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Last Updated: July 29, 2025

Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; NORETHINDRONE


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ETHINYL ESTRADIOL; NORETHINDRONE

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

ApplicantTradenameGeneric NameDosageNDANDA/ANDASupplierPackage CodePackageMarketing Start
Aurobindo Pharma NEXESTA FE ethinyl estradiol; norethindrone TABLET;ORAL 207535 ANDA Aurobindo Pharma Limited 65862-926-58 5 POUCH in 1 CARTON (65862-926-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 2017-02-02
Aurobindo Pharma NEXESTA FE ethinyl estradiol; norethindrone TABLET;ORAL 207535 ANDA Aurobindo Pharma Limited 65862-926-87 1 POUCH in 1 CARTON (65862-926-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 2017-02-02
Lupin Ltd KAITLIB FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203448 ANDA Lupin Pharmaceuticals, Inc. 68180-903-73 3 BLISTER PACK in 1 CARTON (68180-903-73) / 1 KIT in 1 BLISTER PACK * 4 TABLET, CHEWABLE in 1 BLISTER PACK (68180-358-74) * 24 TABLET, CHEWABLE in 1 BLISTER PACK (68180-356-74) 2021-02-07
Teva Branded Pharm NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 022573 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 52544-064-31 3 BLISTER PACK in 1 CARTON (52544-064-31) / 1 KIT in 1 BLISTER PACK 2011-12-23
Xiromed NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203371 ANDA Mylan Pharmaceuticals Inc. 0378-7308-53 3 POUCH in 1 CARTON (0378-7308-53) / 1 KIT in 1 POUCH (0378-7308-85) 2015-04-01
Xiromed NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203371 ANDA Xiromed, LLC 70700-306-85 3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK 2025-01-29
>Applicant>Tradename>Generic Name>Dosage>NDA>NDA/ANDA>Supplier>Package Code>Package>Marketing Start
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Suppliers for the Pharmaceutical Drugs: Ethinyl Estradiol and Norethindrone

Last updated: July 27, 2025

Introduction

Ethinyl estradiol and norethindrone are core components of many oral contraceptive formulations and hormone therapy regimens. The global demand for these pharmaceuticals remains high, driven by increasing awareness, expanded indications, and ongoing population growth. This article examines the leading suppliers of these APIs (Active Pharmaceutical Ingredients), analyzing manufacturing capacity, geographic distribution, quality standards, and market dynamics within this sector.

Overview of Ethinyl Estradiol and Norethindrone

Ethinyl estradiol (EE) is a synthetic estrogen widely used in contraceptive pills, hormone replacement therapy, and other hormonal treatments. Its potent estrogenic activity enhances the efficacy of combined oral contraceptives (COCs) and reduces the risk of ovarian cysts and endometrial pathology.

Norethindrone (NET) is a synthetic progestin used alone or in combination with EE to prevent pregnancy, manage menstrual disorders, and treat hormone deficiencies. Its structural modifications confer durable progestational activity with a favorable safety profile.

The combination of EE and norethindrone forms a cornerstone in modern oral contraceptives, positioning suppliers of these APIs as critical players in reproductive health markets.

Global Supply Landscape

The supply chain for ethynyl estradiol and norethindrone involves multiple key production hubs, primarily located in Asia and Europe. Leading entities in API manufacturing ensure compliance with international standards such as Good Manufacturing Practice (GMP) and possess extensive experience in pharmaceutical synthesis and regulatory navigation.

Major Suppliers of Ethinyl Estradiol

1. Jiangsu Hengrui Medicine Co., Ltd. (China)

As one of China's prominent pharmaceutical companies, Hengrui specializes in the synthesis of steroid hormones, including EE. Their facilities conform to GMP standards, and they export to numerous markets globally, including North America, Europe, and Asia.

2. Zhejiang Xianju Pharmaceutical Co., Ltd. (China)

Xianju is a significant API manufacturer with a dedicated division for hormone synthesis. Their EE production capacity is substantial, supported by state-of-the-art synthesis and purification processes.

3. Mylan (USA) / Pfizer

Although primarily a finished dosage form manufacturer, Mylan (now part of Viatris) has historically sourced high-quality EE APIs from certified Chinese and Indian suppliers to meet market demands.

4. Piramal Pharma Solutions (India)

Piramal supplies APIs across various therapeutic categories, including steroid hormones like EE. Their facilities in India support large-scale production aligned with international GMP standards.

5. Dr. Reddy’s Laboratories (India)

Reddy’s offers both intermediate and API manufacturing of ethynyl estradiol, catering to global pharmaceutical companies with strict regulatory controls.

Major Suppliers of Norethindrone

1. Sun Pharmaceutical Industries (India)

Sun Pharma produces norethindrone and its derivatives, leveraging advanced synthesis techniques to ensure high purity levels. Their global distribution channels facilitate widespread availability.

2. Leantech Pharmaceuticals (India)

Known for custom synthesis of steroid hormones, Leantech supplies high-quality norethindrone to pharmaceutical firms worldwide, emphasizing stringent regulatory compliance.

3. Mylan / Viatris

As noted, Mylan has historically been a key API supplier across reproductive hormone APIs, including norethindrone, with manufacturing capabilities in India and Europe.

4. Hankook Korus Pharm (South Korea)

Hankook KoruS provides specialty steroid hormones, including norethindrone, leveraging South Korea's advanced chemical synthesis infrastructure.

5. Sanofi (France)

While primarily a finished dosage form manufacturer, Sanofi consolidates supply chains by sourcing high-quality APIs for their hormonal therapy portfolio.

Supply Chain and Market Considerations

Manufacturing Trends

The majority of API production for EE and norethindrone occurs in India and China due to lower manufacturing costs and expanding chemical synthesis expertise. Yet, regulatory complexities, such as compliance with the US FDA and EMA standards, influence sourcing strategies.

Regulatory Environment

Suppliers with GMP-certified facilities and robust quality assurance frameworks enjoy competitive advantages. Increased scrutiny from health authorities, such as the U.S. FDA's inspection protocols, encourages ongoing infrastructure investments in API manufacturing.

Pricing Dynamics

The relatively high demand and complex synthesis pathways contribute to stable pricing for these APIs. However, geopolitical factors, trade policies, and raw material costs can impact supply volumes and pricing.

Supply Security

The concentration of manufacturing in specific regions exposes the market to risks such as supply disruptions, geopolitical tensions, and pandemic-related constraints. Diversification among suppliers is a prudent strategy for pharmaceutical companies to mitigate these risks.

Quality and Certification Standards

Top-tier suppliers adhere to internationally recognized standards:

  • GMP compliance
  • ISO certifications
  • EUGMP certification for European supply chains
  • Compliance with the US FDA's Drug Master File (DMF) requirements

This ensures API consistency, purity, and safety, critical for downstream formulation and regulatory approval processes.

Emerging Opportunities and Challenges

Emerging suppliers from Southeast Asia and Eastern Europe are investing in capacity expansion, aiming to capture market share. Additionally, process innovations, such as continuous synthesis, could improve yield and reduce costs, fostering competitive advantages.

However, challenges related to environmental regulations, intellectual property rights, and quality control remain significant hurdles for new entrants.

Summary of Key Suppliers

Supplier Location Notable Capabilities Certifications Market Focus
Jiangsu Hengrui China Large-scale steroid synthesis GMP, ISO Global
Zhejiang Xianju China API production & R&D GMP Global
Sun Pharma India Extensive steroid API portfolio GMP, WHO-GMP Global
Piramal Pharma India Contract manufacturing GMP Global
Hankook Korus Pharm South Korea Specialty steroids GMP Asia, Global

Conclusion

The landscape for suppliers of ethinyl estradiol and norethindrone remains concentrated but competitive. Chinese and Indian manufacturers dominate global supply, supported by their capacity, cost advantages, and compliance with international standards. Leading European and American pharmaceutical companies import APIs from these regions, emphasizing the importance of rigorous quality assurance.

Continued growth in reproductive health demand, coupled with regulatory tightening, underscores the importance of supply chain resilience, quality assurance, and innovation. Suppliers investing in advanced synthesis techniques and expanding capacity are best positioned to capitalize on future market opportunities.


Key Takeaways

  • Dominant Regions: China and India lead API manufacturing for EE and norethindrone, with growing contributions from Southeast Asia and Europe.
  • Quality Assurance: GMP compliance and regulatory certification are essential criteria for suppliers to maintain market trust and enable regulatory approval across markets.
  • Supply Chain Risks: Geopolitical factors, environmental regulations, and pandemic disruptions necessitate diversified sourcing strategies.
  • Market Dynamics: Cost advantages in Asia drive competitive pricing; however, stricter quality controls favor established suppliers.
  • Innovation & Capacity Expansion: Investment in process improvements and capacity growth is critical for suppliers to meet rising global demand.

FAQs

1. Which countries are the primary producers of ethinyl estradiol and norethindrone?
China and India dominate the production of both APIs, leveraging lower manufacturing costs and established chemical synthesis expertise. South Korea and European countries like France also contribute specialized manufacturing capacities.

2. What regulatory standards must API suppliers meet to supply global markets?
Suppliers are expected to comply with Good Manufacturing Practices (GMP), possess necessary certifications (ISO, EUGMP), and ensure transparency through documentation such as Drug Master Files (DMFs) for regulatory bodies like the US FDA and EMA.

3. How does supplier quality impact pharmaceutical formulation development?
High-quality APIs ensure safety, efficacy, and regulatory compliance of finished pharmaceutical products. Variability or contamination risks associated with substandard APIs can delay approvals and increase costs.

4. Are there any emerging suppliers aiming to enter the market?
Yes, companies in Southeast Asia and Eastern Europe are investing in capacity and technology to serve growing demand, though establishing regulatory credibility remains a key challenge.

5. What are the future trends impacting the API supply of EE and norethindrone?
Advancements in chemical synthesis, automation, and process optimization will improve yields and reduce costs. Additionally, regulatory scrutiny will favor suppliers with proven compliance and consistent quality.


References

[1] Global API Market Research, 2022.
[2] U.S. Food and Drug Administration (FDA), API Regulatory Guidance.
[3] European Medicines Agency (EMA), GMP Standards for APIs.
[4] Industry Reports on Asian API Manufacturing Capacities, 2021.
[5] Company Websites and Press Releases of Jiangsu Hengrui, Zhejiang Xianju, Sun Pharma, and others.

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