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Suppliers and packagers for krazati
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krazati
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 | KRAZATI | adagrasib | TABLET;ORAL | 216340 | NDA | Mirati Therapeutics, Inc | 80739-812-12 | 1 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE | 2022-12-12 |
| Bristol | KRAZATI | adagrasib | TABLET;ORAL | 216340 | NDA | Mirati Therapeutics, Inc | 80739-812-18 | 1 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLE | 2022-12-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: KRAZATI
Introduction
KRAZATI, an orally administered targeted therapy, has gained prominence in oncology treatment due to its efficacy in managing specific cancer types. As a precision medicine, its commercial success hinges on the robustness and reliability of its supply chain. Identifying and understanding the suppliers behind KRAZATI is crucial for stakeholders, including manufacturers, healthcare providers, and investors, to assess market stability, supply chain risks, and potential expansion opportunities.
Overview of KRAZATI
KRAZATI (generic name: adagrasib) is developed by Mirati Therapeutics, approved by the FDA for the treatment of certain solid tumors, particularly non-small cell lung cancer (NSCLC) harboring specific mutations such as KRAS G12C. Its unique mechanism targets the KRAS G12C mutation, a prominent driver in various tumor types.
The drug's manufacturing process involves complex organic synthesis, high-quality biologics handling, and stringent quality controls, making its supply chain sensitive to disruptions at multiple points, from raw material sourcing to final distribution.
Raw Material Suppliers
The manufacturing of adagrasib relies on several specialized raw materials, including proprietary active pharmaceutical ingredients (APIs), excipients, and specialized solvents.
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Active Pharmaceutical Ingredient (API): The core component of KRAZATI, adagrasib's API synthesis involves multi-step chemical processes requiring high-purity chemical precursors. Major suppliers of these chemical precursors are typically niche chemical manufacturers in Asia and Europe, with companies like CS Bio Co., Ltd., and Jiangsu Hengrui Medicine Co., leading in chemical synthesis for oncology drugs.
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Excipients: Stabilizers, fillers, and binders are sourced from established excipient manufacturers such as Evonik Industries and Jubilant Life Sciences, which provide pharmaceutical-grade excipients compliant with regulatory standards.
Manufacturing Facilities and Contract Manufacturers
Mirati Therapeutics primarily oversees API synthesis and drug formulation through its proprietary manufacturing units; however, it extensively leverages Contract Manufacturing Organizations (CMOs).
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API Production: Key API manufacturing is often outsourced to facilities in India and China, benefiting from cost efficiencies and established pharmaceutical manufacturing expertise. Leading CMOs include Jubilant HollisterStier and Jiangsu Hengrui Pharmaceutical Co., which possess Good Manufacturing Practice (GMP) certifications for oncology APIs.
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Final Dosage Form: The formulation, encapsulation, and packaging processes are frequently contracted to reputable pharmaceutical CDMOs such as Thermo Fisher Scientific and Catalent, known for their high-quality sterile and non-sterile formulations.
Distribution and Logistics Providers
Supply chain resilience also depends on robust distribution networks. Global logistics companies like DHL, FedEx, and UPS handle temperature-sensitive transportation of KRAZATI to ensure stability and compliance with regulatory standards.
- Cold chain logistics is critical given the stability profile of adagrasib, emphasizing the role of specialized providers such as World Courier and National Refrigerated Logistics.
Regulatory and Quality Conformity
Suppliers and manufacturing partners must meet stringent FDA, EMA, and PMDA regulatory standards. Certification audits and continuous quality assurance are critical components of the supply chain integrity.
Market Dynamics and Supply Chain Risks
The limited number of specialized suppliers for high-potency oncology APIs like adagrasib introduces potential risks:
- Supply Disruption Risks: Over-reliance on single-source suppliers can lead to shortages if unforeseen disruptions occur.
- Price Volatility: Limited supplier competition may influence API and excipient pricing, affecting manufacturing costs.
- Regulatory Risks: Non-compliance or delays in certification can impede supply continuity.
Therefore, manufacturers actively seek diversified supplier bases and backup plans to mitigate these vulnerabilities.
Emerging Suppliers and Market Competition
The positive outlook for KRAS G12C inhibitors like KRAZATI has spurred new entrants and existing pharmaceutical companies to bolster their supply chains:
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Emerging API Manufacturers: Companies in Southeast Asia and Eastern Europe are expanding capabilities, with notable players such as Sino Biopharmaceutical and Dr. Reddy's Laboratories increasing their role in oncology API supply.
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Strategic Partnerships: Mirati Therapeutics has engaged with multiple CMOs to diversify supply sources, including collaborations with Alcami Corporation and PCI Synthesis.
Conclusion
The suppliers behind KRAZATI encompass a specialized network of chemical manufacturers, CMOs, excipient providers, and logistics companies. The complexity of adagrasib’s manufacturing process underscores the importance of supply chain diversification and rigorous quality management. As demand for KRAS-targeted therapies grows, securing a resilient and scalable supply chain remains vital for sustaining market growth and ensuring patient access.
Key Takeaways
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Supply chain robustness for KRAZATI hinges on a limited number of specialized suppliers, primarily in Asia and Europe. Diversification of sources mitigates risks associated with geopolitical, manufacturing, or regulatory disruptions.
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Strategic partnerships with CMOs are central to scaling production, maintaining quality, and ensuring timely delivery.
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Active engagement with logistics providers specializing in sensitive pharmaceutical shipping safeguards drug stability.
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Emerging players and new supplier entrants signal increasing capacity and competition, potentially influencing pricing and supply stability.
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Regulatory compliance remains a critical focus, with suppliers required to demonstrate GMP certification, quality assurance, and transparency.
FAQs
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Who are the primary API suppliers for KRAZATI?
The main API manufacturing partners are established chemical synthesis companies in China and India, such as Jiangsu Hengrui Pharmaceutical and Jubilant HollisterStier, which produce adagrasib’s active ingredient under strict GMP standards. -
Are there alternative suppliers for adagrasib’s raw materials?
Yes, while current supply chains rely heavily on certain suppliers, newer entrants in Southeast Asia and Eastern Europe are expanding their capabilities, offering potential alternatives and increasing overall supply security. -
What role do Contract Manufacturing Organizations play in KRAZATI’s supply chain?
CMOs handle formulation, encapsulation, packaging, and final distribution logistics, providing manufacturing scalability and flexibility essential for meeting global demand. -
What risks are associated with KRAZATI’s supply chain?
Risks include dependency on limited suppliers, geopolitical factors affecting manufacturing, regulatory delays, and logistical challenges, particularly in cold chain management. -
How is supply chain resilience being improved for KRAZATI?
Companies are diversifying supplier relationships, establishing contingency plans, investing in technological enhancements, and engaging multiple CMOs and logistics providers to mitigate vulnerabilities.
References
[1] Mirati Therapeutics. (2022). KRAZATI (adagrasib) prescribing information.
[2] FDA. (2021). KRAZATI approval announcement.
[3] PharmSource. (2022). Oncology API sourcing trends.
[4] World Courier. (2021). Cold chain logistics for oncology drugs.
[5] European Medicines Agency. (2022). Regulations on pharmaceutical supply chains.
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