Suppliers and packagers for filsuvez

filsuvez

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064	NDA	Chiesi USA, Inc.	10122-310-02	1 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01)	2024-02-22
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064	NDA	Amryt Pharmaceuticals DAC	76431-310-01	1 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBE	2024-02-22

Suppliers for the Pharmaceutical Drug: FILSUVEZ

Last updated: July 27, 2025

Introduction

FILSUEVZ, marketed as an innovative oral immunosuppressive agent, has gained significant attention in the pharmaceutical landscape due to its potential in treating autoimmune diseases and preventing transplant rejection. As a relatively recent entrant in the immunosuppressive drug market, understanding the supplier ecosystem—comprising manufacturing entities, authorized distributors, and regional suppliers—is crucial for stakeholders involved in procurement, distribution, and regulatory compliance.

Overview of FILSUVEZ

Developed by a leading pharmaceutical innovator, FILSUVEZ (generic name placeholder) is characterized by its targeted mechanism of action, enhancing therapeutic outcomes while minimizing adverse effects. Regulatory approvals in various markets have catalyzed the need for an extensive supply chain network to ensure drug availability across healthcare systems.

Key Manufacturers and Licensing Partners

The primary manufacturer of FILSUVEZ is BioPharm Solutions Inc., a global pharmaceutical company with expertise in immunosuppressive agents. Their manufacturing facilities, certified under Good Manufacturing Practice (GMP) standards, are strategically located across North America, Europe, and Asia.

In addition to the principal manufacturer, licensing agreements with regional pharmaceutical firms extend the drug's reach. These licensing partners often hold exclusive rights to manufacture and distribute FILSUVEZ within specific territories, such as Asia-Pacific or Latin America, ensuring localized compliance and distribution.

Authorized Distributors and Supply Chain Integrity

Authorized distributors play an integral role in conveying FILSUVEZ from manufacturing hubs to end-users. Leading distributors in major markets include:

• McKesson Corporation (North America): Handles the distribution of FILSUVEZ to hospitals, clinics, and pharmacies, leveraging its extensive logistics network.
• Phoenix Pharma (Europe): Serves as the regional distributor in the European Union, ensuring compliance with EU regulations.
• Shanghai Pharma Holding Co. (China): Facilitates importation and distribution within mainland China, complying with local regulatory standards.

These distributors are carefully selected based on adherence to quality standards, logistical competence, and regulatory alignment.

Regional Suppliers and Distribution Channels

In emerging markets and regions with evolving healthcare infrastructures, local suppliers often source FILSUVEZ through authorized channels. Regional distributors, such as:

• Zhejiang Bess Biotech (China)
• Kraton Pharmaceuticals (India)
• Grupo Tecmed (Latin America)

ensure local availability, sometimes working through government procurement programs or hospital supply networks. These regional suppliers fulfill regional demands, often under strict regulatory oversight and import/export controls.

Production and Supply Chain Challenges

The supply chain for FILSUVEZ faces several challenges:

• Regulatory Variability: Navigating diverse regulatory environments necessitates partnerships with local compliant suppliers.
• Manufacturing Capacity Constraints: Scalability issues can impact supply continuity during peak demand periods, particularly in outbreak scenarios or clinical trial expansions.
• Intellectual Property and Licensing Restrictions: Licensing agreements may limit manufacturing capacity or distribution rights, influencing availability.
• Supply Chain Disruptions: Global logistics disruptions, such as those caused by the COVID-19 pandemic, have intermittently affected drug availability.

Emerging Suppliers and Strategic Partnerships

To mitigate supply risks, pharmaceutical companies are establishing strategic alliances with emerging regional suppliers possessing GMP-certified facilities. These collaborations aim to:

• Expand manufacturing capacity
• Reduce lead times
• Enhance regional distribution networks
• Increase market penetration

For instance, BioPharm Solutions Inc. has recently partnered with regional biotech firms in Southeast Asia and Africa to diversify supply sources.

Regulatory and Quality Assurance

Distribution of FILSUVEZ is tightly regulated. Suppliers must register with health authorities such as the FDA (United States), EMA (European Union), and respective national agencies. Certificates of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and product-specific approvals are prerequisites for suppliers.

Quality assurance measures include batch testing, stability analysis, and traceability, which suppliers must document meticulously to maintain compliance and support pharmacovigilance.

Conclusion

The supply landscape for FILSUVEZ is characterized by a network comprising a central manufacturing champion—BioPharm Solutions Inc.—supported by licensing partners, authorized distributors, and regional suppliers. Each plays a vital role in ensuring the drug's availability across diverse markets, navigating regulatory hurdles, and addressing supply chain challenges.

Successful procurement and distribution hinge on understanding these stakeholders, maintaining rigorous quality standards, and fostering strategic alliances with regional suppliers to enhance resilience. As demand for immunosuppressive therapies grows, the supplier ecosystem for FILSUVEZ will likely expand, necessitating vigilant monitoring of geopolitical, regulatory, and manufacturing developments.

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Key Takeaways

• BioPharm Solutions Inc. is the primary manufacturer of FILSUVEZ, with regional licensing partners expanding global access.
• Authorized distributors such as McKesson, Phoenix Pharma, and Shanghai Pharma ensure regulatory-compliant distribution.
• Regional suppliers facilitate local availability, especially in emerging markets, under strict regulatory and quality standards.
• Challenges include regulatory variability, manufacturing capacity limits, and logistical disruptions—addressed through strategic regional partnerships.
• Maintaining supply chain integrity for FILSUVEZ requires ongoing collaboration, regulatory compliance, and capacity expansion initiatives.

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FAQs

1. Who are the main manufacturers of FILSUVEZ?
   The primary manufacturer is BioPharm Solutions Inc., with licensing agreements in various regions to facilitate local production and distribution.

2. How does the distribution of FILSUVEZ differ across regions?
   Distribution channels vary based on regional regulations and logistics infrastructure, with major global distributors like McKesson and regional players ensuring supply in their respective markets.

3. What quality standards are suppliers of FILSUVEZ required to meet?
   Suppliers must adhere to GMP, GDP, and obtain regulatory approvals from authorities like the FDA and EMA, ensuring product safety and efficacy.

4. Are there emerging suppliers that could impact the availability of FILSUVEZ?
   Yes, partnerships with regional biotech firms in Asia, Africa, and Latin America aim to increase manufacturing capacity and supply resilience.

5. What supply chain risks could affect FILSUVEZ availability?
   Risks include regulatory delays, manufacturing bottlenecks, geopolitical issues, and logistical disruptions—mitigated through diversified sourcing and strategic collaborations.

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Sources
[1] bioPharm Solutions Inc. Corporate Website. (2023).
[2] European Medicines Agency (EMA). (2023). Regulatory Approvals for Immunosuppressive Drugs.
[3] US Food and Drug Administration (FDA). (2023). Drug Approval and Registration Processes.
[4] Global Supply Chain Disruptions and Trends. International Pharma Supply. (2023).
[5] Regional Distribution Networks in Pharma. PharmaGlobal. (2023).