WAINUA (AUTOINJECTOR): Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388	NDA	AstraZeneca Pharmaceuticals LP	0310-9400-01	45 mg in 1 SYRINGE, GLASS (0310-9400-01)	2023-12-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction
WAINUA is an innovative pharmaceutical product supplied via autoinjector technology, designed to enable self-administration of specific medications. The drug's success depends significantly on a reliable supply chain, encompassing raw material providers, device manufacturing firms, and logistics partners. Identifying key suppliers of WAINUA’s autoinjector components, formulation ingredients, and packaging materials is essential for pharmaceutical companies, investors, and healthcare providers aiming to ensure uninterrupted product availability and compliance with regulatory standards.

Overview of WAINUA (Autoinjector) and its Supply Chain Components

WAINUA's autoinjector package integrates complex components: the pre-filled pharmaceutical syringe, device hardware, device mechanics, and accompanying packaging. Critical to its manufacturing and distribution are:

Active pharmaceutical ingredients (APIs)
Autoinjector device components (plungers, cartridges, springs, etc.)
Device plastics and electronic or mechanical parts
Packaging materials

The supply chain's robustness relies on global and regional manufacturers that meet stringent quality standards such as Good Manufacturing Practices (GMP), ISO certifications, and regulatory compliance with agencies like the FDA and EMA.

Key Suppliers in the WAINUA Autoinjector Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

While the precise API for WAINUA depends on its therapeutic indication, common high-quality chemical suppliers include:

Catalent Pharma Solutions
A leading global API and formulation contractor, known for supplying high purity APIs with comprehensive quality assurance systems. Catalent supports various therapeutics requiring specialized APIs, aligning with WAINUA’s quality standards ([1]).
Thermo Fisher Scientific
Offers a broad portfolio of APIs for injectable drugs, with facilities adhering to strict GMP standards, ensuring high purity and consistent batch quality.
BASF
Supplies pharmaceutical-grade chemical intermediates and APIs, with global manufacturing sites adhering to international quality standards.
Lonza
A contract development and manufacturing organization that provides APIs and intermediates, especially for niche and complex molecules.

2. Autoinjector Device Components Suppliers

Skilled manufacturing of autoinjector devices involves suppliers specializing in precision-engineered plastics, springs, and electronic components:

Ypsomed AG
A leading manufacturer of injection devices, Ypsomed supplies customized autoinjector platforms that can be integrated into WAINUA formulations. Their products are compliant with international safety and quality standards ([2]).
BD (Becton, Dickinson and Company)
A global leader in syringe and injection device manufacturing. BD supplies pre-filled syringes and autoinjector systems widely used in the pharmaceutical industry, known for high reliability and regulatory compliance.
Gerresheimer AG
Specializes in glass and plastic pharmaceutical packaging, including cartridges, syringes, and safety devices for autoinjectors.
Nordson MEDICAL
Provides precision assembly and component manufacturing for medical devices, including springs, plungers, and interaction mechanisms in autoinjectors.

3. Plastic and Electronic Component Suppliers

Röchling Group
Supplies medical-grade plastics used in autoinjector casings and internal components, ensuring biocompatibility and durability.
TE Connectivity
Supplies micro-electronic components, sensors, and connectors for electronic autoinjectors, if applicable, maintaining compliance with medical device regulations.
Ensinger
Provides high-performance engineering plastics suitable for medical device applications, ensuring stability and biocompatibility.

4. Packaging and Labeling Suppliers

Proper packaging preserves drug integrity and facilitates user safety:

West Pharmaceutical Services
Supplies elastomeric closures, stoppers, and safety caps for pre-filled syringes and autoinjectors, ensuring optimal sealing and ease of use.
Schott AG
Manufactures pharmaceutical glass vials and cartridges compatible with autoinjector systems.
Amcor and Albéa
Offer primary packaging films, labels, and secondary packaging solutions that comply with pharmaceutical regulations.

Supply Chain Considerations and Challenges

The supply chain for WAINUA involves multiple tiers, each subject to regional regulatory differences, geopolitical disruptions, and raw material shortages. Ensuring supplier qualification compliance, maintaining traceability, and securing contingency plans are vital. Recent global supply chain disruptions, notably during the COVID-19 pandemic, highlighted vulnerabilities within both material procurement and device manufacturing domains.

Furthermore, the increasing demand for high-quality autoinjectors necessitates strategic partnerships with major OEM suppliers capable of scaling production while adhering to strict quality standards. Vertical integration or strategic alliances with key suppliers can optimize lead times, cost efficiency, and quality control.

Emerging Suppliers and Innovation Trends

The industry is witnessing disruptive innovations with smart autoinjectors integrated with electronic health management features. Suppliers focusing on digital health integration—such as Ypsomed and BD—are expanding their capabilities:

Ypsomed's "mylife™" connected autoinjectors enhance patient adherence and real-time monitoring.
BD is pioneering IoT-enabled injection devices with integrated sensors, requiring suppliers of sensitive electronic components.

Emerging suppliers and startups are also investing in biodegradable device components and sustainable packaging solutions, driven by environmental policies and cost considerations ([3]).

Regulatory and Quality Assurance in Supplier Selection

Partnering with suppliers that satisfy regulatory standards is non-negotiable. Suppliers must demonstrate compliance with:

GMP Certification
ISO 13485 for Medical Devices
FDA and EMA approvals for specific components
Product traceability and validation records

The qualification process encompasses audits, batch testing, stability assessments, and ongoing quality monitoring.

Conclusion

The supply chain for WAINUA's autoinjector involves a complex ecosystem of global providers specializing in pharmaceutical ingredients, precision device components, electronic systems, and packaging. Leading suppliers such as Catalent, Ypsomed, BD, and West Pharmaceutical Services dominate key aspects. Ensuring collaboration with qualified, compliant suppliers is essential for uninterrupted supply, regulatory adherence, and continued innovation in autoinjector technology.

Key Takeaways

Diverse Supplier Ecosystem: WAINUA’s supply chain spans globally recognized API providers, device manufacturers, component suppliers, and packaging firms.
Regulatory Compliance Critical: Suppliers must meet GMP, ISO, and other regulatory standards to ensure product safety and quality.
Strategic Partnerships: Long-term collaborations with key suppliers like Ypsomed and BD optimize manufacturing scalability and quality.
Innovation Adoption: Suppliers of smart device components and sustainable materials are gaining prominence, aligning with industry trends.
Risk Management Essential: Supply chain resilience requires contingency planning and rigorous supplier qualification processes.

FAQs

1. Who are the leading suppliers for autoinjector devices similar to WAINUA?

Answer: Major players include Ypsomed AG, BD (Becton, Dickinson & Company), and Gerresheimer AG, known for their high-quality, compliant autoinjector platforms and device components.

2. What are the key qualities to look for in an API supplier for WAINUA?

Answer: High purity standards, GMP compliance, proven batch-to-batch consistency, and regulatory approvals are essential qualities.

3. How does supplier qualification impact WAINUA's regulatory approval?

Answer: Supplier qualification ensures all components meet regulatory standards, minimizes approval risks, and supports compliance with agencies like the FDA and EMA.

4. Are there any emerging trends in autoinjector suppliers?

Answer: Yes, increasing integration of digital health features, eco-friendly materials, and smart device electronics are emerging trends influencing supplier selection.

5. What are the main challenges in sourcing components for WAINUA?

Answer: Challenges include supply chain disruptions, maintaining regulatory compliance, high manufacturing costs, and the need for scalable production capabilities.

Sources
[1] Catalent Pharma Solutions, Corporate Reports, 2022.
[2] Ypsomed AG, Product Portfolio and Corporate Sustainability Reports, 2022.
[3] Industry Reports on Sustainable Medical Devices, 2023.

Suppliers and packagers for WAINUA (AUTOINJECTOR)