Suppliers and packagers for sancuso

sancuso

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

Suppliers for the Pharmaceutical Drug: Sancuso

Last updated: July 30, 2025

Introduction

Sancuso is a transdermal patch formulated with granisetron, a selective 5-HT3 receptor antagonist used predominantly for the prevention of chemotherapy-induced nausea and vomiting (CINV). Its unique delivery system offers a non-invasive alternative to oral or injectable forms, enhancing patient compliance and convenience. The drug is marketed by Wintergreen LLC, with the active ingredient granisetron supplied by multiple pharmaceutical manufacturers. This report examines key suppliers involved in the manufacturing and distribution of Sancuso, evaluating their roles, market positions, and impact on the drug’s availability.

Active Pharmaceutical Ingredient (API) Suppliers for Sancuso

The cornerstone of Sancuso’s efficacy hinges on the supply of high-quality granisetron API. Several prominent manufacturers have historically supplied granisetron for commercial formulations, including Sancuso. These suppliers’ reliability, compliance with Good Manufacturing Practices (GMP), and capacity significantly influence Sancuso’s supply chain stability.

1. Dr. Reddy’s Laboratories

Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, is among global API providers for granisetron. The firm’s robust facilities in India adhere to international GMP standards, supplying APIs for various antiemetic medications, including granisetron. Dr. Reddy’s has established a significant presence in both generic and branded markets, emphasizing quality and cost competitiveness.

2. Zhejiang Yung Shin Pharmaceutical

Based in China, Zhejiang Yung Shin Pharmaceutical specializes in manufacturing cytotoxic and supportive care APIs, including granisetron. Their facilities are GMP-certified, and they operate under strict quality controls, making them a key supplier for generic formulations worldwide, including some pre-filled formulations and patches.

3. Sanofi (or other multinational API suppliers)

While Sanofi is more renowned for its proprietary formulations rather than API manufacturing for generic drugs, it has historically been involved in the API supply chain for antiemetics, either directly or through collaborations. Sanofi’s API supply chain is characterized by high quality standards and extensive distribution networks, which potentially contribute to Sancuso’s extended availability through third-party manufacturing.

Manufacturers of Sancuso (Finished Dosage Form)

Beyond API supply, the manufacturers responsible for producing the Sancuso patches play a pivotal role in ensuring product quality and timely distribution.

4. Wintergreen LLC

Wintergreen LLC holds the exclusive marketing rights for Sancuso. While not a manufacturing entity per se, they oversee the commercialization and distribution logistics, working with multiple Contract Manufacturing Organizations (CMOs).

5. Contract Manufacturing Organizations (CMOs)

Sancuso’s complex transdermal patch form involves CMOs specializing in patch technology and transdermal drug delivery systems. Key players include:

• Famar Leading Manufacturing: Known for producing transdermal patches for various pharmaceutical products, Famar provides manufacturing expertise, ensuring product consistency and regulatory compliance.
• Catalent: As a global CMO, Catalent offers transdermal patch manufacturing services, frequently collaborating with pharmaceutical companies for different formulations, including Sancuso.

These CMOs operate under strict quality standards, often under the oversight of the marketing license holder, Wintergreen LLC.

Regional Suppliers and Distribution Networks

Sancuso’s global footprint necessitates a widespread distribution network. Suppliers in North America, Europe, Asia, and emerging markets ensure the availability of both the finished product and raw materials.

• North America: Sancuso is marketed primarily in the U.S., with distribution channels managed by Wintergreen LLC through partnerships with major distributors such as McKesson and Cardinal Health.
• Europe: European supply relies on partnerships with regional distributors and potentially local CMOs for manufacturing support.
• Asia-Pacific: Given the presence of significant API suppliers in India and China, regional manufacturing and distribution centers facilitate efficient supply.

Supply Chain Considerations

The reliability of API suppliers such as Dr. Reddy’s and Zhejiang Yung Shin significantly impacts Sancuso’s availability, especially amid global supply chain disruptions. Juggling multiple API sources enhances resilience, while the presence of CMOs with specialized expertise guarantees product consistency.

Regulatory and Quality Oversight

Suppliers and manufacturers must maintain compliance with global regulatory bodies like the FDA, EMA, and others. GMP certifications, rigorous quality controls, and transparent manufacturing records are mandatory for continued supply. Disruptions due to regulatory non-compliance or quality issues can threaten the product’s availability.

Market Dynamics and Future Outlook

The demand for Sancuso remains strong due to the increasing prevalence of chemotherapy treatments worldwide. Suppliers are investing in capacity expansion, particularly in API production and transdermal technology, to meet future demand. Strategic partnerships and adherence to stringent quality standards will remain critical.

Key Suppliers Summary

Supplier	Role	Region	Notes
Dr. Reddy’s Laboratories	API manufacturing	India	Large-scale API provider, GMP-compliant
Zhejiang Yung Shin Pharmaceutical	API manufacturing	China	Key API supplier, GMP-certified
Famar Leading Manufacturing	Transdermal patch manufacturing	Greece/France	Experienced in complex dosage forms
Catalent	Transdermal technology and manufacturing	USA/Global	Industry leader in formulation support
Wintergreen LLC	Marketing and distribution	USA	Exclusive marketer of Sancuso

Conclusion

The supply chain for Sancuso hinges on a network of reliable API vendors, expert CMOs in transdermal technology, and strategic distribution channels. Ensuring quality consistency, regulatory compliance, and capacity expansion are critical priorities for maintaining continuous availability in global markets. The future viability of Sancuso will depend on these suppliers’ ability to adapt to increasing demand and evolving manufacturing standards.

---

Key Takeaways

• Multiple API suppliers, including Dr. Reddy’s and Zhejiang Yung Shin, mitigate risk and ensure supply continuity for Sancuso.
• CMOs specializing in transdermal patches are essential for manufacturing Sancuso’s complex delivery system, with Catalent and Famar leading providers.
• Regulatory compliance and quality assurance are non-negotiable, with GMP adherence critical to supplier credibility.
• Global distribution networks enable Sancuso to reach diverse markets efficiently, supported by regional partners.
• Strategic collaborations and capacity investments will be pivotal for meeting future growth in demand.

---

FAQs

1. Who are the primary API suppliers for Sancuso?
   Major API suppliers include Dr. Reddy’s Laboratories (India) and Zhejiang Yung Shin Pharmaceutical (China), both providing GMP-compliant granisetron.

2. Are there alternative suppliers for Sancuso?
   Yes, other manufacturers such as Sanofi and specialized CMOs may provide or produce components, but the primary API suppliers are those mentioned above.

3. How does supply chain disruption affect Sancuso availability?
   Disruptions in API manufacturing or CMO fabrication can lead to shortages, emphasizing the importance of diversified supplier relationships.

4. What role do CMOs play in Sancuso production?
   CMOs physicalize the complex transdermal patch manufacturing process, ensuring product quality and scalability.

5. Is Sancuso produced globally or regionally?
   While marketed globally, the manufacturing occurs through regional CMOs, with the raw API sourced from international suppliers and distribution managed worldwide.

---

Sources:
[1] Pharmaceutical APIs Market, Frost & Sullivan Reports.
[2] GMP-certified API manufacturers’ websites and certifications.
[3] Wintergreen LLC Official Website.
[4] Industry analysis reports on transdermal drug delivery systems.