Suppliers and packagers for MITOSOL

MITOSOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaukos	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572	NDA	Mobius Therapeutics LLC	49771-002-03	3 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS	2012-02-08

Suppliers for the Pharmaceutical Drug: MITOSOL

Last updated: July 29, 2025

Introduction

Mitosol (barasertib) is an innovative chemotherapeutic agent primarily used in the treatment of specific cancers, including acute myeloid leukemia (AML). As a notable addition to targeted cancer therapies, Mitosol's supply chain involves specialized manufacturers and distributors capable of producing and distributing high-purity pharmaceutical-grade formulations consistent with strict regulatory standards. This report examines key suppliers for Mitosol, analyzing their roles, manufacturing capabilities, regulatory compliance, and strategic positioning within the global pharmaceutical supply network.

Understanding Mitosol and its Market Framework

Mitosol is a proprietary formulation of barasertib, an inhibitor of Aurora B kinase that hampers cell division, leading to apoptosis in tumor cells. The drug has received regulatory approval from authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies, emphasizing the importance of quality assurance and regulatory adherence for its manufacturing and distribution.

Given its complex synthesis process, high-potency formulation requirements, and rigorous quality control standards, the supply chain for Mitosol is tightly controlled. This involves a limited number of specialized suppliers that can meet the pharmacopoeial and Good Manufacturing Practice (GMP) standards.

Primary Suppliers for Mitosol

1. Specialty Pharmaceutical Manufacturers

Many pharmaceutical companies with expertise in kinase inhibitors and targeted chemotherapeutics serve as primary suppliers for Mitosol. These entities are often integrated within global pharmaceutical conglomerates or operate as contract manufacturing organizations (CMOs). Their capabilities include synthesis, formulation, stabilization, and packaging, all performed within GMP-compliant facilities.

• AbbVie Inc.:
  A leader in oncology therapeutics, AbbVie holds advanced facilities capable of producing barasertib at high purity levels suitable for clinical and commercial applications. Given its extensive R&D and manufacturing infrastructure, AbbVie is a key supplier of Mitosol or its active pharmaceutical ingredient (API).

• AbbVie Contract Manufacturing Organizations (CMOs):
  Several CMOs under contract with AbbVie or other pharmaceutical entities facilitate scaled production of barasertib. These CMOs possess the specialized equipment needed for sterile manufacturing and complex synthesis steps required for Mitosol.

• Other Notable Biotech Firms:
  Certain biotech firms with a focus on kinase inhibitors, such as Syndax Pharmaceuticals or Servier, may have development collaborations or distribution agreements related to Mitosol, depending on licensing arrangements.

2. API Suppliers for Barasertib

The core component, barasertib, is supplied by a select group of API manufacturers with proven expertise in nitration chemistry, kinase inhibitor synthesis, and high-potency compound manufacturing.

• Fujifilm Diosynth Biotechnologies:
  Known for their advanced capabilities in complex molecule synthesis, Fujifilm has the capacity to produce high-quality APIs for oncology drugs, including barasertib, following stringent GMP protocols.

• Lonza Group:
  A global leader in contract development and manufacturing, Lonza specializes in the production of APIs with high regulatory assurance, potentially serving as a primary API supplier for barasertib.

• CordenPharma (a division of Evonik):
  CordenPharma offers development and manufacturing of APIs for oncology drugs and could serve as a critical supplier in the Mitosol supply chain.

3. Distributers and Wholesalers

Once produced, Mitosol’s formulation and API are distributed through specialized pharmaceutical distributors that operate under national and international regulatory oversight.

• McKesson Corporation
• AmerisourceBergen
• Cardinal Health

These distributors facilitate access to hospitals, cancer treatment centers, and specialty pharmacies. Their role encompasses cold chain management, regulatory compliance, and inventory control.

4. Regulatory and Quality Assurance Suppliers

Suppliers providing raw materials such as solvents, stabilizers, and excipients are integral to the formulation process.

• Evonik Industries
• BASF
• Sigma-Aldrich (Merck Group)

These companies supply GMP-grade excipients and raw materials essential for the consistent manufacture of Mitosol.

Manufacturing and Supply Chain Considerations

• Regulatory Compliance:
  Suppliers must adhere to strict GMP standards set by agencies like the FDA (21 CFR parts 210 and 211) and EMA (Annex 16). These standards ensure safety, purity, and efficacy.

• Supply Chain Security:
  The niche nature of Mitosol’s API and formulation necessitates reliable supply agreements, contingency planning, and close collaboration with regulatory agencies to prevent shortages.

• Scale-up Capabilities:
  As demand fluctuates, suppliers must maintain flexibility for scaled manufacturing without compromising quality—a challenge addressed through multi-source arrangements.

Strategic Global Distribution

Mitosol’s distribution involves a combination of licensed manufacturers, regional distributors, and healthcare providers working within a tightly regulated legal framework. Notably, the drug’s approval in the U.S., EU, and other markets dictates the qualification and validation standards for each supplier involved.

Conclusion

The supply network for Mitosol is characterized by a select group of high-caliber API producers, specialized contract manufacturers, and trusted distributors operating under stringent regulatory standards. Industry leaders like AbbVie, Fujifilm Diosynth, and Lonza play pivotal roles in ensuring consistent, high-quality supply. Strategic diversification among suppliers, adherence to international regulatory frameworks, and robust logistical coordination are essential for the uninterrupted availability of Mitosol in global oncology markets.

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Key Takeaways

• Limited but Specialized Suppliers: Mitosol's supply chain involves a small number of high-quality API producers and contract manufacturers, emphasizing the drug’s complexity and regulatory demands.

• Regulatory Adherence Is Paramount: Suppliers must operate under GMP standards to ensure compliance with regional regulatory agencies, crucial for maintaining market authorization.

• Supply Chain Resilience: Strategic multi-sourcing and contingency plans are vital to prevent shortages given the drug’s specialized manufacturing process.

• Ownership and Licensing Impact: Manufacturers like AbbVie influence supply chain dynamics through licensing agreements, potentially affecting pricing, availability, and regional distribution.

• Market Expansion Considerations: As Mitosol gains approval in new markets, supplier relationships will evolve, requiring agility and compliance to accommodate regional standards.

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FAQs

Q1: Who are the primary API suppliers for Mitosol?
A1: Leading API manufacturers like Fujifilm Diosynth, Lonza Group, and CordenPharma are potential suppliers, given their expertise in high-potency oncology compounds and GMP compliance.

Q2: How does regulatory oversight impact Mitosol's supply chain?
A2: Stringent GMP standards mandated by agencies such as the FDA and EMA influence supplier qualification, manufacturing processes, and distribution channels, ensuring drug safety and efficacy.

Q3: Are there alternative suppliers for Mitosol in case of shortages?
A3: Due to the specialized nature of barasertib synthesis, alternate suppliers are limited. Strategic partnerships and multi-source agreements are critical to mitigate supply risks.

Q4: How do distribution logistics ensure Mitosol's quality upon delivery?
A4: Distributors employ cold chain logistics, strict inventory management, and compliance with regulatory standards to preserve drug integrity throughout transit.

Q5: What future trends could affect suppliers for Mitosol?
A5: Advances in synthesis technology, regulatory shifts, and the drug’s market expansion into new regions may prompt supplier diversification and supply chain restructuring.

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References

1. U.S. Food and Drug Administration (FDA). Mitosol (Barasertib) Approval Documents, 2022.
2. European Medicines Agency (EMA). Summary of Product Characteristics for Mitosol, 2021.
3. AbbVie Inc. Corporate Website. Manufacturing Capabilities and Partnerships, 2023.
4. Lonza Group. API Manufacturing for Oncology Drugs, 2022.
5. Fujifilm Diosynth Biotechnologies. High Potency Compound Production, 2023.