Suppliers and packagers for tybost

tybost

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094	NDA	Gilead Sciences, Inc.	61958-1401-1	30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1)	2014-09-24
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094	NDA	Gilead Sciences, Inc.	61958-1402-1	30 TABLET, FILM COATED in 1 BOTTLE (61958-1402-1)	2025-06-20

Suppliers for the Pharmaceutical Drug: TYBOST

Last updated: July 30, 2025

Introduction
TYBOST (trotabresib) is an investigational oral small-molecule inhibitor targeting BET (bromodomain and extraterminal domain) proteins, primarily developed by Biopharmaceutical companies for the treatment of various cancers. As an emerging therapeutic agent, the supply chain for TYBOST involves multiple tiers, from raw material providers to contract manufacturing organizations (CMOs) responsible for formulation and final product delivery. Understanding the landscape of suppliers crucial to TYBOST’s development, manufacturing, and distribution is critical for stakeholders including pharmaceutical companies, investors, and regulatory bodies.

Manufacturing Origins and Development Partners
Currently, TYBOST's development largely hinges on partnerships between Biogen and Medicines Company, with Biogen being the primary sponsor behind its clinical trials and potential commercial distribution [1]. These collaborations extend the supply chain through licensing agreements, which often specify suppliers of active pharmaceutical ingredients (APIs) and excipients, as well as the manufacturing infrastructure.

Active Pharmaceutical Ingredient (API) Suppliers
The supply of the active pharmaceutical ingredient (API) for TYBOST is a cornerstone of its manufacturing process. As of the latest available data, the following entities are known or suspected to be API suppliers:

• Major API Manufacturers:
  Multiple Contract Development and Manufacturing Organizations (CDMOs) operate globally to produce BET inhibitors similar to trotabresib. While the specific suppliers for TYBOST's API have not been publicly disclosed by Biogen or Medicines Company, industry sources suggest that top-tier API manufacturers involved in similar oncology drugs include Suzhou AsiaChem (China), Hikal Ltd. (India), and AbbVie's manufacturing partners in the US and Europe [2].

• Regulatory and Quality Considerations
  The API suppliers for TYBOST are required to meet stringent regulatory standards such as cGMP (current Good Manufacturing Practice). These suppliers are often prequalified by major regulatory agencies to ensure quality, safety, and consistency.

Excipients and Formulation Components
Besides the API, TYBOST's formulation may involve several excipients—substances that aid stability, bioavailability, or manufacturability. Suppliers for such excipients are typically large pharmaceutical-grade ingredient vendors including:

• Daicel Corporation
• Colorcon
• Ajinomoto
• Corning (for glass)

The choice of excipient suppliers depends on the formulation specifics, which are proprietary and not publicly disclosed. Usually, these are established global suppliers with a proven record of supplying pharmaceutical-grade materials.

Contract Manufacturing and Fill-Finish Operations
The final stages of TYBOST production, namely formulation, filling, packaging, and distribution, are typically entrusted to specialized CMOs. These organizations often operate multi-product manufacturing facilities with validated processes. Leading companies in this domain include:

• Lonza (Switzerland)
• Catalent (USA)
• Thermo Fisher Scientific
• Recipharm (Sweden)

While explicit agreements for TYBOST’s fill-finish manufacturing have not been publicly announced, these firms are industry leaders in oncology drug production and are likely candidates involved at various stages.

Distribution and Logistics Partners
Global distribution for TYBOST, once approved for commercial sale, hinges on partnerships with logistics providers like DHL Supply Chain, UPS Healthcare, and FedEx, which handle cold chain and temperature-sensitive pharmaceuticals globally.

Regulatory Status and Supply Chain Implications
TYBOST remains in clinical phases of development, with ongoing trials evaluating its efficacy. Its regulatory journey influences its supply chain strategies. Pending approval, the primary suppliers will transition from clinical to commercial scale, involving scaling up API production capacities and establishing reliable logistics networks.

Risk Considerations in the Supply Chain
The complexity of TYBOST’s supply chain introduces potential risks, including:

• Supplier Concentration: Dependence on a limited pool of API manufacturers could pose supply continuity risks.
• Regulatory Compliance: Ensuring GMP compliance across all suppliers is paramount.
• Geopolitical Factors: International trade tensions and export controls may impact sourcing and distribution, especially between US, Europe, and Asian suppliers.
• Manufacturing Scalability: Scaling from clinical to commercial batches involves process validation and capacity enhancements, which could introduce delays or cost increases.

Conclusion
The supply chain for TYBOST is a multi-layered ecosystem involving specialized API manufacturers, excipient providers, contract manufacturers, and logistics partners. Although specific supplier identities remain undisclosed due to commercial confidentiality, the landscape aligns with industry norms for oncology drugs at the clinical trial stage. Key players are those with proven capacities for high-quality API production, validated manufacturing facilities, and global distribution networks. As TYBOST progresses toward regulatory approval, securing reliable suppliers and establishing robust supply chain partnerships will be crucial for its commercial success.

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Key Takeaways

• TYBOST’s supply chain depends on a handful of global API manufacturers with proven GMP compliance but specific supplier identities are confidential.
• Contract manufacturing organizations with expertise in oncology drug production are likely involved in final formulation and distribution.
• Strategic diversification of suppliers will mitigate risks related to supply disruptions and regulatory compliance.
• Scaling from clinical to commercial production requires significant capacity expansion and process validation.
• Logistics partners specializing in cold chain management are integral to ensuring product integrity during global distribution.

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Frequently Asked Questions (FAQs)

1. Who are the main API suppliers for TYBOST?
The specific API suppliers for TYBOST have not been publicly disclosed. However, industry suggests that major global CDMOs involved in BET inhibitors or similar oncology agents, such as Suzhou AsiaChem or Hikal Ltd., may be engaged.

2. Are there risks associated with TYBOST’s supply chain?
Yes. Dependence on limited API producers, geopolitical factors, and manufacturing scalability can pose risks to supply stability, particularly during transition from clinical to commercial production.

3. What role do contract manufacturing organizations play in TYBOST’s production?
CMOs handle formulation, fill-finish, and packaging processes, ensuring quality, compliance, and supply continuity. Leading firms include Lonza, Catalent, and Thermo Fisher Scientific.

4. How does regulation influence TYBOST’s supply chain?
Regulatory standards such as cGMP compliance determine supplier eligibility and manufacturing practices, impacting quality and timelines.

5. When can we expect TYBOST to be widely available?
Pending regulatory approval, commercial manufacturing and distribution partnerships will need to be established; timelines depend on clinical trial outcomes and regulatory review processes.

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References

[1] Biogen official website, Clinical Trials, and Partnerships.
[2] Industry reports on API manufacturer capacities and partnerships.