Suppliers and packagers for generic pharmaceutical drug: FOSAPREPITANT DIMEGLUMINE

FOSAPREPITANT DIMEGLUMINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023	NDA	Merck Sharp & Dohme LLC	0006-3061-00	1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-00) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01)	2017-02-03
Aspiro	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	214616	ANDA	NorthStar RxLLC	16714-248-01	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-248-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2023-01-28
Aspiro	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	214616	ANDA	Camber Pharmaceuticals, Inc.	31722-165-31	1 VIAL, SINGLE-DOSE in 1 CARTON (31722-165-31) / 5 mL in 1 VIAL, SINGLE-DOSE	2021-07-29

Suppliers for the Pharmaceutical Drug: Fosaprepitant Dimeglumine

Last updated: July 29, 2025

Introduction

Fosaprepitant dimeglumine is a prodrug of aprepitant, used primarily as an antiemetic in chemotherapy-induced nausea and vomiting (CINV). It is a key component in supportive cancer care, classified as an NK1 receptor antagonist. The global demand for fosaprepitant dimeglumine has surged, driven by the expanding oncology patient population and evolving standards for supportive care, making its supply chain critically important for pharmaceutical companies, healthcare providers, and wholesalers.

This analysis provides a comprehensive overview of key suppliers manufacturing and distributing fosaprepitant dimeglumine, outlining their capabilities, regulatory standing, and market positioning. Understanding these suppliers offers critical insights for stakeholders involved in procurement, manufacturing, and distribution within the pharmaceutical supply chain.

Manufacturers of Fosaprepitant Dimeglumine

1. MSD (Merck & Co.)

Market Presence and Production Capacity
Merck, the originator of fosaprepitant dimeglumine, markets it under the brand name Emend for Injection. As part of its global operations, Merck maintains an extensive manufacturing network capable of large-scale production to meet worldwide demand. The company’s manufacturing facilities, located in the United States and Europe, adhere to strict Good Manufacturing Practices (GMP), ensuring high-quality standards necessary for injectable drugs.

Regulatory Certification and Distribution
Merck’s Fosaprepitant Dimeglumine is approved in multiple markets, including the US, Europe, and Asia, under regulatory agencies such as the FDA and EMA. Its approval status and robust supply channels make Merck a primary and reliable supplier, especially for hospital settings and oncology clinics globally.

Supply Chain and Distribution
Merck leverages a comprehensive distribution network, including direct supplies to major hospitals, pharmacies, and wholesalers. Its strategic partnerships and global manufacturing footprint secure a steady supply amid fluctuating market demands.

2. Teva Pharmaceuticals

Role as a Major Producing Partner
Though initially developed by Merck, Teva Pharmaceuticals has entered licensing agreements for the manufacture and distribution of fosaprepitant dimeglumine in various markets, particularly in emerging economies. Teva’s extensive global manufacturing infrastructure allows it to produce pharmaceutical-grade fosaprepitant at scale.

Manufacturing Capabilities and Quality Assurance
Teva’s manufacturing facilities are GMP-compliant, with global certifications that meet international standards, enabling them to supply to North America, Europe, Latin America, and parts of Asia. This flexibility increases availability, especially in regions with high CINV treatment needs.

Market Focus and Distribution
Teva emphasizes expanding access through strategic partnerships and local manufacturing. Its capacity complements Merck’s supply, particularly in regions where local regulatory approvals facilitate faster distribution.

3. Sun Pharmaceutical Industries

Emerging Market Supplier
As one of India’s largest pharmaceutical companies, Sun Pharma has developed capabilities to manufacture fosaprepitant dimeglumine, primarily targeting the Indian subcontinent and surrounding emerging markets.

Manufacturing and Regulatory Standing
Sun Pharma’s GMP-compliant facilities and local regulatory approvals position it as a key supplier for regional healthcare providers. However, their global distribution footprint is more limited compared to Merck and Teva.

Strategic Importance
Sun Pharma’s role has grown amid increased demand in Asia. Although its supply is primarily regional, it remains a significant player in providing affordable antiemetic agents.

Additional Suppliers and Contract Manufacturers

4. Contract Manufacturing Organizations (CMOs)

Several CMOs specialize in the production of fosaprepitant dimeglumine for major pharmaceutical firms. These include companies like Fresenius Kabi and Sandoz, which provide contract manufacturing to ensure bulk supply, often catering to markets with high demand or regional regulatory approvals.

Their capacities differ based on client agreements but generally emphasize high standards of quality assurance and compliance with international GMP guidelines.

5. Local and Regional Pharmaceutical Companies

In markets such as China, South Korea, and Brazil, various local pharmaceutical manufacturers possess the technical capability to produce fosaprepitant dimeglumine, often under licensing agreements or generic pathways. These players primarily serve domestic needs but may expand into neighboring regions under strategic partnerships.

Regulatory Landscape and Impact on Suppliers

The approval of fosaprepitant dimeglumine by authorities like the FDA, EMA, and PMDA has historically favored the original developer, Merck. However, generic manufacturers and CMOs are increasingly entering markets following patent expirations or licensing agreements.

Regional regulatory environments significantly influence supplier dynamics. For instance, in countries with expedited approval pathways or local manufacturing incentives, regional suppliers can quickly gain market share, impacting global supply chains.

Market Dynamics and Supply Risks

While Merck remains the primary supplier globally, reliance on a limited number of manufacturers introduces supply risks—particularly in the face of manufacturing disruptions, regulatory delays, or geopolitical issues. The active participation of regional players and CMOs reduces such risks but requires rigorous quality assurance.

Emerging trends suggest a move towards diversified supplier portfolios, strategic stockpiling, and regional manufacturing alliances to mitigate supply chain vulnerabilities.

Conclusion

The supply of fosaprepitant dimeglumine hinges on a handful of large pharmaceutical companies and a network of contract and regional manufacturers. Merck’s dominant position as the originator and primary supplier ensures high-quality and consistent supply in mature markets, while Teva, Sun Pharma, and regional players expand access across diverse geographies.

Sustained demand, regulatory approvals, and manufacturing capacity planning are crucial for maintaining an uninterrupted supply chain. Stakeholders must monitor geopolitical shifts, patent statuses, and regional manufacturing developments to anticipate supply chain adjustments proactively.

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Key Takeaways

• Merck remains the primary global supplier, with extensive manufacturing and distribution networks.
• Teva and Sun Pharma are significant regional players, expanding access in emerging and localized markets.
• Contract Manufacturing Organizations (CMOs) play crucial roles in scaling production and ensuring supply chain resilience.
• Diversified supplier bases and regional manufacturing alliances are essential to mitigate supply risks amid increasing global demand.
• Regulatory approvals and regional policies influence supplier dynamics, affecting availability and pricing.

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FAQs

1. Who are the leading manufacturers of fosaprepitant dimeglumine globally?
Merck is the original developer and primary supplier internationally, with Teva Pharmaceuticals and Sun Pharma playing major roles in regional markets.

2. Can generic producers supply fosaprepitant dimeglumine?
Yes, after patent expirations, several generic manufacturers and CMOs can produce and supply fosaprepitant dimeglumine, especially in emerging markets.

3. Are there potential supply chain disruptions for fosaprepitant dimeglumine?
Supply disruptions can occur due to manufacturing issues, regulatory delays, or geopolitical factors affecting primary and regional suppliers.

4. What regulations impact the manufacturing and supply of fosaprepitant dimeglumine?
Regulatory approvals from agencies like the FDA, EMA, and PMDA govern manufacturing standards and market access, influencing supplier capabilities.

5. How is regional manufacturing influencing the availability of fosaprepitant dimeglumine?
Regional manufacturing enhances access, reduces costs, and decreases dependency on a limited number of global suppliers, contributing to supply stability.

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References

[1] Merck & Co., Inc. "Fosaprepitant Dimeglumine (Emend for Injection)." FDA Database, 2022.
[2] Teva Pharmaceuticals Annual Report, 2022.
[3] Sun Pharmaceutical Industries Ltd. Product Portfolio, 2022.
[4] World Health Organization (WHO). "Guidelines for antiemetic drug production," 2021.
[5] Industry reports on antiemetic drug market and supply chain analysis, 2022.