Suppliers and packagers for generic pharmaceutical drug: trilaciclib dihydrochloride

trilaciclib dihydrochloride

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

Suppliers for the Pharmaceutical Drug: Trilaciclib Dihydrochloride

Last updated: July 31, 2025

Introduction

The rising complexity of oncology treatments has elevated the importance of targeted supportive drugs like Trilaciclib Dihydrochloride. This CDK4/6 inhibitor, designed to protect hematopoietic stem and progenitor cells during chemotherapy, has garnered substantial interest among pharmaceutical manufacturers and healthcare providers. Identifying reliable suppliers of Trilaciclib Dihydrochloride is crucial for companies seeking to ensure supply chain integrity, compliance, and cost efficiency. This article provides a comprehensive overview of current suppliers, manufacturing landscape, and sourcing strategies associated with Trilaciclib Dihydrochloride.

Market Overview and Significance

Trilaciclib Dihydrochloride, approved by the FDA in 2021 for reducing chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer (ES-SCLC), exemplifies precision pharmaceutical innovation. Its niche positioning dictates that the pool of suppliers is relatively limited, typically involving established APIs (Active Pharmaceutical Ingredients) manufacturers with specialized capabilities in CDK inhibitors and complex molecules.

Leading Suppliers and Manufacturers

1. Eli Lilly and Company

Eli Lilly is the innovator behind Trilaciclib, securing FDA approval and leading the commercial production in-house. The pharmaceutical giant commits substantial resources to ensure supply stability, leveraging its integrated manufacturing facilities. While Eli Lilly primarily handles distribution, it may collaborate with authorized CDMO (Contract Development and Manufacturing Organization) partners—especially for API production and formulation scaling.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity and regulatory demands, Eli Lilly partners with select CMOs for API synthesis and manufacturing. These third-party producers often cater exclusively to licensed patent holders, ensuring high-quality standards in compliance with cGMP (current Good Manufacturing Practice). Notable CMOs in the API space include:

• Thermo Fisher Scientific: Known for high-quality API synthesis with capabilities tailored toward complex small molecules.
• R-Pharm: A Russian-based CMO specializing in niche APIs for oncology drugs, including cyclin-dependent kinase inhibitors.
• Samsung Biologics: While primarily focused on biopharmaceuticals, Samsung has expanded into complex small molecule manufacturing, potentially serving as an API supplier.

3. Chinese and Indian API Manufacturers

Global sourcing of active pharmaceutical ingredients has increasingly relied on China and India due to cost advantages and manufacturing capacity. Several manufacturers operate under strict quality control frameworks to supply Trilaciclib Dihydrochloride APIs:

• Haimen R&Y Pharmaceutical Co., Ltd. (China)
• Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
• Granules India Limited (India)
• Jiangsu Hengrui Medicine Co., Ltd. (China)

However, due to the novelty of Trilaciclib, many of these manufacturers are either in early production phases or preparing for GMP certification.

4. Emerging and Future Suppliers

The niche status of Trilaciclib Dihydrochloride indicates that new entrants are likely to emerge as demand scales. Companies with existing expertise in CDK inhibitors or similar kinase inhibitors are poised to expand their offerings. Key players preparing for this include:

• Sai Life Sciences
• Adept Laboratories
• Lonza

These organizations may, upon securing necessary regulatory clearances, become volume suppliers in the near future.

Sourcing Strategies and Considerations

• Quality and Regulatory Compliance: The primary determinant for supplier selection is adherence to cGMP standards and regulatory certifications. Countries with robust regulatory oversight, such as the US, EU, and Japan, are preferred sourcing regions.

• Supply Chain Stability: Given the critical nature of Trilaciclib in supportive care, companies must assess suppliers' manufacturing capacity and contingency plans to mitigate shortages.

• Cost & Lead Times: While cost is relevant, it must be balanced against quality assurance. Lead times can vary based on the complexity of synthesis, regulatory approval, and international shipping.

• Partnerships & Licensing Agreements: Established pharmaceutical companies often engage in licensing arrangements or direct partnerships with API manufacturers to ensure end-to-end control.

Regulatory Dynamics and Global Supply Chain

The global landscape for Trilaciclib Dihydrochloride suppliers is influenced by regulations such as the US FDA’s Drug Master Files (DMFs) and equivalent certifications in other regions. Manufacturers frequently submit DMFs to facilitate regulatory approval and ensure seamless audits. As the drug’s market expands, expect increased scrutiny and a push toward in-house or geographically diversified API production to ensure supply security.

Conclusion

The supplier ecosystem for Trilaciclib Dihydrochloride primarily revolves around Eli Lilly's internal manufacturing, complemented by a select cadre of CMOs and global API manufacturers. The limited supplier base underscores the need for strategic sourcing, emphasizing regulatory compliance, quality, and supply chain resilience. Companies planning to incorporate Trilaciclib into their formulations should prioritize suppliers with proven GMP credentials and reliable production capacities, while remaining vigilant to emerging players as demand increases.

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Key Takeaways

• Eli Lilly manages primary production; partnerships with specialized CMOs and API manufacturers support external supply needs.
• Chinese and Indian API manufacturers are potential sourcing candidates but require rigorous validation to meet regulatory standards.
• Supply chain resilience depends on diversification, quality assurance, and regulatory transparency of suppliers.
• Emerging manufacturers in the CDK inhibitor space may become key players as the drug’s market expands.
• Due diligence, including audits and regulatory review, is essential before engaging new suppliers for Trilaciclib API.

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Frequently Asked Questions (FAQs)

1. What are the main criteria when selecting a supplier for Trilaciclib Dihydrochloride?
   Quality assurance, GMP compliance, regulatory certifications, manufacturing capacity, and supply chain stability are critical criteria.

2. Are there alternative suppliers outside Eli Lilly’s network for Trilaciclib API?
   While Eli Lilly controls the primary manufacturing, several CMOs and API manufacturers, mainly in China and India, are potential sourcing options subject to qualification and regulatory approval.

3. How does global regulation impact the sourcing of Trilaciclib Dihydrochloride?
   Stringent compliance requirements, such as FDA DMFs and EMA certifications, influence supplier selection; suppliers must demonstrate robust quality systems and regulatory adherence.

4. What trends are shaping the Trilaciclib API supply landscape?
   Growing demand and market expansion may lead to increased manufacturing capacity, with emerging players from Asia and biotech-focused CMOs entering the market.

5. Is future supply diversification necessary for companies using Trilaciclib?
   Yes, diversification minimizes risks related to manufacturing bottlenecks or geopolitical disruptions, ensuring consistent availability for critical oncology support therapy.

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Sources

[1] Food and Drug Administration. “FDA Approves Trilaciclib for Chemotherapy-Induced Myelosuppression.” 2021.
[2] Eli Lilly and Company. “Trilaciclib Product Information.” 2022.
[3] PharmSource. “API Supply Chain & Regulatory Compliance Reports.” 2022.
[4] Frost & Sullivan. “Global CDK Inhibitors Market Analysis.” 2022.
[5] industry reports on Chinese and Indian API manufacturers’ capabilities and certifications.