Suppliers and packagers for SUSTOL

SUSTOL

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	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

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Sustol

Introduction
Sustol (granisetron extended-release injection) is a prescription antiemetic used to prevent nausea and vomiting associated with chemotherapy. As an advanced formulation of granisetron, Sustol offers extended antiemetic protection, enhancing patient compliance and comfort during highly emetogenic chemotherapy regimens. Its unique extended-release mechanism necessitates specific supply chain considerations. This article examines current suppliers for Sustol, their roles in the pharmaceutical distribution ecosystem, and implications for stakeholders.

Manufacturers and Licensing Agreements

Hikma Pharmaceuticals:
Hikma Pharmaceuticals is the primary manufacturer and licensor of Sustol. The company developed the extended-release formulation of granisetron to improve upon the limitations of immediate-release versions. Hikma acquired rights to market Sustol following collaborations with the original developers, leveraging their global manufacturing infrastructure to ensure pharmaceutical quality and supply stability. Hikma's manufacturing facilities adhere to strict Good Manufacturing Practice (GMP) standards, certified by various regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Licensing and Distribution Agreements:
Hikma has established licensing agreements with regional partners to facilitate distribution across different territories. These licensing arrangements often involve local pharmaceutical firms who handle regional marketing, sales, and logistics. Such partnerships enable Sustol to reach diverse healthcare markets efficiently, while ensuring regulatory compliance within each jurisdiction.

Supply Chain Logistics and Distribution Channels

Direct Supply from Hikma:
Hikma Pharmaceuticals maintains a direct supply chain to large healthcare distributors, hospital networks, and specialty pharmacy chains. Their distribution model emphasizes maintaining the integrity of Sustol’s extended-release formulation through cold chain logistics and secure packaging. The company’s distribution centers are strategically located globally to meet demand in North America, Europe, Asia, and other regions.

Third-Party Logistics Providers:
In collaboration with third-party logistics (3PL) providers, Hikma manages last-mile delivery, ensuring safety and potency during transit. Logistics partners with experience in handling temperature-sensitive pharmaceuticals are engaged to reduce risks of degradation. These partners also support inventory management, order fulfillment, and compliance with supply regulations.

Regional Distributors and Wholesalers:
Regional intermediaries, including wholesale drug distributors and pharmacy benefit managers (PBMs), play a critical role in the Sustol supply chain. These entities purchase directly from Hikma or authorized regional licensors and sell to hospitals, clinics, and specialty pharmacies. They ensure nationwide availability, especially in markets where direct distribution may not be feasible.

Key Suppliers and Procurement Considerations

Active Pharmaceutical Ingredient (API) Sourcing:
Sustol’s efficacy depends on high-quality API production. Hikma sources granisetron API from reputable suppliers with proven GMP compliance. These API suppliers undergo rigorous validation processes, including audits and quality assurance testing, to ensure conformity to international standards. Maintaining a robust API supply chain is crucial to avoid manufacturing disruptions.

Excipients and Packaging Materials:
Material suppliers for excipients and specialized packaging are selected based on their compliance with pharmaceutical safety standards. The stability of Sustol relies on specific excipient formulations and protective packaging, which are supplied by vetted vendors specializing in pharmaceutically approved materials.

Regulatory and Patent Status

Hikma holds exclusive marketing rights for Sustol in numerous markets, with patents protecting its extended-release formulation. This exclusivity ensures minimal competition from generic equivalents for a defined period, stabilizing supply and pricing. However, as patents expire, generic formulations may enter the market, impacting the supply chain dynamics.

Market Access and Competition

While Hikma currently dominates Sustol’s supply, generic competitors may emerge once patent exclusivity ends. Entry of generics typically results in increased supply options, potentially lowering prices and expanding distribution channels. Stakeholders must monitor patent timelines and regulatory approvals to anticipate market shifts.

Implications for Stakeholders

Healthcare Providers and Pharmacists:
Reliance on Hikma or licensed regional suppliers necessitates establishing robust procurement channels to prevent shortages. Understanding regional distribution networks helps ensure consistent patient access.

Patients:
Access to Sustol depends on the efficiency and availability of its supply chain. Inventory management by distributors and pharmacies impacts treatment adherence and outcomes.

Regulatory Bodies and Policymakers:
Monitoring manufacturing quality, distribution compliance, and patent statuses ensures sustained drug availability. Regulatory authorities facilitate licensing and oversee supply chain security.

Emerging Trends and Future Outlook

• Supply Chain Digitization: Incorporating advanced tracking and inventory management systems enhances transparency for Sustol’s supply chain.
• Manufacturing Scalability: Hikma’s capacity expansions aim to meet growing global demand, especially amidst increased cancer care needs.
• Generic Competition: As patent protections lapse, supply and pricing dynamics will evolve, requiring vigilance from stakeholders.

Conclusion
Sustol’s supply chain structure is anchored by Hikma Pharmaceuticals’ manufacturing expertise and strategic distribution partnerships. The drug’s supply chain hinges on high-quality API sourcing, secure logistics, regional licensing, and regulatory compliance. Ensuring continuous availability requires coordinated efforts across manufacturers, distributors, healthcare providers, and regulators. Stakeholders must remain attentive to market dynamics, patent statuses, and emerging competitors to sustain a reliable supply of Sustol.

Key Takeaways

• Hikma Pharmaceuticals is the primary manufacturer and licensor of Sustol, with global distribution managed via regional licensing agreements.
• Supply chain integrity depends on high-quality API sourcing, secure cold chain logistics, and compliant packaging.
• Regional distributors and wholesalers serve as crucial links, ensuring widespread availability across healthcare settings.
• Patent expiration and generic entry could reshape supply and pricing; market monitoring remains essential.
• Digital tools and manufacturing scalability will influence future supply stability and accessibility.

FAQs

Q1: Who manufactures Sustol, and what is their global footprint?
A1: Hikma Pharmaceuticals manufactures Sustol, leveraging its international facilities and distribution network to supply markets across North America, Europe, and Asia.

Q2: What are the key components of Sustol’s supply chain?
A2: Sustol’s supply chain comprises API sourcing from validated suppliers, cold chain logistics, regional licensing, warehouse storage, and distribution through regional wholesalers and specialty pharmacies.

Q3: How might patent expirations affect Sustol’s supply and availability?
A3: Patent expiration could facilitate generic entry, increasing supply options, reducing costs, and potentially expanding access. Stakeholders should track patent timelines to prepare for market shifts.

Q4: What role do third-party logistics providers play in Sustol’s distribution?
A4: 3PL providers handle transportation, temperature control, warehousing, and last-mile delivery, ensuring the drug arrives intact and on time.

Q5: How can healthcare providers mitigate supply disruptions of Sustol?
A5: Establishing relationships with multiple authorized distributors, maintaining adequate inventory, and staying informed about patent and regulatory developments help mitigate risks.

References

1. Hikma Pharmaceuticals. Sustol (granisetron extended-release injection) prescribing information.
2. U.S. Food and Drug Administration (FDA). Approved drug products: Sustol.
3. European Medicines Agency (EMA). Marketing authorization for Sustol.
4. Industry reports on pharmaceutical supply chains and logistics.
5. Patent filings and expiration timelines for Sustol’s formulation.