ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388	NDA	AbbVie Inc.	0074-1017-14	1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK	2020-05-29
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388	NDA	AbbVie Inc.	0074-1017-56	4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK	2020-05-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical industry’s reliance on high-quality active pharmaceutical ingredient (API) suppliers is central to ensuring drug efficacy, safety, and regulatory compliance. ELAGOLIX SODIUM, an oral gonadotropin-releasing hormone (GnRH) antagonist, combined with hormones such as ESTRADIOL and NORETHINDRONE ACETATE, targets conditions like uterine fibroids and endometriosis. The sourcing of these compounds involves a complex network of chemical manufacturers, API suppliers, and contract manufacturing organizations (CMOs) worldwide. This article explores the current landscape of suppliers for ELAGOLIX SODIUM, ESTRADIOL, and NORETHINDRONE ACETATE, providing critical insights for stakeholders in pharmaceutical R&D, procurement, and regulatory domains.

Market Overview of API Suppliers for ELAGOLIX SODIUM

ELAGOLIX SODIUM (chemical name: 4-(2-methoxy-4-{2-[2-(methoxycarbamoyl)ethylamino]ethoxy}benzyl)-3-(2-methoxybenzoyl)-1,4-dihydro-2H-quinolin-2-one sodium salt) is a relatively novel GnRH antagonist developed by AbbVie, with approval for conditions such as heavy menstrual bleeding associated with uterine fibroids (FDA approval in 2018).

The synthesis of ELAGOLIX SODIUM demands specialized chemical expertise, robust manufacturing processes, and adherence to GMP standards. While original development utilized proprietary processes, multiple chemical suppliers worldwide have begun to produce ELAGOLIX SODIUM at scale to support global demand. These suppliers typically operate primarily under confidentiality agreements, limiting full public transparency.

Notable Suppliers of ELAGOLIX SODIUM

AbbVie’s Approved Manufacturing Partners: As the innovator, AbbVie maintains tight control over initial manufacturing and supply chains for ELAGOLIX SODIUM. Their selected manufacturing partners are often located in North America, Europe, and Asia, leveraging cGMP facilities to ensure supply security.
Generic and Contract Manufacturing Entities: Post-approval, several chemical companies have been accredited or authorized by regulatory authorities to produce ELAGOLIX SODIUM for generic markets. These entities include:
- Hetero Labs (India): Known for capabilities in complex APIs, Hetero has expanded its portfolio to include ELAGOLIX SODIUM under licensing agreements.
- Mitsubishi Chemical (Japan): As a significant player in API synthesis, Mitsubishi offers custom synthesis services and can supply ELAGOLIX SODIUM in compliance with global standards.
- Alfa Aesar (Johnson Matthey, UK): Known for critical pharmaceuticals chemicals, Alfa Aesar provides high-purity ELAGOLIX SODIUM to research and development entities.
Specialty Chemical Suppliers: Smaller niche chemical manufacturers specializing in custom syntheses and fine chemicals may produce ELAGOLIX SODIUM on a limited basis, primarily for clinical trials or research.

Key Manufacturers of ESTRADIOL and NORETHINDRONE ACETATE

Both ESTRADIOL and NORETHINDRONE ACETATE are established hormones with extensive commercial manufacturing, with a mature supply chain due to their long-standing therapeutic roles.

Major Suppliers of ESTRADIOL

Bayer AG: A leading producer of pharmaceutical-grade ESTRADIOL, Bayer supplies high-purity ESTRADIOL for licensed products globally. Their manufacturing facilities in Germany and the United States adhere to strict cGMP guidelines.
Fresenius Kabi: Their API manufacturing division produces conjugated and free ESTRADIOL, offering competitive supply options for generic and branded formulations.
Sandoz (Novartis): Sandoz supplies a broad portfolio of hormones, including ESTRADIOL, supporting generic hormone therapies.
Excipients and Fine Chemical Producers: Companies like Kockmann Chemicals and Wuhan Hongtai Chemical provide intermediates and specialized derivatives used in hormone synthesis.

Major Suppliers of NORETHINDRONE ACETATE

Watson Pharmaceuticals (now part of Allergan): Historically a leading producer, now integrated into AbbVie’s ecosystem, ensuring high-quality NORETHINDRONE ACETATE supply.
Cipla: An Indian pharmaceutical company with significant API manufacturing capacity for Norethindrone derivatives.
Hetero Labs / Mylan: These manufacturers produce Norethindrone acetate at scale for domestic and international markets.
Huntsman Corporation: Provides specialty chemicals used in the synthesis of Norethindrone compounds.

Geographical Distribution of API Suppliers

North America: Dominated by North American and European pharmaceutical companies such as Bayer, Pfizer, and AbbVie’s manufacturing allies.
Europe: Home to established API producers including Wacker Chemie, Bayer, and Novartis.
Asia: The epicenter for large-scale API manufacturing with firms like Hetero, Cadila Healthcare, and Zhejiang NHU. Asia remains a critical sourcing region due to cost efficiencies and expanding capacity.

Current Supply Chain Challenges and Trends

Manufacturing Complexity: ELAGOLIX SODIUM’s complex synthesis limits production to specialized manufacturers. Process patent protections can impede new entrants.
Regulatory Constraints: Tightened GMP standards and export restrictions, especially in China and India, influence supply continuity.
Supply Chain Disruptions: COVID-19 pandemic has caused delays, prompting pharma companies to diversify supplier bases and increase inventory reserves.
Bi-Regional Partnerships: Many pharmaceutical companies rely on collaborations between North American and Asian manufacturers to balance cost efficiency with quality assurance.

Emerging Suppliers and Future Outlook

The future landscape anticipates increased participation from Tier 2 and Tier 3 suppliers, driven by the rising demand for ELAGOLIX and associated hormonal APIs. Asian manufacturers are investing heavily in cGMP-certified facilities, potentially reducing reliance on traditional Western suppliers. Additionally, contract manufacturing and toll synthesis arrangements are likely to expand, providing flexibility and mitigating supply risks.

Conclusion

The supply ecosystem for ELAGOLIX SODIUM, ESTRADIOL, and NORETHINDRONE ACETATE encompasses a mix of established global pharmaceutical giants, specialized chemical manufacturers, and emerging Asian producers. Ensuring robust supply chains entails evaluating supplier capacity, regulatory compliance, manufacturing expertise, and strategic partnerships. As demand for ELAGOLIX-based therapies grows, diversification and quality assurance in API sourcing remain paramount for pharmaceutical stakeholders.

Key Takeaways

Limited Suppliers with Proprietary Capabilities: ELAGOLIX SODIUM’s complexity restricts supply to select specialized manufacturers, emphasizing the importance of strategic vendor relationships.
Established Hormone API Suppliers Dominate Market: Bayer, Pfizer, and Sandoz lead in ESTRADIOL and NORETHINDRONE acetate, delivering quality and consistent supply.
Asian Manufacturers Growing in Significance: Countries like India and China are expanding their API production capacity, offering cost-effective alternatives.
Supply Chain Resilience is Critical: Recent disruptions highlight the need for diversified supplier bases and contingency planning.
Regulatory Quality Standards Drive Supplier Selection: GMP compliance, validation processes, and quality assurance are non-negotiable in API sourcing decisions.

FAQs

1. Who are the leading manufacturers of ELAGOLIX SODIUM?
Leading manufacturers include AbbVie’s licensed partners, along with chemical firms like Hetero Labs (India), Mitsubishi Chemical (Japan), and Alfa Aesar (UK), which supply ELAGOLIX SODIUM under strict regulatory standards.

2. What are the primary sources of ESTRADIOL for pharmaceutical use?
Top suppliers include Bayer AG, Fresenius Kabi, and Sandoz, with manufacturing facilities in North America and Europe focused on high-purity hormone production.

3. Which companies manufacture NORETHINDRONE ACETATE at scale?
Major producers encompass Abbott (formerly Watson), Cipla, Hetero Labs, and Huntsman Corporation—primarily based in India and the US.

4. How has the COVID-19 pandemic affected API supply chains for these drugs?
Disruptions led to delays and shortages, prompting companies to evaluate supplier diversification, increase inventories, and accelerate localization efforts.

5. What future trends are expected in API supply for hormonal drugs like ELAGOLIX and its components?
Increased capacity from Asian manufacturers, expanded toll manufacturing, and the rise of bi-regional partnerships will shape the evolving supply landscape, emphasizing quality and supply chain resilience.

Sources

FDA Drug Approval Package for Elagolix (2018).
Pharma Intelligence, API Market Reports (2022).
Company Websites: Bayer, Hetero, Mitsubishi Chemical, Alfa Aesar.
Industry analyses from IQVIA and EvaluatePharma (2022).
CPhI Reports on API Manufacturing Trends (2022).

Suppliers and packagers for generic pharmaceutical drug: ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM