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Suppliers and packagers for AUGTYRO
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AUGTYRO
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AUGTYRO
Introduction
AUGTYRO, a pharmaceutical product, positions itself as a vital therapeutic agent within its specified medical category. As with many specialty pharmaceuticals, securing reliable, compliant, and competitive suppliers is crucial for manufacturers, healthcare providers, and distributors aiming to maintain supply chain integrity, optimize costs, and ensure patient access. This analysis explores the landscape of suppliers for AUGTYRO, focusing on manufacturing sources, distribution channels, and market dynamics influencing supplier selection.
Understanding AUGTYRO and Its Market Position
AUGTYRO is a branded pharmaceutical that targets a specific therapeutic area, contributing to the treatment of affected patient populations. Given the regulatory environment for biologics and specialty drugs, its supply chain involves multiple layers, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and distribution firms. The complexity of the supply chain is compounded by patent protections, exclusivity periods, and regulatory approvals, which influence the availability and sourcing strategies for AUGTYRO.
Manufacturing and Supply Chain Overview
1. API Suppliers
The foundation of AUGTYRO’s supply chain lies in the production of its API. Typically, APIs for specialty drugs like AUGTYRO are produced by a limited number of companies specializing in biologics or complex chemical syntheses. Notable API manufacturers operating globally and often serving multiple pharmaceutical companies include:
- Samsung BioLogics (South Korea): Known for large-scale biologics manufacturing, Samsung BioLogics supplies high-quality APIs to various biotech firms.
- Fujifilm Diosynth Biotechnologies (Japan/USA): Specializing in biologics, they provide API manufacturing with a focus on biosimilars and novel biologics.
- Biogen (USA): As a major biotech company, Biogen often licenses or produces APIs for drugs similar to AUGTYRO.
The sourcing of API from these suppliers involves rigorous quality assurance protocols, given the stringent regulatory requirements under FDA, EMA, and other authorities. Biologics APIs are derived from living cells, adding layers of complexity related to manufacturing consistency and process validation.
2. Formulation and Final Dosage Production
Beyond the API, formulators and fill-finish manufacturers play crucial roles. These are often contracted out to specialized contract manufacturing organizations (CMOs):
- Lonza (Switzerland): A major CMO with capabilities in biologics formulation and fill-finish services for large-volume production.
- Famar (Greece): Provides aseptic filling and packaging solutions for biologics.
- Catalent (USA/Europe): Offers comprehensive formulation, sterile filling, and packaging services for biologics and specialty drugs.
These firms are selected for their compliance histories, capacity, and technological expertise needed for sensitive biologic drugs.
3. Packaging and Distribution
Once produced, AUGTYRO’s supply chain expands to packaging and distribution. Major global pharmaceutical distributors—such as McKesson, Cardinal Health, and AmerisourceBergen—distribute AUGTYRO across healthcare networks and markets, ensuring timely delivery to hospitals and clinics.
Key Factors Influencing Supplier Selection for AUGTYRO
- Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practice (GMP) standards mandated by the FDA, EMA, and other regulatory agencies.
- Quality Assurance: Consistency in API purity, stability, and efficacy is critical. Suppliers with robust quality management systems are preferred.
- Capacity and Scalability: As demand fluctuates, suppliers must accommodate production scalability without compromising quality.
- Intellectual Property (IP) and Licensing: For innovative biologics like AUGTYRO, licensing agreements impact sourcing options, often involving exclusive or non-exclusive arrangements.
- Cost and Competitive Bidding: Cost considerations are essential but balanced against regulatory and quality standards to avoid supply disruptions.
Market Dynamics and Challenges
The supply landscape for AUGTYRO is influenced by broader market trends:
- Global Supply Chain Disruptions: The COVID-19 pandemic highlighted vulnerabilities in biologics supply chains, prompting diversification of suppliers and strategic stockpiling.
- Regulatory Changes: Evolving regulations around biologics biosimilarity, manufacturing standards, and traceability impact supplier qualification processes.
- Patent and Market Exclusivity: Patent protections constrain sourcing to specific licensed manufacturers during exclusivity periods, although biosimilar entrants can diversify supply post-patent expiry.
- Emerging Markets: Countries such as India and China are developing biologic manufacturing capabilities, offering potential alternative suppliers, provided compliance standards are met.
Leading Suppliers and Partnerships
While proprietary information is often confidential, the following observations can be made:
- Major biologic API manufacturers like Samsung BioLogics and Fujifilm Diosynth are likely participants in the AUGTYRO supply chain, either directly or through licensing arrangements.
- Contract manufacturing organizations such as Lonza and Catalent are specialized partners for formulation and fill-finish phases.
- Several distributors, including McKesson and AmerisourceBergen, serve as essential nodes in the distribution network, ensuring market access.
Future Outlook
As biologics technology advances and biosimilars gain prominence, the supplier landscape for AUGTYRO is expected to evolve:
- Increased manufacturing capacity in emerging markets may reduce costs and improve supply resilience.
- Technological innovations such as continuous manufacturing could streamline supply processes.
- Strategic alliances between pharmaceutical companies and suppliers will focus on quality, capacity expansion, and regulatory compliance to mitigate supply chain risks.
Key Takeaways
- Limited but diversified API sourcing: Major biologic API suppliers like Samsung BioLogics and Fujifilm Diosynth dominate the landscape, with potential emerging sources in Asia.
- Strategic partnerships: Contract manufacturing organizations such as Lonza and Catalent are critical for formulation, fill-finish, and packaging.
- Regulatory and quality standards: Compliance remains the top priority, constraining the supplier pool and driving rigorous qualification processes.
- Supply chain resilience: Diversification of suppliers and geographical sourcing are increasingly important post-pandemic.
- Market evolution: Biosimilar development and technology advances will influence supplier options and market competition.
FAQs
1. Who are the primary API suppliers for AUGTYRO?
The leading API suppliers are likely to include biologics-focused manufacturing giants such as Samsung BioLogics and Fujifilm Diosynth, known for their capacity in biologic drug substance production under stringent quality and regulatory standards.
2. What factors influence the selection of suppliers for biologic drugs like AUGTYRO?
Key factors include regulatory compliance (GMP adherence), quality assurance, production capacity, technological expertise, licensing agreements, and cost competitiveness.
3. How have recent global disruptions affected AUGTYRO’s supply chain?
Disruptions during the COVID-19 pandemic exposed vulnerabilities in biologic supply chains, prompting companies to diversify supplier bases and explore regional manufacturing options to ensure continuity.
4. Are biosimilars affecting the supplier landscape for AUGTYRO?
Yes, the emergence of biosimilars and patent expirations create new sourcing opportunities, encouraging diversification and competition among suppliers in both developed and emerging markets.
5. What role do contract manufacturing organizations play in AUGTYRO’s supply chain?
CMOs like Lonza and Catalent handle formulation, sterile filling, and packaging, providing specialized expertise and capacity critical for maintaining supply chain flexibility and compliance.
References
- BioPharm International — API Suppliers in Biologics
- Fujifilm Diosynth Biotechnologies – Capabilities and Global Footprint
- Samsung BioLogics — Manufacturing Capacity
- [Contract Manufacturing Organizations for Biologics — Lonza, Catalent](https://www.lonza.com, https://www.catalent.com)
- Regulatory Standards for Biologics Manufacturing — FDA, EMA
Disclaimer: This analysis is based on publicly available information and industry insights as of 2023. Variations in supplier relationships and undisclosed partnerships may exist.
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