Suppliers and packagers for generic pharmaceutical drug: REPOTRECTINIB

REPOTRECTINIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213	NDA	E.R. Squibb & Sons, L.L.C.	0003-4040-12	120 CAPSULE in 1 BOTTLE (0003-4040-12)	2023-12-05
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213	NDA	E.R. Squibb & Sons, L.L.C.	0003-4040-60	60 CAPSULE in 1 BOTTLE (0003-4040-60)	2023-12-05
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213	NDA	E.R. Squibb & Sons, L.L.C.	0003-4160-14	14 CAPSULE in 1 BOTTLE (0003-4160-14)	2024-11-01
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213	NDA	E.R. Squibb & Sons, L.L.C.	0003-4160-60	60 CAPSULE in 1 BOTTLE (0003-4160-60)	2024-11-01

Suppliers for the Pharmaceutical Drug: REPOTRECTINIB

Last updated: July 30, 2025

Introduction

Repotrectinib, also known by its development code TPX-0005, is an innovative targeted cancer therapy developed by Arete Bio and associated pharmaceutical entities. It functions as a tyrosine kinase inhibitor targeting ROS1, NTRK, and ALK gene alterations — mutations commonly involved in various solid tumors, notably non-small cell lung cancer (NSCLC). Its potential for overcoming resistance mechanisms in targeted therapy has spurred significant interest in production, sourcing, and supply chain logistics. This article comprehensively explores the suppliers involved in the manufacturing, distribution, and commercialization of repotrectinib, providing actionable insights for stakeholders.

Manufacturers of Repotrectinib

1. Arete Bio (Primary Developer)

Arete Bio initiated clinical development of repotrectinib, conducting early-phase trials and establishing initial manufacturing protocols. As a biotech company, Arete Bio is primarily responsible for phase-appropriate manufacturing and supply chain arrangements for clinical trials. While their focus remains on clinical supply, they have partnered with contract manufacturing organizations (CMOs) for large-scale production.

2. Contract Manufacturing Organizations (CMOs)

Clinical-stage drugs like repotrectinib are typically produced in partnership with specialized CMOs that handle pharmaceutical synthesis, formulation, and packaging under cGMP standards.

• Thermo Fisher Scientific
  A leading provider in biopharmaceutical manufacturing services, Thermo Fisher Scientific often supports Phase I and Phase II clinical supplies for novel therapeutics. Their capabilities include small molecule synthesis, formulation, and packaging.

• Samsung Biologics
  Known primarily for biologics, Samsung extends its manufacturing services to small molecules through partnerships, offering scalable production capabilities for early to late-stage clinical trials.

• Lonza
  Specialized in small molecule manufacturing, Lonza provides process development and commercial manufacturing solutions, including active pharmaceutical ingredient (API) synthesis and formulation.

• Catalent and Patheon (a part of Thermo Fisher)
  These organizations offer comprehensive formulation, fill-finish, and manufacturing services for clinical and commercial supplies.

3. Commercial Production and Supply

Following successful clinical trials and regulatory approval, the production of repotrectinib, if pursued for commercialization, would likely involve larger pharmaceutical manufacturers or licensing partners.

• Partnered Pharmaceutical Companies
  Once repotrectinib advances toward approval, major pharmaceutical firms with significant manufacturing capacity—such as Pfizer, Novartis, or Roche—may become involved either through in-house manufacturing or licensing arrangements.

• Licensees and Distributors
  Depending on geographic regions, regional licensees and distributors could emerge as key suppliers, especially in markets like China, India, and Europe. These entities often contract with primary manufacturers or import finished API or formulation.

Supply Chain Dynamics and Key Suppliers

Active Pharmaceutical Ingredients (API) Suppliers

The foundation of repotrectinib’s supply chain hinges on sourcing high-quality APIs. While the specific API producers are often proprietary or confidential during early development stages, several generic and niche API suppliers could be involved:

• Sinon Biotech
  An emerging API manufacturer with experience producing kinase inhibitors.

• Hovid Inc.
  Known for generic API manufacturing, potentially supplying intermediates or raw materials used in repotrectinib synthesis under contract.

• Robust API manufacturers in India and China
  Countries like India (e.g., Sun Pharmaceutical, Dr. Reddy’s Laboratories) and China host numerous API producers capable of synthesizing complex kinase inhibitors, contingent on licensing and technology transfer agreements.

Excipient and Packaging Suppliers

In addition to APIs, the supply chain depends on excipients for formulations:

• DuPont Nutrition & Health
  Provides pharmaceutical-grade excipients for drug formulation.

• Catalent and Siegfried
  Offer formulation services, including tablets, capsules, or infusion preparations, with global distribution channels.

Distribution and Logistics

Post-manufacturing, repotrectinib’s distribution involves cold chain logistics if required and compliance with international regulations, especially for oncologic agents.

• DHL Healthcare, FedEx, and specialized pharmaceutical logistics providers manage global distribution, ensuring compliance with Good Distribution Practices (GDP).

• Regional distributors: In collaboration with regulatory approvals, regional distributors partner with manufacturers to facilitate access across different markets.

Regulatory and Licensing Impacts on Supply

Regulatory approvals strongly influence the supply chain, determining manufacturing scale and distribution scope. As of 2023, repotrectinib has been in clinical trials, with ongoing data collection for potential regulatory submissions.

• Regulatory agencies such as the FDA, EMA, and NMPA impose stringent manufacturing standards, often requiring certification from inspected CMOs.

• Licensing agreements with local firms can accelerate distribution, especially in regions with emerging markets for targeted therapies.

Emerging Market Opportunities

The commercial success of repotrectinib hinges on securing reliable, scalable suppliers and establishing robust logistics networks.

• Asia-Pacific (India, China, Japan): Countries with established pharmaceutical manufacturing ecosystems, capable of cost-effective production under license.

• Europe and North America: Preference for high-quality, certified suppliers conforming to Good Manufacturing Practices (GMP).

• Global supply chain resilience will be vital to mitigate risks related to geopolitical variability, pandemic disruptions, and raw material shortages.

Conclusion

Repotrectinib’s supply chain involves a complex network of developers, CMOs, API producers, formulation specialists, and logistics providers. While primary development remains with Arete Bio, scaling for commercial production will necessitate strategic partnerships with established global manufacturers. Understanding the interplay between clinical-stage suppliers and later-stage manufacturing is imperative for stakeholders aiming to navigate the evolving landscape of targeted cancer therapies.

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Key Takeaways

• Primary developers like Arete Bio contract with specialized CMOs (e.g., Thermo Fisher, Lonza) for clinical and potential commercial manufacturing.

• API sourcing is likely from high-quality, globally recognized producers in India, China, or licensed domestic manufacturers.

• Regulatory standards dictate manufacturing practices, impacting supplier selection and quality assurance.

• Global distribution networks must be robust, compliant with GDP, and prepared for regional licensing and commercialization.

• Strategic partnerships and licensing agreements are critical to expand access and ensure supply chain resilience during commercial rollout.

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FAQs

1. Who are the main API suppliers for repotrectinib?

While specific API manufacturers are proprietary, potential suppliers include established pharmaceutical API producers in India, China, and specialized biotech firms capable of synthesizing kinase inhibitors under licensing agreements.

2. What CMOs are involved in repotrectinib production?

Leading CMOs such as Thermo Fisher Scientific, Lonza, and Catalent are equipped to support clinical and commercial manufacturing, pending partnership agreements.

3. When is repotrectinib expected to reach the market?

As of 2023, repotrectinib is still in clinical trials; its commercial launch is contingent on successful trial outcomes, regulatory review, and manufacturing scale-up.

4. How does regulatory compliance influence repotrectinib supply?

Manufacturers must adhere to GMP standards mandated by agencies like the FDA and EMA, influencing supplier selection and quality assurance processes.

5. Are there regional differences in repotrectinib supply chains?

Yes. Developed markets favor high-certification suppliers with strict GMP compliance, whereas emerging markets may rely on licensed regional manufacturers to facilitate access.

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References

[1] Arete Bio. “Repotrectinib: Development and Clinical Status,” clinicaltrials.gov, 2023.
[2] Pharma intelligence reports on kinase inhibitors manufacturing capacities.
[3] WHO guidelines on Good Manufacturing Practices (GMP).
[4] Industry reports on API manufacturing hubs in Asia.