Suppliers and packagers for generic pharmaceutical drug: granisetron

granisetron

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198	NDA	Cumberland Pharmaceuticals Inc.	66220-637-31	168 h in 1 POUCH (66220-637-31)	2024-07-16
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198	NDA	Cumberland Pharmaceuticals Inc.	66220-637-72	168 h in 1 POUCH (66220-637-72)	2024-07-16
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445	NDA	Heron Therapeutics, Inc.	47426-101-06	6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS	2016-08-09

Suppliers for the Pharmaceutical Drug: Granisetron

Last updated: July 29, 2025

Introduction

Granisetron is a potent 5-HT3 receptor antagonist used primarily for the prevention of chemotherapy-induced nausea and vomiting (CINV). Its efficacy and safety profile have made it a key drug within oncological supportive care. The global pharmaceutical supply chain for granisetron encompasses various manufacturers, suppliers, and distributors, each operating within different regulatory and commercial frameworks. This article provides a comprehensive overview of the principal suppliers for granisetron, emphasizing their manufacturing capacity, market presence, regulatory status, and strategic significance.

Manufacturers and Contract Pharma Producers

1. F. Hoffmann-La Roche Ltd.

Overview:
Roche is a pioneering entity in the development and commercialization of granisetron, with its branded product, Kytril. As one of the earliest and most significant suppliers, Roche's global distribution network ensures widespread availability across healthcare markets.

Manufacturing Capabilities:
Roche's manufacturing facilities are compliant with Good Manufacturing Practices (GMP) across multiple regulatory jurisdictions, including the US FDA and EMA. The company produces granisetron both as a finished formulation and as an active pharmaceutical ingredient (API).

Market Presence:
Kytril remains a benchmark brand, often used as a reference drug in regulatory and clinical settings. Roche’s extensive global reach consolidates its role as a key supplier, particularly in North America and Europe.

2. Teva Pharmaceutical Industries Ltd.

Overview:
Teva is a leading generic pharmaceutical company worldwide, with a significant portfolio of antiemetic drugs, including granisetron. Their generic formulations compete extensively with branded products.

Manufacturing Capabilities:
Teva operates multiple manufacturing sites complying with GMP standards, with an emphasis on cost-effective production to offer affordable generic options globally.

Market Presence:
Teva’s granisetron products are licensed and marketed in numerous jurisdictions, especially in emerging markets and regions where cost-sensitive healthcare benefits are prioritized.

3. Mylan N.V. (now part of Viatris)

Overview:
Mylan, now integrated into Viatris, has historically supplied generic granisetron formulations, serving hospitals and specialty clinics.

Manufacturing Capabilities:
Viatris maintains manufacturing facilities producing APIs and finished dosage forms, with a focus on quality assurance aligned with global regulatory standards.

Market Presence:
Viatris' global footprint ensures widespread distribution, particularly in areas with high demand for affordable antiemetic options.

4. Astellas Pharma Inc.

Overview:
While primarily known for other therapeutic areas, Astellas has been involved in the development of related antiemetic agents and may supply granisetron in certain markets through licensing agreements or partnerships.

Manufacturing Capabilities:
Astellas’ manufacturing facilities are GMP-compliant, ensuring high purity and quality for their pharmaceutical products.

Market Presence:
Their role is more niche but significant in Japan and parts of Asia.

5. Other Regional and Contract Manufacturers

Numerous smaller or regional manufacturers produce granisetron as APIs or finished formulations, responding to local market needs and regulatory demands. These companies often operate under licensing agreements with larger firms or serve as contract manufacturing organizations (CMOs).

Regulatory and Supply Chain Considerations

• Regulatory Approvals:
  Most suppliers must adhere to stringent regulatory standards such as those set by the FDA (US), EMA (European Union), and other national agencies. Approval status influences market access and manufacturing quality.

• Supply Chain Dynamics:
  The global supply chain for granisetron involves sourcing of raw materials, multi-tiered manufacturing processes, and distribution channels spanning hospitals, clinics, and wholesalers. Disruptions—due to geopolitical issues, raw material shortages, or pandemic-related constraints—can impact availability.

• Patent and Exclusivity Status:
  Originally patented by Roche, generic manufacturers gained market access following patent expiry. Patent expiry varies by country, influencing market entry and pricing strategies.

Emerging Markets and Regional Suppliers

In regions such as Asia, Latin America, and Africa, local generics producers are increasingly entering the granisetron market. Companies like Synthesis, Hetero Drugs, and Zhongmei Pharmaceutical manufacture APIs and formulations catering to local needs, often under licensing or partnership agreements with global firms.

Strategic Implications for Stakeholders

• Healthcare Providers:
  Choosing suppliers depends on considerations of cost, regulatory approval, supply reliability, and product quality. Certified generics from reputable suppliers like Teva, Viatris, and Roche are preferred.

• Pharmaceutical Companies:
  Market entrants must navigate complex patent landscapes, regulatory approvals, and distribution networks. Partnerships with regional manufacturers can enhance market penetration, especially in emerging markets.

• Investors and Distributors:
  A stable supply chain, backed by GMP-compliant facilities and regulatory approvals, is critical for minimizing risks associated with shortages or quality issues.

Conclusion

The supply landscape for granisetron is characterized by a mix of pioneering firms, such as Roche, and prominent generic manufacturers including Teva, Viatris, and regional producers. Their combined efforts ensure broad access to this vital antiemetic, crucial for cancer supportive care. Given the importance of regulatory compliance, manufacturing quality, and supply chain stability, stakeholders must scrutinize supplier credentials and track record to ensure consistent drug availability.

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Key Takeaways

• Major global suppliers of granisetron include Roche, Teva, Viatris, and select regional manufacturers, each contributing significantly to the drug’s availability.

• Regulatory compliance and GMP-certified manufacturing are critical criteria for supplier evaluation, impacting quality and market access.

• Emerging markets feature increasing local production, driven by patent expiries and cost considerations, expanding supply chain diversity.

• Supply chain resilience is essential, especially amid geopolitical and health crises, requiring diversification of suppliers and robust distribution networks.

• Strategic partnerships between global pharmaceutical firms and regional manufacturers optimize market penetration and ensure continuous drug supply.

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FAQs

1. Who are the leading global suppliers of granisetron?
The primary suppliers include Roche (brand Kytril), Teva, and Viatris, all of which produce both branded and generic formulations, with widespread international distribution.

2. Are generic manufacturers reliable sources for granisetron?
Yes. Reputable generics producers like Teva and Viatris adhere to international GMP standards, ensuring quality and regulatory compliance, making them reliable sources.

3. How does patent status influence the supply of granisetron?
Patent expiration allows generic manufacturers to produce and market their versions, increasing supply diversity and reducing prices. Patent cliffs often lead to increased regional manufacturing options.

4. What are the risks associated with the granisetron supply chain?
Risks include manufacturing disruptions, regulatory delays, raw material shortages, and geopolitical factors, potentially causing shortages or quality issues.

5. How can healthcare providers ensure consistent supply of granisetron?
By establishing relationships with certified suppliers, diversifying sources, monitoring regulatory updates, and engaging with distributors who maintain inventories and supply chain resilience.

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References:

[1] U.S. FDA Drug Approvals and Registrations.
[2] European Medicines Agency (EMA) Product Information.
[3] Roche, Teva, and Viatris official websites and corporate reports.
[4] Industry analyses from IQVIA and EvaluatePharma.
[5] WHO Model List of Essential Medicines, 20th Edition.