Suppliers and packagers for secuado

secuado

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268	NDA	Noven Therapeutics, LLC	68968-0172-3	30 POUCH in 1 CARTON (68968-0172-3) / 1 d in 1 POUCH	2020-02-12
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268	NDA	Noven Therapeutics, LLC	68968-0172-7	7 POUCH in 1 CARTON (68968-0172-7) / 1 d in 1 POUCH	2020-02-12
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268	NDA	Noven Therapeutics, LLC	68968-0173-3	30 POUCH in 1 CARTON (68968-0173-3) / 1 d in 1 POUCH	2020-02-12
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268	NDA	Noven Therapeutics, LLC	68968-0173-7	7 POUCH in 1 CARTON (68968-0173-7) / 1 d in 1 POUCH	2020-02-12

Suppliers for the Pharmaceutical Drug: Secuado

Last updated: August 6, 2025

Introduction

Secuado (risperidone) transdermal system is a medication designed to deliver antipsychotic treatment through controlled transdermal absorption. Approved by regulatory agencies such as the FDA, Secuado offers a novel administration route primarily used for schizophrenia and bipolar disorder. Its unique transdermal formulation benefits patients by providing a steady release, reducing peak-trough fluctuations associated with oral medications, and improving compliance. As the pharmaceutical industry continues to innovate around transdermal drug delivery, understanding Secuado’s supply chain dynamics and key suppliers is essential for stakeholders involved in manufacturing, distribution, and investment decisions.

Manufacturers of Secuado

Janssen Pharmaceuticals (a Johnson & Johnson company)

Janssen is the proprietary manufacturer of Secuado. The company developed the product to fulfill a clinical and commercial need for a transdermal risperidone system. As the originator, Janssen is responsible for formulation development, regulatory approvals, manufacturing, and distribution within regulated markets.

Manufacturing Facilities

Janssen’s manufacturing operations for Secuado are confined to facilities dedicated to transdermal and controlled-release formulations, primarily based in the United States and Europe. These facilities meet Good Manufacturing Practice (GMP) standards set by authorities such as the FDA and EMA, ensuring product consistency and quality.

Supply Chain and Distribution Partners

While Janssen retains control over the production of the Secuado transdermal patches, its distribution network involves several logistics partners to ensure global availability:

• Logistics Providers: DHL, FedEx, and UPS handle domestic and international transportation, ensuring timely delivery across markets.
• Third-Party Logistics (3PL) Providers: These partners manage warehousing, inventory, and order fulfillment, minimizing delays and optimizing supply chain efficiency.
• Regulatory and Local Distributors: Local pharmaceutical distributors and pharmacies partner with Janssen to facilitate patient access, especially in regions like North America, Europe, and Asia-Pacific.

Key Suppliers for Secuado Components

Secuado’s transdermal patches consist of proprietary multilayer films combining adhesives, drug reservoirs, backing layers, and release liners. The supply of these components involves specialized suppliers:

1. Active Pharmaceutical Ingredient (API): Risperidone

• Primary API Suppliers: Global bulk risperidone manufacturing is dominated by a handful of suppliers, including Zhejiang Jiuzhou Pharmaceutical Co., Teva Pharmaceutical Industries, and Hikma Pharmaceuticals.
• Quality and Compliance: Suppliers must adhere to GMP standards, with rigorous testing and validation to meet Janssen’s specifications.
• Supply Risks: API shortages or quality issues can impact Secuado’s production, making supplier diversification critical.

2. Adhesives and Polymer Films

• Specialized Material Suppliers: Leading companies like 3M, BASF, and Henkel manufacture medical-grade adhesives and polymer films used in transdermal patches.
• Technological Compatibility: Suppliers need to meet stringent biocompatibility standards while providing formulations compatible with risperidone and skin adhesion properties.

3. Backing Layers and Release Liners

• Suppliers of medical-grade backing films include DuPont and Saint-Gobain.
• Release liners often originate from specialized coating companies such as Berry Global and Rogers Corporation.

Emerging and Alternative Suppliers

In response to potential supply chain disruptions, Janssen actively monitors and qualifies alternative suppliers for critical components. The trend toward vertical integration and strategic procurement practices enhances supply resilience. Additionally, some regional manufacturers are being vetted to facilitate local production and distribution, especially amid global supply chain challenges highlighted during the COVID-19 pandemic.

Regulatory Considerations and Supplier Qualification

Suppliers for Secuado must navigate a complex regulatory landscape, requiring:

• Certification of GMP compliance
• Validation of raw materials and component consistency
• Periodic auditing by Janssen and regulatory agencies
• Supply continuity plans to mitigate shortages

Manufacturers and suppliers are expected to maintain high standards to ensure patient safety and product efficacy, complicating the supplier landscape and emphasizing supply chain security.

Market Outlook and Supplier Opportunities

With increasing demand for novel drug delivery systems, many suppliers see opportunities in the transdermal drug market, including:

• Development of high-quality adhesives
• Innovative polymer films with enhanced permeation qualities
• Advanced manufacturing processes that improve scalability and reduce costs

Furthermore, patent expirations or generics entrants could alter supply chain dynamics; however, currently, Secuado primarily remains under Janssen’s control due to proprietary technology.

Conclusion

Secuado’s supply chain is characterized by a tightly controlled manufacturing process led by Janssen Pharmaceuticals, relying on a network of global suppliers for active ingredients, adhesives, films, and other components. Ensuring a stable, high-quality supply chain depends on diversified procurement, rigorous supplier qualification, and adherence to regulatory standards. As the market for transdermal medications grows, new supplier opportunities emerge, promising enhanced resilience and competitive advantages.

---

Key Takeaways

• Janssen Pharmaceuticals is the sole manufacturer of Secuado, controlling production and distribution.
• Key component suppliers include risperidone bulk manufacturers and specialized adhesive and film providers.
• Supply chain resilience hinges on diversified sourcing, regulatory compliance, and robust quality management.
• Emerging suppliers in adhesives and polymer films present growth opportunities amidst increasing demand.
• Strategic supplier qualification and risk mitigation are vital to maintaining consistent Secuado availability.

---

Frequently Asked Questions (FAQs)

1. Who are the main suppliers for the risperidone active pharmaceutical ingredient (API) used in Secuado?
Major risperidone API suppliers include Zhejiang Jiuzhou Pharmaceutical, Teva Pharmaceutical Industries, and Hikma Pharmaceuticals, all compliant with GMP standards.

2. Are there alternative suppliers for transdermal materials used in Secuado?
Yes, companies like 3M, BASF, Henkel, DuPont, and Saint-Gobain supply the specialized adhesives and films. Janssen evaluates multiple sources to ensure supply continuity.

3. How does Janssen ensure quality across its supply chain?
Janssen mandates GMP certifications, conducts regular audits, and requires strict validation of raw materials and component suppliers.

4. What are the risks associated with Secuado’s supply chain?
Risks include API shortages, disruptions in high-quality adhesive supply, manufacturing delays, and regulatory hurdles—all mitigated through strategic sourcing and supplier diversification.

5. How is the supply chain for Secuado expected to evolve?
The trend toward regional manufacturing, supplier diversification, and technological innovation in transdermal delivery enhances supply resilience; new suppliers are increasingly competing in this niche.

---

References

1. U.S. Food and Drug Administration. Secuado (risperidone) transdermal system approval documentation.
2. Janssen Pharmaceuticals. Secuado Product Information.
3. Industry reports on transdermal drug delivery suppliers.
4. GMP standards and guidelines from the FDA and EMA.