Suppliers and packagers for estrace

estrace

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	ESTRACE	estradiol	CREAM;VAGINAL	086069	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3541-43	1 TUBE, WITH APPLICATOR in 1 CARTON (0093-3541-43) / 42.5 g in 1 TUBE, WITH APPLICATOR	2018-01-02
Allergan	ESTRACE	estradiol	CREAM;VAGINAL	086069	ANDA	Allergan, Inc.	0430-3754-14	36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR	2001-07-01
Allergan	ESTRACE	estradiol	CREAM;VAGINAL	086069	ANDA	A-S Medication Solutions	50090-2321-0	1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE	2001-07-01

Suppliers for the Pharmaceutical Drug: ESTRACE

Last updated: August 1, 2025

Overview of ESTRACE

ESTRACE is a widely prescribed hormone replacement therapy (HRT) primarily used to alleviate symptoms associated with estrogen deficiency, particularly in menopausal women. The active ingredient, estradiol, is a form of estrogen that restores hormonal balance. Manufactured by several pharmaceutical companies globally, ESTRACE is available in various formulations, including oral tablets, topical gels, patches, and injections. The demand for ESTRACE stems from its efficacy in managing menopausal symptoms such as hot flashes, vaginal atrophy, osteoporosis prevention, and genitourinary syndrome.

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Major Suppliers and Manufacturers

1. Warner Chilcott (now part of Actavis, a division of Allergan)

Warner Chilcott was a primary producer of ESTRACE in the United States before its acquisition by Actavis (later acquired by AbbVie). The company supplied ESTRACE oral tablets, a leading brand in the market. Their manufacturing facilities in the U.S. adhered to strict FDA Good Manufacturing Practices (GMP), ensuring high-quality standards. Post-merger, Allergan's global operations continue to produce and distribute ESTRACE in select markets under regulatory approvals.

2. Pfizer Inc.

Pfizer had historically supplied estradiol-based formulations, including ESTRACE, especially in North America and Europe. Pfizer's extensive global manufacturing infrastructure enabled reliable distribution. Though Pfizer sold its women’s health division in 2019, the rights for certain formulations, including ESTRACE, were transferred to other entities, impacting supply channels but maintaining the availability through authorized distributors.

3. Mylan (Now part of Viatris)

Mylan, prior to its merger with Pfizer’s Upjohn division to form Viatris in 2020, supplied generic estradiol products comparable to ESTRACE. Mylan's manufacturing footprint across Europe and North America, coupled with its extensive distribution network, made it a significant source of estradiol formulations. Post-merger, Viatris continues to supply generic versions under various brand names, often competing with branded ESTRACE.

4. Teva Pharmaceutical Industries

Teva is a prominent manufacturer of generic hormone replacement therapies, including estradiol formulations. Their product portfolio includes estradiol patches, tablets, and topical gels, serving as alternative sources of estradiol to ESTRACE. Their global manufacturing facilities and robust supply chain maintenance help ensure consistent availability.

5. Sandoz (A Novartis division)

Sandoz supplies generic hormone therapies, including estradiol topical gels and tablets, in several markets. Its strategic manufacturing locations in Europe and North America support steady supply and competitive pricing, making Sandoz a notable alternative or supplementary supplier for ESTRACE formulations.

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Regulatory and Market Dynamics Impacting Supply

Regulatory Approvals and Patent Status

ESTRACE's originator product, developed by Warner Chilcott (now part of AbbVie), enjoys patent protection in various countries, providing exclusivity during the initial launch phases. Once patents expire, generic manufacturers such as Mylan, Teva, and Sandoz enter the market, increasing competition and supply options.

Manufacturing Compliance and Quality Assurance

Suppliers must maintain compliance with GMP standards set by regulatory authorities such as the FDA (United States), EMA (European Union), and other national agencies to ensure safety and efficacy. Variations in quality standards across countries can influence procurement decisions, especially for companies requiring strict adherence to good manufacturing practices.

Supply Chain Challenges

Global supply chains for active pharmaceutical ingredients (APIs) used in estradiol production are susceptible to geopolitical tensions, trade restrictions, and raw material shortages. Recent disruptions, including those caused by the COVID-19 pandemic, have highlighted vulnerabilities within the supply chain for hormone therapies like ESTRACE.

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Emerging Suppliers and Market Trends

With patent expirations and increasing demand for cost-effective alternatives, several new entrants are emerging as suppliers of estradiol formulations. Biotechs focusing on biosimilar and OTC hormone therapies are gaining attention. Additionally, regions like India and China are expanding their manufacturing capacities of hormone APIs and finished dosages, potentially influencing future supply dynamics.

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Strategic Considerations for Procurement

• Regulatory status: Ensure supplier products have appropriate regulatory approvals for intended markets.
• Quality assurance: Verify GMP compliance, batch consistency, and stability data.
• Supply reliability: Assess supplier capacity, production yields, and contingency planning.
• Pricing and reimbursement: Consider economic factors and insurance coverage affecting access.
• Market exclusivity and patent landscape: Monitor patent statuses and potential entry of generics.

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Key Takeaways

• Primary suppliers of ESTRACE include Warner Chilcott (AbbVie), Mylan/Viatris, Pfizer, Teva, and Sandoz, each with varying regional footprints.
• Post-patent expiration has liberalized the market, increasing generic competition and expanding sourcing options.
• Quality and regulatory adherence remain critical, with suppliers needing strict GMP compliance to meet international safety standards.
• Supply chain resilience is vital amid dynamic geopolitical and economic conditions influencing API and finished product manufacturing.
• Emerging markets hold potential for new suppliers, especially with the growth of biosimilars and regional manufacturers in Asia.

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FAQs

1. Who are the main global manufacturers of ESTRACE?
The primary manufacturers historically included Warner Chilcott (now part of AbbVie), with additional sources from Mylan/Viatris, Pfizer, Teva, and Sandoz, depending on regional market dynamics.

2. Are there generic alternatives to ESTRACE?
Yes. Post-patent expiration, multiple generic estradiol formulations are available from companies like Mylan, Teva, and Sandoz, offering equivalent efficacy at lower costs.

3. How do regulatory standards influence suppliers for ESTRACE?
Suppliers must comply with GMP standards set by agencies like the FDA and EMA, ensuring product quality and safety. Compliance affects their ability to sell in specific markets.

4. What are the emerging trends affecting ESTRACE suppliers?
Increasing manufacturing capacity in Asia, the rise of biosimilars, and the need for reliable supply chains due to geopolitical issues are shaping supplier options and strategies.

5. How can healthcare providers ensure consistent ESTRACE supply?
By establishing relationships with multiple approved suppliers, verifying regulatory compliance, and monitoring supply chain stability, providers can mitigate shortages and ensure continuity of care.

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References

1. [1] U.S. Food and Drug Administration (FDA). Approved Drug Products. ESTRACE. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017007 (Accessed Jan 2023).
2. [2] AbbVie. ESTRACE Prescribing Information. https://www.rxabbvie.com/pdf/estrace.pdf (Accessed Jan 2023).
3. [3] Mylan (Viatris). Product portfolio of estrogen therapies. https://www.viatris.com/en/products (Accessed Jan 2023).
4. [4] Teva Pharmaceuticals. Hormone replacement therapy range. https://www.tevapharm.com (Accessed Jan 2023).
5. [5] European Medicines Agency (EMA). Market authorizations for hormone products. https://www.ema.europa.eu (Accessed Jan 2023).