Suppliers and packagers for cinvanti

cinvanti

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296	NDA	Heron Therapeutics, Inc.	47426-201-01	1 VIAL, GLASS in 1 CARTON (47426-201-01) / 18 mL in 1 VIAL, GLASS	2018-01-03

Suppliers for the Pharmaceutical Drug: CINVANTI

Last updated: August 6, 2025

Introduction

CINVANTI (aprepitant), marketed by Heron Therapeutics, Inc., is a highly specialized antiemetic used predominantly for preventing chemotherapy-induced nausea and vomiting (CINV). As a long-acting neurokinin-1 receptor antagonist (NK1-RA), CINVANTI plays a crucial role in supportive cancer care. Its manufacturing involves complex synthesis and sourcing of high-purity active pharmaceutical ingredients (APIs), raw materials, and advanced formulation components. Identifying and understanding the key suppliers across the supply chain is essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors, to assess supply chain stability, cost efficiencies, and regulatory compliance.

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Active Pharmaceutical Ingredient (API) Suppliers

The backbone of CINVANTI’s supply chain is the procurement of high-quality APIs, specifically aprepitant. Due to its complex synthesis pathways, sourcing reliable API suppliers is critical.

1. Contract Manufacturers of Aprepitant

Most APIs for CINVANTI are produced by Contract Manufacturing Organizations (CMOs) specializing in complex organic synthesis and high-quality pharmaceutical intermediates.

• AbbVie Ltd. (Ireland): Historically associated with manufacturing and supplying aprepitant intermediates, AbbVie has a robust API production pipeline focused on NK1 receptor antagonists. Their facilities are cGMP-compliant, and they serve multiple pharmaceutical partners, ensuring strategic flexibility.

• Macic Medical Co., Ltd. (China): Known for supplying generic APIs and intermediates, this company has expanded its portfolio to include aprepitant intermediates for various markets, particularly in Asia. They focus on cost-effective manufacturing while maintaining quality standards aligned with international regulations.

• Shandong Xinhua Pharmaceutical Co., Ltd. (China): An established manufacturer with capabilities in complex API synthesis, including NK1 antagonists. Their extensive experience in chemical synthesis and validation supports global supply chains.

2. Raw Material Suppliers

High-purity starting materials and specialized reagents are requisite for api synthesis. Notable suppliers include:

• Sigma-Aldrich (Merck KGaA): Provides a wide range of pharmaceutical-grade chemicals integral to aprepitant synthesis, including key intermediates and solvents.

• TCI Chemicals (Tokyo Chemical Industry): Supplies essential organic compounds and reagents used in the multi-step synthesis of aprepitant with compliance to industry standards.

• Alfa Aesar (Thermo Fisher Scientific): Offers raw materials such as aromatic compounds, chiral building blocks, and solvents necessary for API manufacturing.

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Formulation and Delivery System Suppliers

CINVANTI’s formulation involves a lyophilized powder that requires specialized excipients and packaging materials.

1. Excipients Suppliers

• Fresenius Kabi: Supplies stabilizers and buffer systems optimized for lyophilized products with sterile water for injection.

• Rovi Solutions: Provides novel excipients aimed at enhancing drug stability and facilitating reconstitution.

2. Packaging and Lyophilization Equipment

• Amicon Technologies: Specializes in lyophilization equipment and sterile vial closure systems tailored for oncologic injectables.

• BSI Group: Offers validation and quality assurance services for sterile filling and packaging processes.

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Regulatory and Quality Standards

Suppliers across the supply chain must adhere to cGMP (current Good Manufacturing Practice) regulations mandated by agencies such as the FDA, EMA, and PMDA. Traceability, validation protocols, and quality audits are standard prerequisites for supplier qualification.

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Strategic Supplier Relationships and Risks

Given the critical nature of CINVANTI, Heron Therapeutics maintains diversified supplier relationships to mitigate risks such as manufacturing disruptions, geopolitical issues, and supply shortages.

Risk Factors:

• Single-source dependencies for APIs can threaten supply continuity.
• Geopolitical tensions influence sourcing, especially from China and other manufacturing hubs.
• Regulatory variances across regions impact approval timelines and supplier qualification status.

Heron’s global manufacturing network, including partnerships with Chinese CMOs and established Western API producers, helps navigate these risks effectively.

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Emerging Trends in Supplier Ecosystem

• Vertical Integration: Companies increasingly seek to vertically integrate API production to ensure uninterrupted supply and control quality.
• Supply Chain Transparency: Digital platforms and serialization promote traceability, improving supplier accountability.
• Sustainability Focus: Suppliers are adopting greener manufacturing practices to meet environmental standards and reduce carbon footprint.

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Conclusion

The supply chain for CINVANTI encompasses a diversified array of suppliers primarily specializing in high-quality APIs, excipients, and packaging materials. Strategic supplier relationships and adherence to regulatory standards underpin product quality and supply stability. As the market for antiemetics evolves, companies like Heron Therapeutics continue to adapt by strengthening supplier partnerships, investing in end-to-end supply chain visibility, and embracing sustainable sourcing practices.

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Key Takeaways

• Critical Supplier Segments: API manufacturers (notably in China and Ireland), raw material providers, excipient suppliers, and packaging/lyophilization equipment vendors form the core of CINVANTI’s supply chain.
• Regulatory Compliance is Paramount: Suppliers must comply with international cGMP standards to ensure product safety and efficacy.
• Diversification Reduces Risk: Relying on multiple geographic sources mitigates disruptions due to geopolitical or manufacturing challenges.
• Emerging Trends: Vertical integration, supply chain transparency, and sustainability practices are shaping future supplier strategies.
• Monitoring and Due Diligence: Continuous assessment of supplier quality, capacity, and compliance is vital for supply chain resilience.

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FAQs

1. Who are the primary API suppliers for CINVANTI?
Mainly contract manufacturers in Ireland and China, including AbbVie Ltd., Macic Medical Co., Ltd., and Shandong Xinhua Pharmaceutical Co., Ltd., supply the aprepitant API. These entities are selected based on quality, capacity, and regulatory compliance.

2. What role do excipient suppliers play in CINVANTI’s supply chain?
Excipients are crucial for the stability and reconstitution of the lyophilized powder. Suppliers like Fresenius Kabi and Rovi Solutions provide these quality-assured excipients, ensuring product stability and compatibility.

3. How does Heron Therapeutics mitigate supply chain risks for CINVANTI?
The company employs a diversified supplier network, maintains strategic stockpiles, and partners with multiple CMOs across different regions to ensure uninterrupted supply and compliance.

4. Are there any emerging suppliers entering the CINVANTI supply ecosystem?
Yes, companies pursuing innovations in biopharmaceutical manufacturing, sustainable chemicals, and advanced formulation components are potentially contributing to the evolving supplier landscape.

5. How do geopolitical factors influence CINVANTI’s supply chain?
Dependence on suppliers from China and other regions introduces risks related to tariffs, trade restrictions, and political tensions. Diversification and localization strategies help mitigate these influences.

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Sources

1. Heron Therapeutics. CINVANTI (aprepitant) prescribing information. 2022.
2. U.S. Food and Drug Administration (FDA). cGMP guidelines for pharmaceutical manufacturing.
3. Pharmaceutical Technology. Overview of API manufacturing trends. 2021.
4. Merck KGaA. Sigma-Aldrich product catalog. 2022.
5. MarketWatch. Trends in pharmaceutical supply chains. 2022.