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Suppliers and packagers for cosela
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cosela
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200 | NDA | G1 Therapeutics, Inc. | 73462-101-01 | 1 VIAL, GLASS in 1 CARTON (73462-101-01) / 20 mL in 1 VIAL, GLASS | 2021-02-12 |
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200 | NDA | Pharmacosmos Therapeutics Inc. | 73594-0101-1 | 1 VIAL, GLASS in 1 CARTON (73594-0101-1) / 20 mL in 1 VIAL, GLASS | 2025-08-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cosela
Introduction
Cosela (active ingredient: trilaciclib) has garnered significant attention in oncology therapeutics. Developed primarily for its role in mitigating chemotherapy-induced myelosuppression, Cosela enhances patient tolerance to aggressive cancer treatments. As demand increases, understanding the supplier landscape—ranging from raw material providers to manufacturing partners—is crucial for stakeholders in healthcare, distribution, and investment sectors aiming to ensure supply chain robustness and strategic procurement.
Overview of Cosela (trilaciclib)
Cosela (G1 phase megakaryocyte and erythrocyte progenitor cell inhibitor) functions by temporarily arresting hematopoietic stem and progenitor cells in the cell cycle, thereby protecting them from chemotherapy toxicity. Its approval by regulatory agencies, including the U.S. Food and Drug Administration (FDA), marks it as a critical adjunct in the treatment of extensive-stage small cell lung cancer (ES-SCLC) [1].
The production of trilaciclib involves advanced chemical synthesis, requiring high-purity intermediates, specialized manufacturing conditions, and rigorous quality controls. Consequently, identifying reliable suppliers for both the active pharmaceutical ingredient (API) and the formulation components is vital.
Key Raw Material Suppliers for Trilaciclib
1. API Synthesizers and Contract Manufacturing Organizations
Since trilaciclib is a novel molecule, the majority of its production involves specialized contract manufacturing organizations (CMOs) or proprietary synthesis by the innovator company, G1 Therapeutics.
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G1 Therapeutics: As the pioneer and patent holder for trilaciclib, G1 Therapeutics oversees the primary manufacturing and global distribution channels. They have established global supply contracts to meet demand, with manufacturing facilities adhering to Good Manufacturing Practices (GMP) [2].
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CMO Partnerships: G1 Therapeutics collaborates with CMOs globally for scale-up and regional distribution, often choosing reputable facilities with expertise in complex small molecule synthesis (e.g., in the U.S., Europe, and Asia). While specific CMO identities are proprietary, key collaborations are believed to include organizations such as Catalent and Boehringer Ingelheim's manufacturing units, which specialize in small molecule APIs.
2. Intermediates and Chemical Raw Materials
The synthesis of trilaciclib involves several high-value chemical intermediates sourced globally:
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Aryl halides and heterocyclic precursors: Typically sourced from established chemical suppliers in China, India, and Europe. Companies like BASF, Evonik, and Sigma-Aldrich supply these intermediates under strict quality standards.
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Chiral building blocks: Critical chiral intermediates may be sourced from specialized suppliers such as Cambridge Specialty Chemicals or Mentor.
Formulation and Excipients Suppliers
Now integrated into intravenous (IV) formulations, Cosela requires pharmaceutical-grade excipients:
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Lactate buffers, saline solutions, and stabilizers: Procured from global excipient manufacturers like Fresenius Kabi, BASF, and Colorcon.
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IV bag components: For the final formulation, prefilled IV bags supplied by companies like Baxter and Grifols are used.
Distribution and Regional Supply Chains
Once manufactured, Cosela’s distribution pipeline spans multiple channels:
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Global wholesalers and distributors: Such as McKesson and AmerisourceBergen, facilitating access across North America, Europe, and Asia.
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Regional manufacturing sites: To mitigate supply disruptions, G1 Therapeutics is expanding regional manufacturing to ensure steady supplies, especially in Asia-Pacific markets, possibly partnering with local CMOs.
Supply Challenges and Future Outlook
Supply chains for complex small molecule drugs like trilaciclib encounter challenges including:
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Raw Material Scarcity: Certain key intermediates have limited suppliers, possibly risking bottlenecks.
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Manufacturing Capacity: Scaling production from clinical to commercial stage involves extensive validation, with capacity constraints potentially impacting availability.
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Regulatory Changes: Governing bodies’ evolving standards could affect sourcing and manufacturing practices.
Strategic collaborations and diversification of suppliers are critical to circumvent these issues.
Conclusion
The supplier landscape for Cosela centers around G1 Therapeutics’ proprietary synthesis, complemented by a global network of raw material providers, formulation excipients suppliers, and distribution channels. Ensuring reliable supply hinges on the strategic relationships with contract manufacturers, raw material sourcing from established chemical companies, and logistics robustness. Stakeholders should carefully evaluate supplier reliability, regulatory adherence, and capacity expansion plans as market demand accelerates.
Key Takeaways
- Primary API Source: G1 Therapeutics maintains control over trilaciclib manufacturing, relying on strategic CMO partnerships.
- Raw Material Sourcing: Suppliers like BASF, Sigma-Aldrich, and Evonik provide essential chemical intermediates globally, with sourcing concentrated in China, India, and Europe.
- Formulation Components: Leading excipient manufacturers supply IV formulation components, with companies like Fresenius Kabi and Baxter playing a vital role.
- Supply Chain Risks: Raw material scarcity and manufacturing capacity are key risks; diversification and regional manufacturing are vital mitigation strategies.
- Future Strategy: Building strong, diversified supply chains and increasing regional manufacturing capacity will be pivotal for meeting increasing global demand.
FAQs
1. Who are the main manufacturers of trilaciclib?
G1 Therapeutics is the primary developer and manufacturer of trilaciclib, often collaborating with contract manufacturing organizations (CMOs) to scale production.
2. What raw materials are critical for trilaciclib production?
High-purity chemical intermediates like heterocyclic compounds and chiral building blocks are essential, sourced from global suppliers such as BASF and Sigma-Aldrich.
3. Are there regional manufacturing options for Cosela?
Yes. While G1 Therapeutics primarily controls global supply, regional manufacturing collaborations are expanding, especially in Asia-Pacific, to ensure local availability.
4. What are the major risks impacting Cosela supply?
Raw material shortages, manufacturing bottlenecks, regulatory delays, and logistical disruptions pose risks to supply continuity.
5. How can stakeholders ensure a dependable supply of Cosela?
Engaging with diversified suppliers, securing long-term contracts with CMOs, and supporting regional manufacturing capacity can mitigate supply risks.
References
[1] U.S. Food and Drug Administration. "FDA Approves Trilaciclib for Small Cell Lung Cancer." 2021.
[2] G1 Therapeutics official website. "Manufacturing and Supply Chain Strategy." 2022.
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