Suppliers and packagers for IMPLANON

IMPLANON

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	IMPLANON	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: IMPLANON

Last updated: August 7, 2025

Introduction
IMPLANON, a long-acting reversible contraceptive implant, is a product marketed by industry leaders and manufactured through complex supply chains involving various raw materials, components, and packaging solutions. Understanding the suppliers involved in IMPLANON’s production is vital for pharmaceutical companies, healthcare providers, and industry stakeholders aiming to evaluate the supply chain's robustness, regulatory compliance, and potential vulnerabilities. This analysis explores the key suppliers, raw materials, manufacturing components, and related considerations within the IMPLANON supply ecosystem.

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Overview of IMPLANON Manufacturing
IMPLANON, developed by Merck (now MSD outside the U.S. and Canada), involves a sophisticated manufacturing process that includes the synthesis of etonogestrel (the active pharmaceutical ingredient, API), specialized implant delivery systems, biocompatible materials, packaging, and sterilization components. The product's success depends on a secure and compliant supply chain capable of delivering high-quality materials at scale.

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Key Components and Their Supplier Bases

1. Active Pharmaceutical Ingredient (API): Etonogestrel

Etonogestrel is the hormone responsible for the contraceptive effects of IMPLANON. The manufacturing of this API requires specialized chemical synthesis, often sourced from several API manufacturers with expertise in steroidal hormones.

• Leading API Suppliers:
  • Patheon (Thermo Fisher Scientific): Known for producing APIs, including hormonal compounds for contraceptives.
  • Samsung BioLogics: A prominent Asian API manufacturer with capabilities in steroid API production.
  • Dr. Reddy's Laboratories: An Indian pharmaceutical company with established API manufacturing lines for hormonal drugs.
  • Biocon: An Indian biopharmaceutical company with capabilities in hormone API synthesis.

Given the sensitivity of hormonal APIs, many pharmaceutical companies prefer suppliers with Good Manufacturing Practice (GMP) certification, robust quality control, and proven regulatory track records.

2. Silicon and Biocompatible Polymers for Implant Construction

IMPLANON’s implant is a small rod primarily composed of non-biodegradable, medical-grade silicone, which provides biocompatibility and durability.

• Common Suppliers:
  • Dow Corning (Dow Chemical): Supplies high-purity silicone elastomers used in implantable medical devices.
  • Wacker Chemie: Provides certified silicone materials for medical applications.
  • DuPont: Offers medical-grade polymers compatible with implant manufacturing.

3. Delivery System Components

The delivery mechanism involves a sterile, preloaded applicator, often made of high-grade plastics and metals, such as stainless steel or aluminum.

• Plastic Components:

  • BASF: Supplies polymers used in medical device manufacturing.
  • Sabic: Provides specialty plastics meeting medical standards.

• Sterile Packaging Materials:

  • Nippon Pillar Packing: Supplies sterilized packaging materials for pharmaceutical sterilization.
  • Kimberly-Clark: Offers sterilizable medical packaging solutions.

4. Sterilization and Quality Control Supplies

Sterilization of IMPLANON components usually involves ethylene oxide (EtO) or gamma irradiation, handled by specialized sterilization service providers.

• Suppliers of Sterilization Equipment/Services:
  • SteriPack: Provides contract sterilization services for medical devices.
  • Sodexo Sterile Processing: Offers sterilization and quality assurance for implantable devices.

5. Ancillary Materials and Packaging Components

Robust packaging ensures product stability and compliance with regulatory standards.

• Materials Suppliers:
  • AmerisourceBergen and McKesson: As distributors of pharmaceutical packaging materials.
  • West Pharmaceutical Services: Supplies rubber closures and sealing components.
  • Gerresheimer: Produces glass or polymer vials and prefilled syringes for drug delivery.

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Supply Chain Considerations

Regulatory Compliance and Quality Assurance
Suppliers for IMPLANON must meet stringent regulatory standards such as the US FDA, EMA, and other global agency requirements. Suppliers maintaining GMP certification, pre-approval audits, and robust quality controls are preferred.

Geographic Distribution
Major API and component suppliers are based primarily in the United States, Europe, and Asia—regions with mature pharmaceutical manufacturing infrastructures. Asian suppliers, notably from India and South Korea, dominate the API market due to cost efficiencies and manufacturing scale.

Supply Chain Risks
Risk factors include geopolitical issues, supply disruptions, raw material shortages, and regulatory changes. The COVID-19 pandemic underscored the importance of diversified supplier bases and strategic inventory management.

Vertical Integration and Outsourcing Strategies
Manufacturers often outsource components to contract manufacturing organizations (CMOs), enabling scalability and flexibility. Vertical integration is less common due to high R&D costs and regulatory hurdles.

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Key Industry Players Involved in IMPLANON’s Supply Network

Company Name	Role	Headquarters	Capabilities	Notable Certifications
Dow Corning (Dow Chemical)	Silicone supplier	USA	Medical-grade silicones	ISO 13485, GMP
BASF	Polymer provider	Germany	Medical-grade plastics	ISO 13485
Merck & Co.	End-user/Markets	USA	Product development, complex supply chain	GMP, regulatory approval
Samsung BioLogics	API manufacturing	South Korea	Hormonal APIs	GMP, ISO
Dr. Reddy’s Labs	API production	India	Steroidal APIs	GMP

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Conclusion
IMPLANON’s manufacturing relies on a sophisticated and integrated supply chain encompassing high-precision chemical synthesis, biocompatible materials, sterilization, and packaging. Suppliers are predominantly located in North America, Europe, and Asia, with strict adherence to regulatory standards critical to maintaining safety, efficacy, and quality. Continual risk mitigation and supplier diversification remain essential strategies in sustaining the supply chain's resilience.

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Key Takeaways

• The core suppliers for IMPLANON include API manufacturers specializing in hormonal compounds, silicone and polymer providers, and packaging/materials suppliers with medical-grade certifications.
• Regulatory compliance, GMP certification, and supply chain transparency are non-negotiable for suppliers involved in IMPLANON production.
• Asian API manufacturers have significant market share but require rigorous quality assurance to meet international standards.
• Diversification of supplier bases reduces risks associated with geopolitical and supply chain disruptions.
• Analyzing the supplier network offers strategic insights for industry stakeholders seeking to mitigate risks and optimize procurement strategies for IMPLANON.

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FAQs

1. Who are the primary API suppliers for IMPLANON?
Major API suppliers include Samsung BioLogics, Dr. Reddy’s Laboratories, and Biocon, specializing in steroid hormone synthesis with GMP standards.

2. What materials are used in the implant’s biocompatible components?
Medical-grade silicones from Dow Corning and Wacker Chemie form the core biocompatible material, chosen for durability and safety.

3. How does regulatory compliance influence IMPLANON’s supply chain?
Suppliers must uphold strict GMP and ISO certifications, undergo audits, and ensure traceability to meet FDA, EMA, and other global standards.

4. What role do sterilization service providers play?
They ensure the implant and its packaging are sterile, typically utilizing Ethylene Oxide or gamma irradiation, critical for patient safety.

5. Is there regional diversification in IMPLANON’s supply chain?
Yes. API manufacturers and component suppliers are predominantly based in North America, Europe, and Asia, balancing cost, quality, and regulatory considerations.

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Sources

1. [1] FDA Pharmaceutical Ingredient Manufacturing Standards.
2. [2] Dow Corning Medical-Grade Silicone Materials Specifications.
3. [3] Samsung BioLogics API Capabilities Overview.
4. [4] GMP Requirements for Steroid API Manufacturers.
5. [5] Smith & Nephew. Medical Device Material Suppliers and Standards.