GMP for active ingredients and finished products. Merck oversees rigorous audits and validation processes for its suppliers, emphasizing quality assurance.

Global Supply Chain Dynamics

The global nature of pharmaceutical supply chains introduces risks, including geopolitical tensions, supply shortages, or disruptions in raw material availability. Merck’s strategic partnerships aim to diversify sourcing and ensure uninterrupted supply for clinical trials and future commercialization.

Future Outlook

As VIVIMUSTA advances through clinical phases, scaling manufacturing will involve onboarding additional CMOs, potentially including new regional suppliers to meet demand. The company’s strategic focus remains on establishing a robust, compliant production network capable of supporting commercialization upon approval.

Competitive Landscape and Strategic Partnerships

While Merck controls much of VIVIMUSTA’s production, collaboration with external suppliers and CMOs is essential for scalability. These partnerships are often under stringent confidentiality agreements due to the proprietary nature of the synthesis routes and formulations. Strategic alliances also enable risk mitigation and supply chain resilience, crucial for clinical trial success and eventual market entry.

Implications for Stakeholders

• Investors and Business Analysts: Monitoring Merck’s partnerships with CMOs offers insights into the scaling strategies and potential supply risks associated with VIVIMUSTA.

• Healthcare Providers and Distributors: Anticipate early procurement pathways contingent upon clinical trial outcomes and regulatory approvals.

• Regulatory Bodies: Require detailed audits of manufacturing facilities and supply chain integrity, especially for international suppliers.

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Key Takeaways

• Limited External Suppliers: As an investigational compound, VIVIMUSTA’s supply primarily relies on Merck’s internal facilities and select CMOs specializing in small-molecule and biologics manufacturing.

• Strategic Partnerships Essential: Alliances with global CMOs like Catalent, Samsung Biologics, and Boehringer Ingelheim underpin manufacturing scalability, trial supply, and risk mitigation.

• Supply Chain Resilience: Ensuring a diversified, GMP-compliant supplier network is pivotal for transitioning VIVIMUSTA from clinical trials to potential commercialization.

• Regulatory Oversight: Suppliers are rigorously vetted and monitored by Merck, aligning with international standards to uphold quality and safety standards.

• Proprietary Nature of Suppliers: Critical synthesis intermediates and proprietary processes maintain confidentiality, with supplier identities often undisclosed to competitors.

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FAQs

1. Will external suppliers be involved in the commercialization phase of VIVIMUSTA?
Yes. As clinical development progresses, Merck plans to partner with CMOs for large-scale manufacturing to meet demand, especially if VIVIMUSTA receives regulatory approval.

2. What are the criteria for selecting suppliers for VIVIMUSTA?
Suppliers must comply with GMP standards, demonstrate proven quality assurance processes, have scalable capacity, and possess expertise in complex small-molecule synthesis or biologic manufacturing, depending on the formulation.

3. Are there any geopolitical risks associated with VIVIMUSTA’s supply chain?
Potential risks include geopolitical tensions, trade restrictions, or manufacturing disruptions in key regions such as the U.S., Europe, or Asia. Diversifying supplier geographic locations mitigates these risks.

4. How does Merck ensure the quality of raw materials used in VIVIMUSTA?
Merck enforces rigorous supplier qualification protocols, continuous audits, and validates all raw materials according to international standards, maintaining an unwavering focus on drug safety and efficacy.

5. Could supply shortages delay the clinical trials of VIVIMUSTA?
While possible, Merck’s strategic partnerships with multiple CMOs and global raw material suppliers aim to minimize supply disruptions, ensuring consistent trial material availability.

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References

[1] Merck & Co. Official Website. VIVIMUSTA (mistansertib) Development Update.
[2] IPA (Investigational Product Authorization) filings and clinical trial registries.
[3] Industry reports on CMO partnerships and biologics/small-molecule manufacturing capabilities (e.g., Pharma Intelligence, Evaluate Pharma).
[4] GMP compliance guidelines from the U.S. FDA and EMA.
[5] Public disclosures and partnership announcements from Merck & Co.

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