NORETHINDRONE AND ETHINYL ESTRADIOL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Naari Pte	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-28	206864	ANDA	Naari Pte Limited	79929-007-07	3 BLISTER PACK in 1 CARTON (79929-007-07) / 1 KIT in 1 BLISTER PACK	2022-12-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Norethindrone and Ethinyl Estradiol are cornerstone hormonal agents used primarily in oral contraceptives, hormone therapy, and managing various gynecological conditions. Their global demand continues to rise due to increasing awareness of reproductive health and expanding contraceptive markets. Securing reliable suppliers for these compounds is essential for pharmaceutical manufacturers, healthcare providers, and market stakeholders aiming to ensure product quality, regulatory compliance, and supply chain stability.

Overview of Norethindrone and Ethinyl Estradiol

Norethindrone is a progestin component that mimics progesterone, suppressing ovulation and altering endometrial lining. It is used in contraceptive pills, menopausal hormone therapy, and therapeutic indications like abnormal uterine bleeding [1].

Ethinyl Estradiol is a synthetic estrogen that enhances contraceptive efficacy alongside progestins like Norethindrone. It regulates menstrual cycles, alleviates menopausal symptoms, and forms part of combined oral contraceptives [2].

Combined formulations of these drugs are available globally as oral contraceptives, with manufacturers adhering to stringent regulatory standards such as those set by the FDA, EMA, and other national agencies.

Key Criteria for Choosing Suppliers

Regulatory Compliance: Suppliers must comply with Good Manufacturing Practices (GMP), ISO standards, and national regulatory requirements.
Product Purity and Quality: High-grade APIs with >99% purity, validated manufacturing processes, and consistent batch quality.
Global Logistics Capability: Ability to supply worldwide with reliable delivery schedules and inventory management.
Cost-Effectiveness: Competitive pricing aligned with quality standards.
Traceability and Documentation: Comprehensive batch records, Certificates of Analysis (CoA), and regulatory documentation to ensure compliance.

Major Suppliers for Norethindrone and Ethinyl Estradiol

1. Major API Manufacturers

a. Hetero Labs Limited (India)
Hetero is a prominent global pharmaceutical API manufacturer that supplies high-quality Norethindrone and Ethinyl Estradiol. They hold several regulatory approvals, including US FDA, EMA, and Japanese PMDA certifications. Their manufacturing facilities adhere to international quality standards, making them a preferred supplier for many pharmaceutical companies globally [3].

b. Mylan N.V. (USA/International)
Mylan (now part of Viatris) has extensive manufacturing capabilities for hormonal APIs, including Ethinyl Estradiol and Norethindrone. Their facilities are GMP-certified, and they supply to leading pharmaceutical brands worldwide [4].

c. Sandoz (Novartis) (Switzerland)
Sandoz is a leader in generic pharmaceuticals, including hormonal APIs. Their rigorous quality controls and global distribution network make them a reliable supplier for Ethinyl Estradiol and Norethindrone [5].

d. Teva Pharmaceutical Industries Ltd. (Israel)
Teva produces hormonal APIs with manufacturing plants approved by international regulators. They are known for cost-effective solutions and consistent API quality [6].

e. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui offers APIs including Norethindrone and Ethinyl Estradiol, with increasing market share driven by competitive pricing and expanding regulatory authorizations in multiple jurisdictions [7].

2. Contract Manufacturing and OEMs

Several contract manufacturing organizations (CMOs) also produce hormonal APIs on behalf of brand companies:

Fareva (France): Offers development, manufacturing, and supply of hormonal APIs conforming to international standards.
Genscript (USA): Provides custom synthesis and manufacturing of active pharmaceutical ingredients, including hormonal compounds.
Yashraj Biotechnology (India): Specialized in steroid hormone synthesis and supply for pharmaceutical companies.

Emerging Markets and Niche Suppliers

Sichuan Holy Pharmaceutical Co., Ltd. (China): Focuses on niche steroid hormones, including Norethindrone.
Celltrion Inc. (South Korea): Engages in biosimilars but expanding into hormonal APIs with an emphasis on quality assurance.
Dr. Reddy’s Laboratories (India): A well-established manufacturer with a broad product portfolio that includes hormonal APIs catering to global markets.

Regulatory Considerations

Suppliers must meet regulatory standards such as:

GMP Certification: Ensures product safety, purity, and consistency.
FDA Approval (for US market): Suppliers approved by the FDA maintain strict controls.
EMA Certification: Essential for European market supplies.
ISO Certifications: ISO 9001, ISO 13485 (for medical devices), and ISO 14001 (environmental management).
And other regional certifications: TGA (Australia), PMDA (Japan).

Failure to meet these standards may result in supply chain disruptions or regulatory non-compliance, affecting market access and brand reputation.

Supply Chain and Risk Management

The reliance on a limited number of suppliers can pose risks such as geopolitical issues, manufacturing disruptions, or regulatory closures. Diversification across regions, including sourcing from both Indian, Chinese, and Western manufacturers, mitigates these risks.

Key Strategies Include:

Establishing dual or multiple sourcing agreements.
Conducting regular supplier audits and quality reviews.
Securing long-term supply contracts with performance clauses.
Monitoring global regulatory updates impacting API production.

Conclusion

The supply landscape for Norethindrone and Ethinyl Estradiol is characterized by established global manufacturers primarily based in India, China, Europe, and North America. Leading players such as Hetero Labs, Mylan, Sandoz, Teva, and Jiangsu Hengrui dominate due to their compliance with international standards and robust production capabilities.

Pharmaceutical firms seeking reliable sourcing should prioritize suppliers with proven GMP compliance, consistent quality, and strong regulatory track records. Strategic diversification and ongoing quality assurance are critical to maintaining a resilient supply chain for these fundamental hormonal compounds.

Key Takeaways

Leading suppliers include Hetero Labs, Mylan, Sandoz, Teva, and Jiangsu Hengrui.
Strong focus on regulatory compliance, product purity, and global logistics is essential.
Regional diversification mitigates supply risks and ensures market stability.
Engaging with reputable CMOs expands manufacturing capacity while maintaining quality.
Regular audits and compliance checks safeguard against regulatory and supply disruptions.

FAQs

1. What regulatory certifications should I verify before sourcing Norethindrone and Ethinyl Estradiol?
Ensure suppliers hold GMP certification, FDA approval (if supplying to the US), EMA certification for Europe, and ISO standards, along with regional approvals.

2. How do I assess the quality of hormonal APIs from new suppliers?
Conduct comprehensive audits, review Certificates of Analysis, perform independent testing, and evaluate supplier compliance history.

3. Are there regional differences in the production of these APIs?
Yes, Indian and Chinese manufacturers often offer competitive prices, while European and North American producers emphasize strict regulatory compliance and higher quality assurance.

4. Can I source these APIs via contract manufacturing organizations (CMOs)?
Yes, several CMOs specialize in hormone API synthesis. They provide manufacturing services, often with customizable formulations and scalable production capacity.

5. How does geopolitical stability impact API supply chains?
Geopolitical factors can influence manufacturing operations, export controls, and trade policies, potentially causing supply disruptions. Diversification and procurement from multiple regions are strategic mitigants.

References

[1] U.S. FDA. Norethindrone Tablets.
[2] EMA. Ethinyl Estradiol Product Information.
[3] Hetero Labs Ltd. Corporate Website.
[4] Viatris (formerly Mylan). API Supplier Portfolio.
[5] Sandoz. Hormonal API Quality Standards.
[6] Teva Pharmaceuticals. API Manufacturing Capabilities.
[7] Jiangsu Hengrui Medicine Co., Ltd. Official Reports.

Suppliers and packagers for NORETHINDRONE AND ETHINYL ESTRADIOL