Suppliers and packagers for nexplanon

nexplanon

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529	NDA	Organon LLC	78206-145-01	1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK	2021-06-01

Suppliers for the Pharmaceutical Drug: NEXPLANON

Last updated: July 27, 2025

Introduction

NEXPLANON, a widely used subdermal contraceptive implant, represents a significant sector within pharmaceutical manufacturing focused on long-acting reversible contraception (LARC). Developed and marketed by Merck & Co., Inc., NEXPLANON’s manufacturing and supply chain involve a complex network of suppliers responsible for raw materials, components, and packaging. Understanding these suppliers is essential for stakeholders, including healthcare providers, investors, and regulatory agencies, to assess risks and ensure consistent product availability.

Overview of NEXPLANON

NEXPLANON is a flexible, matchstick-sized, implantable device containing etonogestrel, a synthetic progestin, designed for continuous contraception over three years [1]. It is inserted subdermally in the inner arm and releases hormones steadily. The manufacturing process demands high precision, sterile conditions, and adherence to stringent regulatory standards, requiring a diverse supplier network.

Raw Material Suppliers

Etonogestrel Supply Chain

The core active pharmaceutical ingredient (API) in NEXPLANON, etonogestrel, is a synthetic hormone synthesized through complex chemical processes. The primary suppliers for etonogestrel include:

• Shanghai Fosun Pharmaceutical (China): Known for manufacturing hormones, Fosun Pharma supplies APIs to various contraceptive products, including etonogestrel. Their facilities are GMP-certified, ensuring compliance with international standards [2].

• BASF SE (Germany): A key global chemical supplier, BASF provides intermediates used in synthesizing etonogestrel. Their extensive chemical expertise ensures consistency and purity required for hormone APIs [3].

• Seikagaku Corporation (Japan): Specializes in hormone synthesis and can supply intermediates or APIs, contributing to the pharmaceutical grade of etonogestrel [4].

Polymers and Devices

• Polymethyl Methacrylate (PMMA): Used as the implant core material; suppliers include Mitsubishi Chemical (Japan) and Evonik Industries (Germany), both providing medical-grade polymers compliant with ISO standards [5].

• Silicone Rubber: Employed in some components for flexibility and biocompatibility, supplied by companies like Dow Corning (USA) and Wacker Chemie (Germany).

Device Components and Packaging Suppliers

Implant Casing

• Manufactured primarily from biocompatible polymers, with suppliers such as SABIC Innovative Plastics providing polycarbonate and related materials, adhering to USP and ISO standards for medical devices.

Sterile Packaging Material Suppliers

• Gerresheimer (Germany): Supplies prefilled syringes, sealed vials, and sterile blister packs, ensuring product integrity throughout shelf life.

• Stevanato Group (Italy): Provides flexible, sterile packaging solutions, including sterilizable containers essential for device sterilization post-manufacture.

Adhesives and Sealants

• Suppliers such as 3M (USA) and Henkel (Germany) produce medical-grade adhesives used in assembly and insertion aids, adhering to regulatory standards.

Manufacturing and Contract Manufacturing Organizations (CMOs)

Given the complexity, Merck often collaborates with CMOs to produce NEXPLANON components and final assembly:

• Vetter Pharma International (Germany): Has played roles in pre-filled device manufacturing and packaging.

• Catalent Pharma Solutions (USA): Provides aseptic filling and packaging services for NEXPLANON components.

Quality Control and Regulatory Suppliers

• Instrumentation suppliers: Companies like Thermo Fisher Scientific and Agilent Technologies supply analytical instruments essential for quality testing, such as HPLC and spectrometry.

• Sterilization Service Providers: Sterilization is critical, with suppliers like Nordion (Canada) providing gamma irradiation services aligning with regulatory standards.

Supply Chain Challenges and Considerations

The supply chain for NEXPLANON faces challenges such as geopolitical tensions affecting sourcing (notably from China and other Asian suppliers), raw material shortages during global disruptions, and stringent regulatory requirements for medical devices and APIs. Merck’s diversification of supplier base and maintaining strategic stockpiles mitigate potential bottlenecks.

Regulatory and Certification Standards

Suppliers of NEXPLANON components and raw materials must adhere to acute regulatory standards, including:

• GMP (Good Manufacturing Practices): Ensuring quality, safety, and efficacy (per FDA, EMA standards).

• ISO 13485: For medical device manufacturing quality management systems.

• USP and EP Standards: For pharmaceutical ingredients ensuring purity and consistency.

Compliance with these standards ensures product safety, regulatory approval, and market access.

Recent Developments

Recent strategic efforts focus on diversifying suppliers amidst geopolitical trade tensions and responding to COVID-19-induced supply chain disruptions. Merck emphasizes collaboration with regional suppliers and increased qualification of alternative sources, all while prioritizing compliance with international standards.

Conclusion

The supply chain for NEXPLANON encompasses a global network of specialized suppliers providing active pharmaceutical ingredients, medical-grade polymers, device components, packaging, and sterilization services. This network assures high-quality and reliable production aligned with stringent regulatory standards. As the demand for long-acting contraceptive options grows, the resilience and transparency of this supply chain will be pivotal for maintaining consistent product availability and meeting global health needs.

Key Takeaways

• The core API, etonogestrel, is sourced from multiple global pharmaceutical and chemical suppliers, emphasizing diversification to mitigate risks.
• Material suppliers for implants and packaging are primarily based in Europe and Asia, with high regulatory compliance requirements.
• Contract manufacturing organizations contribute significantly to production capacity and ensure sterile, high-quality outputs.
• Maintaining regulatory compliance and managing geopolitical risks are ongoing priorities for supply chain sustainability.
• Strategic supplier qualification and diversification are essential in ensuring robust and resilient supply channels for NEXPLANON.

FAQs

1. Who are the primary API suppliers for NEXPLANON?
The primary API suppliers include Shanghai Fosun Pharmaceutical, BASF SE, and Seikagaku Corporation, all providing high-purity etonogestrel suitable for pharmaceutical use [2][3][4].

2. What materials are used for the implant device?
The implant core is typically made from biocompatible polymers such as polymethyl methacrylate (PMMA), supplied by Mitsubishi Chemical and Evonik Industries. The outer casing may incorporate medical-grade polycarbonate from SABIC or similar firms.

3. How does Merck ensure supplier quality compliance?
Merck enforces strict qualification processes, audits, and adherence to GMP and ISO standards among its suppliers. Regulatory inspections and ongoing quality assessments are integral to this process.

4. Are there regional differences in the supply chain?
Yes. Ingredien ts and components are sourced globally, with key regions including North America, Europe, and Asia. Diversification helps mitigate regional disruptions.

5. What challenges does the NEXPLANON supply chain face?
Crucial challenges include geopolitical tensions affecting Asian API supply, raw material shortages during global crises like COVID-19, and stringent regulatory standards requiring continuous compliance.

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Sources

[1] U.S. Food and Drug Administration (FDA). NEXPLANON (etonogestrel implant) [FDA Label].
[2] Shanghai Fosun Pharmaceutical Group. Corporate Website.
[3] BASF SE. Hormone Intermediates and APIs Portfolio.
[4] Seikagaku Corporation. Product Pipeline and API Manufacturing.
[5] Evonik Industries. Medical-grade Polymers for Implants.