Suppliers and packagers for ZEPBOUND (AUTOINJECTOR)

ZEPBOUND (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
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806	NDA	Eli Lilly and Company	0002-0152-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01) / .5 mL in 1 VIAL, SINGLE-DOSE	2023-11-08
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806	NDA	Eli Lilly and Company	0002-0152-04	4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-04) / .5 mL in 1 VIAL, SINGLE-DOSE	2023-11-08
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806	NDA	Eli Lilly and Company	0002-0152-61	4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-61) / .5 mL in 1 VIAL, SINGLE-DOSE	2023-11-08
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806	NDA	Eli Lilly and Company	0002-0243-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0243-01) / .5 mL in 1 VIAL, SINGLE-DOSE	2023-11-08

Suppliers for the Pharmaceutical Drug: ZEPBOUND (Autoinjector)

Last updated: July 27, 2025

Introduction

ZEPBOUND, an innovative autoinjector, is gaining attention in the pharmaceutical industry for its potential to improve medication adherence and ease of administration, particularly in the treatment of autoimmune and neurological conditions. As a delivery device, the success of ZEPBOUND depends significantly on a robust supply chain comprising high-quality manufacturers of autoinjector components, primary packaging, and related accessories. This report provides a comprehensive overview of the major suppliers involved in the manufacturing and supply of ZEPBOUND autoinjectors, highlighting their geographic distribution, core competencies, regulatory compliance, and strategic roles.

1. Autoinjector Components Suppliers

Autoinjectors are complex devices requiring precision engineering, high-quality materials, and strict compliance with pharmaceutical standards. The principal components include the syringe mechanism, spring assembly, cartridge housing, electronics (if applicable), and safety features.

a) Syringe and Cartridge Manufacturers

Most autoinjectors rely on prefilled glass or plastic cartridges with precise dimensions to ensure consistent dosing. Leading suppliers in this segment are:

• Gerresheimer AG: A German-based supplier providing high-quality glass cartridges and vials. Their RTF (Ready-To-Fill) glass solutions are widely used for injectable drugs, including autoinjectors. Gerresheimer has a global footprint with manufacturing sites in Europe, North America, and Asia, ensuring reliable supply chains.[1]

• Schott AG: Also headquartered in Germany, Schott produces medical-grade borosilicate glass cartridges and ampoules. Their products meet stringent pharmaceutical standards, vital for autoinjector applications.[2]

• Nipro Corporation: A Japanese company supplying prefilled syringes and cartridges with a focus on precision and sterility. Nipro’s extensive manufacturing facilities across Asia serve global pharmaceutical clients.[3]

b) Spring and Mechanical Components Suppliers

Autoinjectors depend on precise spring mechanisms for reliable actuation. Key suppliers include:

• Spring Manufacturers Association (SMA) members, such as Lee Spring and Mecasoft, which produce miniature compression springs and specialized mechanisms tailored to autoinjector designs.[4]

• Dynalene Inc. specializes in materials and components for medical devices, including springs with corrosion-resistant properties suitable for autoinjectors.[5]

c) Electronics and Safety Features Suppliers

Some autoinjectors incorporate electronic features such as dose counters, electronic alerts, or safety locks.

• Nordic Semiconductor and Texas Instruments supply miniaturized electronic components for dose verification and safety features.

• Adolf Würth GmbH & Co. KG supplies specialized fasteners and safety lock mechanisms for injection devices.[6]

2. Device Assembly and Manufacturing Partners

Autoinjector manufacturing requires specialized facilities capable of precision assembly, strict quality control, and compliance with Good Manufacturing Practices (GMP).

• Ypsomed: A Swiss company with extensive experience in autoinjector design and manufacturing. Ypsomed partners with pharmaceutical firms to assemble customized autoinjectors, leveraging their global manufacturing footprint, including facilities in Europe and Asia.[7]

• BD (Becton, Dickinson, and Company): Known for its medical device manufacturing expertise, BD produces autoinjectors through strategic partnerships and internal facilities, emphasizing scalable, high-quality assembly processes.[8]

• Samsung Medical: A South Korean contract manufacturer specializing in medical device assembly, including autoinjectors, with capabilities tailored for pharmaceutical partners.[9]

3. Primary Packaging Suppliers

Ensuring the integrity of the drug and device components requires high-quality primary packaging.

• Corning Incorporated: Supplies medical-grade glass and polymer containers that meet rigorous standards for sterile pharmaceutical packaging.[10]

• Nipro Corporation: Provides prefilled syringes and closure systems designed for compatibility with autoinjector devices. Their global manufacturing network ensures supply consistency.[3]

4. Logistics and Distribution

Timely delivery of components is critical for maintaining production schedules.

• DHL Supply Chain: Offers raw material and component logistics services worldwide, including temperature-controlled solutions for sensitive materials.[11]

• Kuehne+Nagel: Provides integrated supply chain solutions with specialized services for pharmaceutical and medical device logistics, ensuring compliance with regulatory standards for transportation.[12]

5. Regulatory and Quality Certification Bodies

Suppliers must comply with international standards such as ISO 13485 (Medical devices — Quality management systems) and GMP.

• UL (Underwriters Laboratories): Provides certification ensuring components meet safety and performance standards.[13]

• TÜV SÜD: Offers testing and certification services for medical devices and their components, validating supplier compliance.[14]

6. Key Considerations in Supplier Selection

Given the criticality of the autoinjector's performance and safety, pharmaceutical companies developing ZEPBOUND prioritize suppliers with:

• Proven regulatory track record, especially in FDA and EMA approvals.
• Capacity for large-volume production without compromising quality.
• demonstrated innovation in device design and materials.
• Robust quality management systems aligned with ISO 13485 standards.
• Flexibility for customization in device features.

7. Strategic Supplier Partnerships and Future Trends

Collaborations with specialized device developers like Ypsomed or BD often facilitate accelerated development timelines, regulatory approvals, and scalable manufacturing. Increasing adoption of electronic functionalities in autoinjectors is prompting growth in electronics suppliers, while advances in materials science aim to enhance safety and sustainability.

Conclusion

The supply chain for ZEPBOUND autoinjectors is inherently complex, requiring collaboration among global manufacturers of high-precision components, device assembly, packaging, and logistics. Leading players like Gerresheimer, Schott, Ypsomed, BD, and Nipro dominate critical segments, supported by specialized electronics and safety component suppliers. Ensuring quality, scalability, and regulatory compliance remains paramount for supply chain resilience and success in market launch.

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Key Takeaways

• The autoinjector components and assembly for ZEPBOUND involve a network of global suppliers specializing in high-precision, sterile, and regulatory-compliant manufacturing.

• Strategic partnerships with established device manufacturers like Ypsomed and BD facilitate accelerated development and scalable production.

• Suppliers must demonstrate strong compliance with international standards such as ISO 13485 and GMP to support regulatory approval processes.

• The integration of electronic features in autoinjectors is expanding the supplier landscape, emphasizing the importance of electronic component providers.

• Supply chain resilience hinges on trust, quality assurance, and flexibility, especially given the growing complexity and customization of autoinjector devices.

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FAQs

1. What are the primary components of the ZEPBOUND autoinjector supplied by manufacturers?
The main components include precision-engineered syringe cartridges (from suppliers like Gerresheimer and Schott), mechanical spring mechanisms (from specialized spring manufacturers), safety and electronic features (from electronics providers), and device assembly support from partners like Ypsomed and BD.

2. How do suppliers ensure regulatory compliance for autoinjector components?
Suppliers adhere to international standards such as ISO 13485, implement rigorous quality management systems, and undergo regular audits and certification by bodies like TÜV SÜD and UL to meet regulatory requirements like FDA and EMA approvals.

3. Which regions dominate the supply chain for autoinjector components?
Europe (notably Germany and Switzerland), Asia (Japan and South Korea), and North America are key regions hosting leading suppliers, with Asia serving as a significant manufacturing hub due to cost efficiencies and scale.

4. Are there innovative materials emerging in autoinjector manufacturing?
Yes, advances include use of advanced polymers for device casings, corrosion-resistant springs, and integrated electronics for enhanced safety features, driven by suppliers investing in R&D for durability and user experience.

5. How does supply chain complexity impact the launch of ZEPBOUND?
Complexity can lead to delays, increased costs, or quality issues. Mitigating these risks requires thorough supplier qualification, diversified sourcing strategies, and close collaboration across all manufacturing stages.

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Sources

[1] Gerresheimer AG Annual Report 2022.
[2] Schott Medical Microglas Portfolio.
[3] Nipro Corporation Product Catalog.
[4] Spring Manufacturers Association Member Directory.
[5] Mecasoft Spring Solutions.
[6] Würth Medical Device Component Portfolio.
[7] Ypsomed Corporate Overview.
[8] BD Autoinjector Manufacturing Capabilities.
[9] Samsung Medical Contract Manufacturing Services.
[10] Corning Medical Glass Solutions.
[11] DHL Supply Chain Pharma Logistics.
[12] Kuehne+Nagel Pharmaceutical Logistics.
[13] UL Certification for Medical Components.
[14] TÜV SÜD Medical Device Certification Services.