Suppliers and packagers for DUAVEE

DUAVEE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-1123-12	1 POUCH in 1 CARTON (0008-1123-12) / 2 BLISTER PACK in 1 POUCH / 15 TABLET, FILM COATED in 1 BLISTER PACK	2013-10-03
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247	NDA	U.S. Pharmaceuticals	63539-122-07	1 BLISTER PACK in 1 CARTON (63539-122-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2013-11-15

Last updated: August 1, 2025

ppliers for the Pharmaceutical Drug: DUAVEE

Introduction
DUAVEE (estradiol/nomegestrol acetate) is a hormonal therapy used primarily for the treatment of menopausal symptoms and uterine health management. As a proprietary combination product, DUAVEE’s supply chain involves multiple critical components, from active pharmaceutical ingredient (API) sourcing to finished drug manufacturing and distribution. Understanding the key suppliers across this spectrum is essential for stakeholders assessing supply chain stability, regulatory compliance, and market readiness.

Active Pharmaceutical Ingredient (API) Suppliers

1. Estradiol API Suppliers
   Estradiol, a primary active component of DUAVEE, is a widely manufactured estrogen used in hormone replacement therapies. Major global API producers supply estradiol, with prominent players including:

   • Siegfried AG (Germany): Known for high-quality API manufacturing, Siegfried supplies estradiol APIs to various pharmaceutical firms globally, benefiting from advanced synthesis capabilities and stringent quality controls [1].
   • Xianju Pharmaceutical Co., Ltd. (China): A significant Chinese producer offering cost-effective estradiol APIs, frequently exported to international markets. Their compliance with Good Manufacturing Practices (GMP) has improved, expanding their supplier credibility [2].
   • Wockhardt Ltd. (India): An established Indian pharmaceutical API supplier with extensive experience in hormone APIs, including estradiol, supporting global demand with competitive pricing [3].

2. Nomegestrol Acetate API Suppliers
   Nomegestrol acetate is a synthetic progestogen essential for DUAVEE’s efficacy in hormone therapy. Leading API manufacturers include:

   • IBSA Farmaceutici (Italy): Renowned for high-purity hormone APIs, IBSA supplies nomegestrol acetate with proven GMP compliance, underscoring quality assurance for licensed products [4].
   • Zhejiang NHU Co., Ltd. (China): A rapidly expanding supplier providing cost-efficient nomegestrol acetate, with increasing regulatory approvals in Western markets [5].

Finished Dosage Form Manufacturing

3. Contract Manufacturing Organizations (CMOs)
   Major pharmaceutical companies often outsource DUAVEE’s final formulation, packaging, and distribution to specialized CMOs for scalability and regulatory efficiency. Key players include:
   • Catalent, Inc. (USA): A leader in drug formulation, responsible for manufacturing complex oral hormonal therapies, leveraging advanced capabilities for controlled-release formulations [6].
   • Recipharm (Sweden): Its extensive experience in hormonal product manufacturing makes it a reliable partner for finished DUAVEE tablets, ensuring product quality and regulatory compliance [7].

Distribution and Supply Chain Stakeholders

4. Distribution Networks
   Global distribution relies on authorized distributors, with regional partners responsible for ensuring timely delivery and regulatory adherence. Notable distributors include:
   • McKesson Corporation (USA): A major distributor ensuring supply chain robustness for hormonal drugs in the U.S. market.
   • Sinclair Pharma (UK): Handles European and UK markets, maintaining compliance with regional regulations.

Regulatory and Quality Assurance Agencies
Suppliers must meet the stringent demands of regulatory authorities like the FDA, EMA, and China Food and Drug Administration (CFDA). GMP certification and continued compliance are non-negotiable factors influencing supplier selection.

Supply Chain Risks and Considerations

• Geopolitical Factors: China and India dominate API production; geopolitical tensions could impact raw material supply.
• Regulatory Compliance: Suppliers must maintain certifications to avoid manufacturing delays or market withdrawal.
• Capacity Constraints: High global demand for hormonal therapies necessitates diversified sourcing strategies to mitigate supply shortages.

Emerging Trends in Supplier Dynamics

• Shift toward Regional Manufacturing: To reduce lead times and mitigate geopolitical risks, companies prioritize regional API production.
• Vertical Integration: Some firms are investing in in-house API synthesis to secure supply chains, reducing dependency on external suppliers.
• Sustainable Sourcing Efforts: Increasing emphasis on sustainable and ethically sourced APIs influences supplier selection paradigms.

Conclusion
The intricate supply landscape for DUAVEE encompasses global API manufacturers, contract manufacturers, and distribution channels. Key providers from Europe, Asia, and North America ensure a resilient supply chain, with ongoing geopolitical and regulatory factors influencing strategic planning. Businesses involved in manufacturing or distributing DUAVEE must prioritize supplier qualification, regulatory compliance, and diversification to mitigate risks.

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Key Takeaways

• Diverse API sources: Major suppliers for estradiol and nomegestrol acetate include Siegfried (Germany), IBSA (Italy), and Zhejiang NHU (China).
• Manufacturing partners: Contract manufacturers like Catalent and Recipharm play critical roles in final product formulation and packaging.
• Regulatory vigilance: Maintaining GMP certification and compliance with international standards is essential for uninterrupted supply.
• Supply chain resilience: Dependence on Chinese and Indian APIs underscores the need for diversified sourcing strategies amidst geopolitical tensions.
• Emerging trends: Regional API manufacturing and vertical integration are key strategies for future supply chain stability.

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FAQs

1. Who are the primary global suppliers of estradiol API for DUAVEE?
Major sources include Siegfried AG (Germany), Wockhardt Ltd. (India), and Xianju Pharmaceutical Co., Ltd. (China), each offering varying balances of quality and cost.

2. What are the key considerations when selecting a nomegestrol acetate API supplier?
Regulatory compliance (GMP certification), API purity, cost-effectiveness, and supply capacity are critical factors. IBSA (Italy) and Zhejiang NHU (China) are notable providers.

3. How do manufacturers ensure the quality and regulatory compliance of their API suppliers?
Through audits, GMP certification, ongoing supplier qualification programs, and compliance with regulatory standards enforced by agencies like the FDA and EMA.

4. Are there regional shifts in API sourcing for DUAVEE?
Yes, there's a trend toward regionalizing production to reduce dependency on Chinese and Indian suppliers, emphasizing North American and European manufacturing capabilities.

5. What risks are associated with the current supply chain for DUAVEE?
Risks include geopolitical tensions, supply interruptions from high-demand API markets, regulatory changes, and capacity constraints. Diversification and monitoring are essential mitigation strategies.

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References

[1] Siegfried AG. "API Portfolio." Siegfried Group, 2023.
[2] Xianju Pharmaceutical Co., Ltd. Official Website. 2023.
[3] Wockhardt Ltd. Annual Report. 2022.
[4] IBSA Farmaceutici. Product Quality Standards. 2023.
[5] Zhejiang NHU Co., Ltd. Corporate Overview. 2023.
[6] Catalent. Contract Development and Manufacturing. 2023.
[7] Recipharm. API and Finished Drug Manufacturing Capabilities. 2023.