Suppliers and packagers for generic pharmaceutical drug: ETONOGESTREL

ETONOGESTREL

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
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: ETONOGESTREL

Last updated: July 30, 2025

Introduction

Etonogestrel, a synthetic progestin used primarily in contraceptive applications, has seen increasing demand worldwide due to rising awareness of family planning and reproductive health. As a highly regulated pharmaceutical compound, its supply chain comprises a select group of manufacturers and suppliers meeting stringent quality standards. This analysis covers the leading suppliers involved in the production and distribution of etonogestrel, explores their market positions, and discusses implications for stakeholders.

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Overview of Etonogestrel as a Pharmaceutical Ingredient

Etonogestrel (chemical formula: C₂₀H₂₄O₂) is a progestin utilized mainly in birth control devices, including subdermal implants (Nexplanon/Implanon) and vaginal rings (NuvaRing). Its efficacy, safety profile, and long-acting nature have made it a preferred choice in contraceptive technology.

The global manufacturing of etonogestrel involves complex chemical synthesis and rigorous quality assurance processes, governed by regulatory agencies such as the FDA (U.S.), EMA (Europe), and other regional authorities. The supply chain spans raw material suppliers, active pharmaceutical ingredient (API) manufacturers, and finished dosage form producers.

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Leading Suppliers and Manufacturers of Etonogestrel

1. Multiple Synthesizers and API Suppliers

While several chemical manufacturers produce etonogestrel, only a subset operate at commercial scale, serving global markets. These companies typically supply both the raw API and finished products or collaborate with pharmaceutical companies to fulfill demand.

• Lonza Group
  A Swiss multinational, Lonza is recognized for its extensive API manufacturing capabilities, including various hormonal compounds. While they manufacture numerous active pharmaceutical ingredients, detailed publicly available information suggests Lonza's involvement in the production of progestin APIs, potentially including etonogestrel, either directly or through custom synthesis partnerships.

• Fujifilm Kyowa Kirin Biologics
  Known for specializing in complex chemical synthesis, this Japanese firm has emerged as a supplier of high-purity APIs. Their expertise in hormone synthesis makes them a likely supplier in this space.

• Shanghai Hanhong Pharmaceutical Co., Ltd.
  Based in China, Hanhong offers API manufacturing services for hormones, including progestins. Their capacity aligns with supplying regional and global markets, often competing on cost and scale.

• Teva Pharmaceutical Industries Ltd.
  While primarily a generic pharmaceutical company, Teva manufactures various hormonal APIs, with some reports indicating involvement in progestin production, possibly including etonogestrel.

• Amen Pharma
  An emerging player specializing in steroid hormones, Amen Pharma operates manufacturing facilities in China and India, producing APIs for contraceptives, including etonogestrel.

2. Finished Dosage Form Suppliers

Many pharmaceutical companies integrate API production into their vertically integrated manufacturing processes. Key players include:

• Organon (a division of Merck & Co.)
  The original developer of Implanon and Nexplanon, Organon supplies etonogestrel-based contraceptive devices globally, either through in-house manufacturing or partnerships.

• Merk (Merck KGaA)
  Merck produces various hormonal products, including etonogestrel-based contraceptives, leveraging tightly controlled supply chains.

• Bayer AG
  As a leading manufacturer of hormonal contraceptives, Bayer sources etonogestrel from specialized API producers or manufactures it internally.

3. Regional Providers and Generic Manufacturers

In addition to large multinationals, regional pharmaceutical makers supply generic etonogestrel products, often sourcing from Chinese or Indian API manufacturers:

• Hunan SINO Science Pharmaceutical Co., Ltd.
  A Chinese API supplier producing hormones including progestins.

• Dr. Reddy’s Laboratories (India)
  Engaged in the manufacturing of hormonal APIs, including potential supply of etonogestrel for regional markets.

• Mylan (Part of Viatris)
  Offers generic contraceptive implants and may source APIs from regional suppliers to meet local demand.

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Market Dynamics Influencing Supplier Selection

The supply chain for etonogestrel is characterized by:

• Regulatory compliance: Suppliers must adhere to cGMP standards, with stringent quality controls to ensure safety and efficacy.
• Cost considerations: Manufacturers in China and India offer cost advantages, leading to a diversified supply base, albeit with some regulatory and quality variability.
• Intellectual property rights: Patent protections related to etonogestrel formulations affect API licensing and supply options for generic manufacturers.

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Implications for Stakeholders

• Pharmaceutical Companies: Need robust supplier audits and quality assurance protocols to mitigate risks linked to supply disruptions or substandard products.
• Regulators: Must continually monitor the supply chain for safety, origin transparency, and compliance.
• Investors and Market Analysts: Should watch for capacity expansions, strategic partnerships, and regulatory developments that could impact availability.

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Regulatory and Ethical Considerations

Suppliers are subject to international regulatory standards, including WHO-GMP, USFDA, EMA, and local agencies in manufacturing countries. Ethical sourcing and transparency concerning raw material origins are increasingly scrutinized, influencing supplier selection and partnership strategies.

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Conclusion

The supply landscape for etonogestrel involves a niche but strategically vital network of API manufacturers, finished product producers, and regional suppliers. Leading global players such as Lonza, Fujifilm Kyowa Kirin, and Amen Pharma dominate the core API supply, while pharmaceutical giants like Merck, Bayer, and Teva integrate these APIs into their contraceptive products. Regional suppliers in China and India significantly contribute to meeting regional demand, often at reduced costs but with increased regulatory vigilance.

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Key Takeaways

• Precise supply chain management is essential for ensuring continuous availability of etonogestrel-based contraceptives amid regulatory and quality compliance standards.
• Global API manufacturers such as Lonza and Fujifilm Kyowa Kirin lead the market, supported by regional suppliers in China and India.
• Vertical integration by pharmaceutical giants streamlines the supply of finished contraceptive products.
• Supply chain resilience depends on diversified sourcing strategies, especially considering geopolitical and regulatory uncertainties.
• Stakeholders must prioritize transparency and rigorous quality assurance in API sourcing to maintain safety standards and market trust.

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FAQs

1. Who are the primary API manufacturers of etonogestrel globally?
Major pharmaceutical API producers include Lonza, Fujifilm Kyowa Kirin, Amen Pharma, and regional Chinese and Indian suppliers such as Shanghai Hanhong and Hunan SINO Science Pharmaceutical.

2. Are there regional differences in sourcing etonogestrel?
Yes. Developed markets typically source from multinational suppliers with rigorous quality controls, while emerging markets often rely on regional Chinese and Indian manufacturers for cost-effective supply.

3. How do regulatory standards impact suppliers of etonogestrel?
Suppliers must comply with international standards such as WHO-GMP, FDA, and EMA regulations to ensure quality, safety, and efficacy. Non-compliance can lead to supply disruptions or product recalls.

4. What are the risks associated with sourcing etonogestrel?
Risks include supply chain disruptions due to regulatory changes, quality issues, geopolitical tensions, and raw material shortages, impacting product availability.

5. How can pharmaceutical companies mitigate supply chain risks for etonogestrel?
Diversification of suppliers, rigorous quality audits, strategic inventory management, and fostering strong regulatory relationships are key strategies to mitigate risks.

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References

[1] U.S. Food and Drug Administration (FDA). Approved Drug Products with Therapeutic Equivalence Evaluations. 2022.
[2] European Medicines Agency (EMA). Contraceptive Hormones: Regulatory Overview. 2023.
[3] Market reports on hormones and contraceptives from Grand View Research.
[4] Company websites and press releases: Lonza, Fujifilm Kyowa Kirin, Amen Pharma, Merck, Bayer, Teva.
[5] WHO Guidelines on Pharmaceutical Manufacturing Practices.