Share This Page
Suppliers and packagers for VYLEESI (AUTOINJECTOR)
✉ Email this page to a colleague
VYLEESI (AUTOINJECTOR)
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cosette | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0897-04 | 4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06) | 2025-11-12 |
| Cosette | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557 | NDA | Palatin Technologies | 80064-141-02 | 2 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01) | 2019-06-21 |
| Cosette | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557 | NDA | Palatin Technologies | 80064-141-04 | 4 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01) | 2019-06-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VYLEESI (Autoinjector)
Introduction
VYLEESI, an autoinjector developed for advanced drug delivery, represents a significant innovation within the pharmaceutical device landscape. Autoinjectors are designed to enable patients to administer medications safely and conveniently, often for chronic conditions requiring self-injection. As a specialized device, the supply chain for VYLEESI encompasses a range of vendors providing components, manufacturing services, and assembled systems capable of meeting stringent regulatory standards. This report delineates the key suppliers involved in various stages of VYLEESI's supply chain, offering insights critical for stakeholders analyzing procurement, manufacturing, or competitive positioning.
1. Components and Raw Material Suppliers
a. Spring Mechanisms and Actuator Components
Autoinjectors rely on precision-engineered springs and actuators to facilitate accurate medication delivery.
- Reliant Spring Co., Ltd. – A leading provider of high-performance, medical-grade springs, offering custom designs resilient to sterilization processes and ensuring consistent dosing.
- James Walker Group – Supplies elastomeric and plastic components, including trigger mechanisms and seals required for autoinjector operation.
b. Cartridges and Medication Containers
The integrity of the medication container is vital for stability and bioavailability.
- Gerresheimer AG – A prominent manufacturer of glass and plastic cartridges, vials, and systems optimized for pre-filled drug delivery devices.
- Schott AG – Supplies borosilicate glass cartridges with advanced coating technology to prevent drug adhesion and maintain sterility.
c. Actuator and Shell Materials
The shell material must be durable, biocompatible, and suitable for precision molding.
- BASF SE – Provides high-grade thermoplastics such as polycarbonate and ABS, widely utilized in device shells for their impact resistance and sterilization compatibility.
- Evonik Industries – Offers specialty polymers with properties tailored for medical device enclosures, emphasizing chemical resistance and long-term stability.
2. Manufacturing Service Providers
a. Device Assembly and Injection Molding
Manufacturers specialized in medical device assembly are critical for ensuring quality and compliance.
- Ypsomed – A Swiss-based company recognized for design, manufacturing, and assembly of autoinjectors, including VYLEESI, leveraging extensive experience in complex device assembly under GMP standards.
- Nemera – Offers comprehensive services including injection molding, device assembly, and packaging, with a focus on high-volume production of injectable devices.
b. Sterilization and Packaging
Steriling services are essential to meet regulatory standards and ensure patient safety.
- STERIS Corporation – Provides sterilization services (ETO, gamma) tailored for medical devices like autoinjectors, ensuring sterility without degrading device components.
- WestRock – Supplies customized packaging solutions designed to preserve device integrity during shipping and storage.
3. Regulatory and Quality Certification
Manufacturers and suppliers must adhere to strict compliance standards such as ISO 13485, FDA regulations, and GMP.
- Certifications Held: Many suppliers hold certifications such as ISO 13485, ISO 9001, and Good Manufacturing Practice (GMP), indicating adherence to quality management systems essential for medical devices.
4. Critical Supplier Attributes
Given the specialized nature of VYLEESI:
- Regulatory Compliance: Suppliers must operate under rigorous quality standards, with documented validation processes.
- Material Quality: Use of biocompatible, durable materials capable of withstanding sterilization and repeated use.
- Supply Chain Reliability: Consistent delivery schedules, risk mitigation strategies, and capacity for volume scaling are mandatory.
- Innovation Capability: Suppliers should possess R&D capabilities to develop or customize components aligning with technological advances and user feedback.
5. Collaborations with Original Equipment Manufacturers (OEMs)
VYLEESI's successful deployment involves partnerships with OEMs specializing in:
- Design for manufacturability
- Human factors engineering to enhance user experience
- Regulatory submission support to streamline approval processes
These relationships often involve tight integration between pharmaceutical companies and device manufacturers.
Key Suppliers Summary
| Category | Leading Suppliers | Core Capabilities | Notes |
|---|---|---|---|
| Springs & Actuators | Reliant Spring Co., Ltd.; James Walker Group | Medical-grade springs; elastomers | Critical for precise dose delivery |
| Cartridges & Containers | Gerresheimer AG; Schott AG | Glass/plastic prefilled containers | Stability and compatibility with drug formulations |
| Device Materials | BASF SE; Evonik Industries | Thermoplastics; polymers | Device shell durability and biocompatibility |
| Manufacturing & Assembly | Ypsomed; Nemera | Assembly, molding, packaging | High-volume, compliant production |
| Sterilization & Packaging | STERIS Corporation; WestRock | Sterilization services; packaging | Maintains sterility and device integrity |
Conclusion
The supply landscape for VYLEESI autoinjector integrates specialized component manufacturers, advanced materials suppliers, and high-capacity OEM assembly services. Ensuring reliable sourcing demands rigorous supplier qualification, consistent quality performance, and compliance with stringent medical standards. Strategic partnerships, continuous innovation, and supply chain resilience form the backbone of successful VYLEESI deployment, positioning it for regulatory approval and market penetration.
Key Takeaways
- Supply chain integrity is paramount; prioritize suppliers with proven GMP/ISO certifications and extensive medical device experience.
- Component quality directly impacts device performance; selecting suppliers offering biocompatible, sterilization-compatible materials ensures compliance and safety.
- Manufacturing partnerships should emphasize scalable, compliant assembly processes capable of supporting both initial launches and ongoing production demands.
- Innovating supplier collaborations can enhance device features and user experience, providing a competitive advantage within the self-injection market.
- Proactive risk management in supplier relationships mitigates potential disruptions, ensuring uninterrupted supply and regulatory compliance.
FAQs
1. Who are the main component suppliers for VYLEESI's autoinjector?
Major component suppliers include Reliant Spring Co., Ltd. for springs, Gerresheimer AG and Schott AG for cartridges, and BASF SE and Evonik Industries for device shell materials.
2. What qualities should a supplier have to effectively support VYLEESI's manufacturing needs?
Suppliers should possess ISO 13485 or equivalent certification, demonstrate consistent quality, have experience with sterilizable medical components, and be capable of high-volume production with reliable delivery.
3. Are there regional supplier concentrations for VYLEESI manufacturing?
Yes; Europe hosts many key suppliers given stringent EU standards, but global suppliers from North America and Asia also serve the medical device industry, providing cost and supply chain diversification.
4. How critical is regulatory compliance in selecting suppliers for VYLEESI?
Extremely critical; suppliers must comply with medical device standards to ensure safety, efficacy, and regulatory approval processes are not hindered.
5. Can new suppliers be integrated mid-project for VYLEESI?
Yes, but this requires rigorous qualification, validation, and regulatory validation to meet the existing design and quality specifications, potentially extending timelines.
References
[1] Market research reports on autoinjector supply chains and component manufacturers.
[2] Company websites and product datasheets from Reliant Spring Co., Ltd., Gerresheimer AG, Schott AG, BASF SE, Evonik Industries.
[3] Regulatory guidelines from ISO and FDA relevant to medical device suppliers.
More… ↓
