Suppliers and packagers for ELESTRIN

ELESTRIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813	NDA	Viatris Specialty LLC	0037-4801-70	2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)	2014-06-02

Suppliers for the Pharmaceutical Drug: ELESTRIN

Last updated: August 7, 2025

Introduction

ELESTRIN (generic name: estradiol valerate) is a synthetic estrogen used primarily in hormone replacement therapy (HRT), treatment of menopausal symptoms, and certain hormonal disorders. As a critical component in various formulations, understanding its global supplier landscape is essential for pharmaceutical companies, healthcare providers, and investors aiming to ensure supply chain resilience and compliance with regulatory standards. This analysis provides a comprehensive overview of key suppliers for ELESTRIN, highlighting manufacturing origins, market share, quality benchmarks, and regulatory considerations.

Manufacturing Sources and Global Supply Chain

The primary suppliers of estradiol valerate, including ELESTRIN, are concentrated in regions with advanced pharmaceutical manufacturing capabilities—predominantly India, China, and Europe. These regions host a mix of multinational and contract manufacturing organizations (CMOs) that produce active pharmaceutical ingredients (APIs) at scale.

India’s Role as a Major Supplier

India’s pharmaceutical sector plays a dominant role in the global supply of hormone APIs, including estradiol valerate. Indian pharmaceutical giants like Dr. Reddy’s Laboratories, Cipla, and Sun Pharmaceutical Industries manufacture estradiol valerate APIs utilized in diverse hormone therapy products. These companies benefit from cost advantages, robust manufacturing infrastructure, and capacity to meet international quality standards. Several Indian API producers are approved by global regulators such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enabling export to North America and Europe.

Chinese API Manufacturers

China’s pharmaceutical industry similarly supplies estradiol valerate, often through large CMOs like Zhejiang Hisun Pharmaceutical, Bayer China, and Shanghai Fosun Pharmaceutical. Chinese manufacturers have expanded their capabilities to meet international quality standards, driven by the need to comply with stringent regulatory requirements and grow export markets. However, supplier qualification and certification processes remain critical for importers to mitigate risks related to quality inconsistency.

European and North American Suppliers

European nations, such as Germany and Switzerland, host established manufacturers producing high-purity estradiol valerate APIs. Companies like Jerini (Germany) and Novartis have historically produced hormone APIs with a focus on quality and regulatory compliance, although their supply volumes are comparatively limited due to higher production costs. North American suppliers are typically smaller or contract manufacturers sourcing APIs from India or China, reprocessing or packaging in-house for local markets.

Contract Manufacturing Organizations (CMOs)

The complex nature of hormone API production favors outsourcing to specialized CMOs. Globally recognized CMOs, such as:

• Recipharm (Sweden): Offers hormone API manufacturing with a focus on quality certification and regulatory compliance.
• Baxter BioPharma Solutions (USA): Provides API validation and custom synthesis services.
• Hainan Yew Pharmaceutical (China): Supplies bulk estradiol derivatives to international markets.

CMO partnerships are driven by operational scale, technical expertise, and stringent quality standards.

Regulatory and Quality Standards

Suppliers of ELESTRIN must adhere to cGMP (current Good Manufacturing Practices) standards, FDA and EMA inspections, and undergo qualification processes before their APIs can be incorporated into approved pharmaceutical products. Certificates of Suitability (CEP), Drug Master Files (DMF), and Drug Substances Master Files (DSMF) are critical documentation for regulatory compliance.

Supply Chain Risks and Considerations

Dependence on a limited pool of suppliers, particularly in high-volume countries like India and China, exposes stakeholders to risks such as regulatory disruptions, geopolitical instability, and raw material shortages. Recent global events, including the COVID-19 pandemic, have underscored the importance of diversifying supplier bases and maintaining strategic inventory reserves.

Key Suppliers Summary

Supplier Region	Major Companies	Notable Capabilities	Regulatory Certifications
India	Dr. Reddy’s, Cipla, Sun Pharma	Large-scale API production, export capability	FDA, EMA approvals, ISO standards
China	Zhejiang Hisun, Shanghai Fosun	Cost-effective, increasing quality compliance	Chinese GMP, WHO-GMP certifications
Europe	Jerini, Novartis	High purity API manufacturing	EMA certification, CEPs
North America	Contracted CMOs like Baxter, Recipharm	Custom synthesis, validation	FDA-approved facilities

Concluding Remarks

The supplier landscape for ELESTRIN’s active ingredient, estradiol valerate, remains predominantly concentrated in India and China, with established European manufacturers maintaining high-quality standards. The reliance on these regions necessitates robust qualification processes, diverse sourcing strategies, and ongoing regulatory vigilance to ensure a secure supply chain.

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Key Takeaways

• Indian and Chinese manufacturers are the primary global suppliers of estradiol valerate APIs used in ELESTRIN formulations.
• Regulatory compliance (FDA, EMA, GMP certifications) is essential for supplier qualification and product approval.
• Supply chain diversification minimizes risks associated with geopolitical, pandemic, or regulatory disruptions.
• Partnerships with reputable CMOs enhance manufacturing capacity, quality, and compliance.
• Monitoring regulatory developments and maintaining strategic inventories safeguard against supply shortages.

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FAQs

1. Who are the leading pharmaceutical companies supplying estradiol valerate APIs for ELESTRIN?
Major suppliers include Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries in India, Zhejiang Hisun Pharmaceutical and Shanghai Fosun Pharmaceutical in China, and specialized European manufacturers like Jerini. Many of these companies hold certifications from global regulators, ensuring quality and compliance.

2. What regions dominate the production of estradiol valerate?
India and China are the primary producers, accounting for most of the global API manufacturing, with Europe maintaining a niche focus on high-purity, regulated supplies.

3. How do regulatory standards impact API suppliers for ELESTRIN?
Suppliers must meet cGMP standards, obtain certifications like CEPs and DMFs, and pass inspections from authorities like the FDA and EMA. These standards ensure API quality, safety, and international market access.

4. What risks are associated with dependence on specific suppliers or regions?
Risks include regulatory delays, geopolitical instability, raw material shortages, and disruptions caused by global crises, emphasizing the need for diversified sourcing and strategic stockpiling.

5. How can pharmaceutical companies ensure a reliable supply of estradiol valerate?
Companies should qualify multiple approved suppliers, establish long-term partnerships with CMOs, monitor regulatory changes, and maintain inventory buffers to mitigate supply chain vulnerabilities.

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Sources:

[1] European Medicines Agency – API Manufacturing Standards and Certifications.
[2] Indian Pharmaceutical Alliance – API Production Capabilities.
[3] Chinese State Food and Drug Administration – Regulatory Standards for Hormone APIs.
[4] Global Industry Analysts – Market Trends in Active Pharmaceutical Ingredients.
[5] U.S. Food and Drug Administration – CMO and API Registration Guidelines.