Suppliers and packagers for fyarro

fyarro

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312	NDA	Aadi Bioscience	80803-153-50	1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE	2021-12-06

Suppliers for the Pharmaceutical Drug: FYARRO

Last updated: July 27, 2025

Introduction

The pharmaceutical industry relies heavily on the global supply chain to ensure consistent availability, regulatory compliance, and quality standards of therapeutic agents. FYARRO (formally known as TIBSOVO) is an innovative oncology drug developed by Kibow Pharmaceuticals, primarily used for the treatment of specific advanced tumors. As a relatively recent entrant into the market, understanding its suppliers is vital for stakeholders concerned with manufacturing, procurement, and distribution strategies. This analysis provides a comprehensive overview of suppliers involved in the production of FYARRO, emphasizing raw material sourcing, manufacturing components, and distribution channels.

Overview of FYARRO

FYARRO (TIBSOVO) is an oral, selective inhibitor of the enzyme IDH1 (Isocitrate Dehydrogenase-1). It is designed to target mutated IDH1 enzymes prevalent in certain types of cancers, notably acute myeloid leukemia (AML). The drug's manufacturing process involves complex synthesis, requiring high-purity chemical intermediates, specialized excipients, and stringent quality control measures.

Key Components & Supply Chain for FYARRO

Active Pharmaceutical Ingredient (API) Supply

The core of FYARRO is its API, which precisely inhibits mutant IDH1 enzymes. The API synthesis involves advanced organic chemistry processes, including asymmetric synthesis and chiral purity control. Top suppliers in this domain generally include:

• Pfizer’s API Suppliers: While Pfizer originally developed the API, current sourcing details remain proprietary. However, Pfizer often utilizes specialized chemical manufacturers across Europe and Asia to produce API intermediates under contract manufacturing agreements.

• Contract Manufacturing Organizations (CMOs): Several CMOs with expertise in complex API synthesis supply APIs for oncology drugs, including those with advanced chiral chemistry capabilities, such as Lonza, Samsung Biologics, and WuXi AppTec.

• Raw Material Suppliers for API Synthesis: Suppliers providing specialized chemicals such as chiral catalysts, solvents, reagents, and intermediates are critical. Companies like Merck (MilliporeSigma), Thermo Fisher Scientific, and TCI Chemicals supply high-quality reagents used during synthesis.

Excipients and Formulation Components

The final oral dosage form of FYARRO requires excipients that ensure stability, bioavailability, and shelf-life. These may include:

• Fillers and Binders: Microcrystalline cellulose (supplier: FMC Corporation)
• Disintegrants: Croscarmellose sodium (supplier: Borregaard or FMC)
• Coating Agents: Hydroxypropyl methylcellulose (HPMC) supplied by Dow Chemical or Shin-Etsu
• Lubricants and Glidents: Magnesium stearate (supplier: Fletcher American Group)

Packaging Materials

Pharmaceutical-grade packaging materials are sourced from specialized suppliers to meet sterile and stability standards:

• Blister and Bottling Materials: Gerresheimer, Schott AG
• Tamper-evident and child-resistant caps: West Pharmaceutical Services

Manufacturing and Quality Control

The production of FYARRO involves contract manufacturing facilities compliant with Good Manufacturing Practices (GMP). These include:

• Contract Manufacturers: Firms like WuXi AppTec, Lonza, and Catalent manage scalable production while maintaining strict quality controls.

• Quality Control and Analytical Testing: Suppliers for analytical standards, reagents, and controls include companies such as MilliporeSigma and Thermo Fisher Scientific.

Distribution and Logistics

Post-manufacture, FYARRO is distributed globally through authorized logistics providers specializing in temperature-controlled shipments for biologics and highly potent drugs:

• Freight and Cold Chain Logistics: DHL Pharma Logistics, FedEx Custom Critical, and UPS Healthcare provide specialized services to preserve drug integrity during transit.

• Regional Distributors: Local distributors and wholesalers handle regional delivery, often managed by licensed pharmaceutical distribution firms aligned with international regulatory standards.

Regulatory and Supplier Certifications

Suppliers involved in FYARRO’s lifecycle must adhere to strict GMP, ISO standards, and pharmacopoeial regulations. Certification audits are routine, ensuring compliance with:

• FDA (U.S. Food and Drug Administration) standards
• EMA (European Medicines Agency) directives
• ICH (International Council for Harmonisation) guidelines

Emerging Trends and Risks

Dependence on overseas suppliers, especially in Asia and Europe, presents risks such as geopolitical disruptions, supply chain bottlenecks, and regulatory delays. To mitigate these, the pharmaceutical companies often develop multi-sourcing strategies and maintain buffer inventories.

Conclusion

The supply chain for FYARRO encompasses a network of specialized chemical suppliers, CMOs, formulation manufacturers, and logistics providers. Dominated largely by contract manufacturing and strategic sourcing, the industry's shift towards diversifying supplier bases aims to secure continuity and regulatory compliance. Given the critical nature of oncology therapeutics, ongoing evaluation of supplier quality and capacity remains paramount for stakeholders.

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Key Takeaways

• Critical Role of CMOs: Contract manufacturing organizations such as WuXi AppTec and Lonza are pivotal in FYARRO’s production, ensuring scalability and compliance.
• Supply Chain Risks: Over-reliance on Asian and European suppliers highlights the importance of supplier diversification and risk mitigation strategies.
• Regulatory Compliance: Suppliers must meet strict GMP and ISO standards; ongoing audits are essential for quality assurance.
• Innovative Sourcing Practices: Emerging trends favor multi-sourcing and regional suppliers to prevent disruptions.
• End-to-End Logistics: Temperature-sensitive distribution channels safeguard FYARRO’s integrity from manufacturing to patient delivery.

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FAQs

1. Who are the primary suppliers of the API for FYARRO?
   The API manufacturing involves contract manufacturing organizations such as WuXi AppTec and Lonza, sourcing specialized intermediates from leading chemical suppliers globally.

2. What are the main raw materials used in FYARRO production?
   High-purity reagents, chiral catalysts, solvents, and intermediates supplied by firms like MilliporeSigma and Thermo Fisher Scientific form the core raw materials.

3. How is quality maintained across the supply chain?
   Strict adherence to GMP standards, regular audits, and certification from agencies like the FDA and EMA ensure high-quality standards are maintained.

4. Are there regional suppliers involved in FYARRO's supply chain?
   Yes, many suppliers are based in Asia and Europe, emphasizing the importance of regional sourcing and diversified supply chains.

5. What measures are in place to mitigate supply chain disruptions?
   Multi-sourcing strategies, safety stock buffers, and regional manufacturing facilities help mitigate potential disruptions.

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Sources:

[1] Pharmaceutical industry reports on oncology drug supply chains.
[2] Company disclosures and contract manufacturing agreements (publicly available).
[3] Regulatory guidelines from FDA, EMA, and ICH standards.
[4] Industry insights from supply chain analysis publications.