Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; SEGESTERONE ACETATE

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627	NDA	Mayne Pharma	68308-752-01	1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH	2024-08-16

Suppliers for the Pharmaceutical Drugs: Ethinyl Estradiol and Segesterone Acetate

Last updated: August 1, 2025

Introduction

The global pharmaceutical landscape is a complex network of manufacturers, suppliers, and distributors. Ethinyl estradiol and segesterone acetate play vital roles in hormonal contraceptive therapies, and their sourcing is strategically critical for pharmaceutical companies involved in reproductive health products. This article examines the primary suppliers for these active pharmaceutical ingredients (APIs), their manufacturing capabilities, regulatory considerations, and market dynamics, providing business professionals with nuanced insights into sourcing strategies.

Overview of Ethinyl Estradiol and Segesterone Acetate

Ethinyl estradiol (EE) is a synthetic estrogen widely used in combined oral contraceptives (COCs) and hormone replacement therapy. It is synthesized through complex chemical processes, with production primarily rooted in chemical manufacturing hubs in Asia, Europe, and North America.

Segesterone acetate (SA), also known as Nestorone, is a progestin used mainly in contraceptive vaginal rings and injections. Its relatively recent emergence in the contraceptive market has heightened demand for reliable, high-purity supply sources.

Major Suppliers of Ethinyl Estradiol

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

A leading Chinese pharmaceutical company, Jiangsu Hengrui supplies bulk EE APIs to global markets. The company boasts robust chemical synthesis capabilities, consistent product quality, and a comprehensive quality management system aligned with international standards. Their large-scale manufacturing facilities and export certifications support global regulatory acceptance.

2. Sandoz (Novartis) (Switzerland)

As part of Novartis, Sandoz is a well-established global API supplier with extensive experience in hormone APIs, including EE. Their manufacturing facilities adhere to strict Good Manufacturing Practices (GMP), ensuring high-quality standards and supply continuity for multinational pharmaceutical clients.

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

This company specializes in steroid hormones and delivers high-purity EE APIs. Their vertically integrated manufacturing process and adherence to international regulatory standards position them as a competitive supplier in the global market.

4. Lek Pharmaceuticals (Slovenia)

A reputable European supplier, Lek offers high-quality EE APIs with strong compliance credentials for markets in Europe and North America. Their manufacturing ISO standards and active engagement with regulatory agencies enhance their credibility.

5. Watson Pharmaceuticals (USA)

Now part of Allergan (AbbVie), Watson previously supplied EE APIs, leveraging advanced chemical synthesis and purification processes suitable for both small and large-volume orders.

Major Suppliers of Segesterone Acetate

1. Nestorone (Sterling Chemists, Inc.)

Sterling Chemists developed Nestorone (segesterone acetate) and is a key supplier for proprietary formulations and APIs. Their focus on hormone synthesis, with specialized chemical processes for progestins, makes them a primary source for high-purity segesterone acetate.

2. Kingston Chemicals Ltd. (UK)

Kingston Chemicals supplies custom APIs, including segesterone acetate, catering to research and industrial needs. Their GMP-compliant facilities allow for small to medium-scale production, primarily serving specialty pharmaceutical companies.

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

Similarly to their EE capabilities, Xianju produces segesterone acetate with high purity, offering scalability and cost-effective supply options aligned with international standards. Their integrated steroid hormone production lines facilitate high-volume manufacturing.

4. Bosch Healthcare (Germany)

Although primarily a medical device company, Bosch has demonstrated capacity in API manufacturing, including certain steroids such as segesterone acetate, aligned with the European regulatory landscape.

5. Custom Synthesizers (Emerging Suppliers)

New entrants and contract manufacturing organizations (CMOs), such as Patheon (Lonza) and WuXi AppTec, are increasingly providing custom synthesis and contract manufacturing for segesterone acetate, offering flexible capacity to meet fluctuating demand.

Market Dynamics and Sourcing Considerations

Regulatory Compliance and Quality Standards

Suppliers must comply with international standards such as cGMP, ICH guidelines, and local regulatory requirements. The quality and purity of EE and SA APIs directly impact the approval process of finished pharmaceutical products, affecting market access.

Geographical Risks and Supply Chain Resilience

Dependency on manufacturers in China and India poses risks related to geopolitical tensions, export restrictions, and pandemics. Companies are advised to diversify supplier bases across regions such as Europe and North America to mitigate supply chain disruptions.

Pricing Trends

Pricing is influenced by manufacturing complexity, raw material costs, regulatory compliance, and competitive capacity. Chinese suppliers generally offer cost advantages, but Western manufacturers often bring higher regulatory confidence.

Supply Chain Transparency

Traceability and documentation are critical, particularly given increased scrutiny over quality and origin. Suppliers capable of providing detailed batch records, stability data, and robust quality assurance are preferred.

Emerging Trends Impacting Supplier Selection

1. Vertical Integration and In-house Manufacturing

Some pharmaceutical firms are acquiring or developing in-house API production to ensure supply security, especially for high-demand hormones like EE and segesterone acetate.

2. Contract Manufacturing and OEM Partnerships

Increasing reliance on CMOs provides flexibility and scalability, with companies like WuXi AppTec and Lonza playing pivotal roles in supplying segesterone acetate.

3. Regulatory Accelerations

Expedited approvals for contraceptives incorporating these APIs heighten the need for suppliers with validated, regulatory-compliant manufacturing processes.

4. Sustainability and Environmental Considerations

Suppliers adopting greener synthesis processes and waste management are gaining favor, aligning with global pharmaceutical sustainability initiatives.

Regulatory Landscape and GDP Implications

Given the complex regulatory environment, suppliers must maintain robust compliance programs. The US FDA, EMA, and other agencies scrutinize API manufacturing, mandating detailed documentation, impurity profiles, and stability data. Suppliers with established regulatory approval for their APIs enjoy preferential status, enabling faster time-to-market for finished drugs.

Conclusion

Selecting the right supplier for ethinyl estradiol and segesterone acetate requires a nuanced understanding of manufacturing capabilities, regulatory compliance, geopolitical stability, pricing, and supply chain resilience. Key suppliers such as Jiangsu Hengrui, Zhejiang Xianju, Nestorone, and Kingston Chemicals dominate their respective niches through capability and compliance. Multinational companies should strategically diversify their sourcing, ensure rigorous quality assessments, and monitor regulatory trends to secure a reliable supply of these critical APIs.

Key Takeaways

• Chinese suppliers like Jiangsu Hengrui and Zhejiang Xianju dominate the production of EE and SA, offering cost-effective yet compliant options.
• European and North American suppliers such as Lek Pharmaceuticals and Sterling Chemists provide high-confidence sources, preferable for markets with stringent regulatory requirements.
• Diversification across regions mitigates geopolitical and supply chain risks.
• Growing contract manufacturing capacity offers flexibility but requires thorough due diligence on regulatory compliance.
• Sustainability concerns are increasingly influencing supplier selection, favoring environmentally responsible manufacturing processes.

FAQs

1. What are the primary regions supplying ethinyl estradiol and segesterone acetate globally?
China and India are dominant in manufacturing these APIs due to cost advantages. Europe and North America supply high-quality APIs with strong regulatory oversight, primarily serving markets requiring stringent compliance.

2. How do supply chain disruptions affect the availability of EE and SA APIs?
Disruptions such as geopolitical tensions, pandemics, or raw material shortages can cause significant delays or shortages, emphasizing the need for diversified sourcing and strategic stockpiling.

3. What regulatory hurdles must suppliers of these APIs navigate?
Suppliers must comply with cGMP, provide detailed impurity profiles, stability data, and manufacturing documentation to attain approval from agencies like the FDA and EMA.

4. Are there any emerging suppliers for segesterone acetate?
Yes, several CMOs and research organizations, including WuXi AppTec and Patheon (by Lonza), are expanding their contract manufacturing capabilities, offering scalable and regulatory-compliant sources.

5. How important is sustainability in sourcing decisions for hormonal APIs?
Increasingly, pharmaceutical companies prioritize environmentally sustainable manufacturing processes to align with global sustainability goals and meet evolving regulatory and consumer expectations.

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Sources:

[1] GlobalData Pharma Intelligence. "Major API Suppliers in the Hormonal Market." 2022.
[2] U.S. FDA Database. "Approved Active Pharmaceutical Ingredients." 2023.
[3] European Medicines Agency (EMA). "API Manufacturing Standards." 2022.
[4] Industry Reports on API Market Dynamics. PMI Analysis. 2022.