bazedoxifene acetate; estrogens, conjugated: Pharmaceutical manufacturers, suppliers, and distributors

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical landscape for hormone therapies and selective estrogen receptor modulators (SERMs) is highly regulated, with numerous manufacturers supplying active pharmaceutical ingredients (APIs). Two notable compounds within this sphere are Bazedoxifene Acetate, a SERM primarily used for osteoporosis treatment, and Estrogens, Conjugated, a mixture of esterified estrogens employed chiefly in hormone replacement therapy (HRT). This analysis explores current supplier landscapes, focusing on leading API manufacturers, market dynamics, and procurement considerations relevant to healthcare providers, distributors, and pharmaceutical companies.

Bazedoxifene Acetate: Market Overview

Manufacturers and Suppliers

Bazedoxifene Acetate (BZA) is a third-generation SERM developed by Schering-Plough (now integrated into Merck & Co.) and marketed notably under the brand name Duavee. Its manufacture involves complex synthesis procedures, with only a handful of companies possessing the technical capacity and regulatory approval to produce this API at scale.

Merck & Co.
As the original developer, Merck is a primary supplier of Bazedoxifene Acetate, securing global rights post-acquisition of Schering-Plough’s portfolio. The company supplies APIs directly or through authorized distributors to ensure quality and traceability.
Zhejiang Conba Pharmaceutical Co., Ltd.
A notable Chinese manufacturer with reported API production capabilities for BZA. Despite limited public disclosure, Zhejiang Conba supplies generic versions of bazedoxifene to markets in Asia and emerging regions.
Hubei Jusheng Technology Co., Ltd.
An established Chinese API producer with the capacity to manufacture selective estrogen receptor modulators, including bazedoxifene, compliant with Good Manufacturing Practice (GMP) standards.
Teva Pharmaceutical Industries and Mylan N.V.
These global generics players may source BZA APIs through licensed arrangements or engage third-party manufacturers in markets where patent protections have lapsed or are in process.

Market Dynamics and Approvals

BZA’s niche positioning limits the number of active suppliers to those with advanced synthesis capabilities, strict quality control, and regulatory approvals. The global shortage of high-purity BZA APIs is rare, but regional production limitations can impact supply chains, especially in emerging markets.

Estrogens, Conjugated: Market Overview

Leading Suppliers

"Estrogens, conjugated" refers primarily to conjugated estrogens derived from pregnant mare's urine, with Premarin being the most recognized brand. The API is characterized by a complex mixture of estrogenic substances.

Pfizer Inc. (Wyeth)
Historically, Pfizer has been the dominant supplier of conjugated estrogens and continues to supply the API through licensed manufacturing facilities. Pfizer maintains rigorous quality standards, and its conjugated estrogens are widely used across global markets.
Novartis AG (through NVS in the past)
Although Novartis no longer manufactures conjugated estrogens, it licensed production to other companies; some regions may source APIs from alternate licensed producers.
Major Chinese API manufacturers:
Several companies, such as Zhejiang Jingxin Pharmaceutical Co., Ltd. and Shanghai Zhenghua Biotech Co., Ltd., produce conjugated estrogens for both domestic and export markets, often via fermentation processes and extraction from urine.
Indian Manufacturers:
Companies like Sun Pharma and Lupin have developed conjugated estrogens APIs, aligning with global GMP standards to serve both generics and branded markets.

Synthetic Alternatives

Recent developments see the emergence of synthetic alternatives to natural conjugated estrogens, produced via chemical synthesis by companies such as Thermo Fisher Scientific and Cayman Chemical, primarily serving research and niche pharmaceutical markets.

Supply Chain and Regulatory Considerations

The API supply chain for both BZA and conjugated estrogens is characterized by concentrated production capabilities predominantly in North America, Europe, and select Asian countries. Regulatory approvals (FDA, EMA, PMDA) act as prerequisites for international supply, necessitating manufacturers to maintain compliance with stringent GMP standards.

In addition, patent protections influence supplier options, with patent expirations opening opportunities for generic manufacturers in emerging markets. Consequently, the landscape varies across regions, with local regulatory agencies approving different sources based on safety and quality assessments.

Procurement Insights

Healthcare providers and pharmaceutical companies seeking reliable API sources should prioritize suppliers offering:

Regulatory Certification: GMP compliance, WHO prequalification (for low- and middle-income markets)
Quality Consistency: Batch-to-batch uniformity, high assay purity (>98%)
Traceability: Clear documentation, quality assurance processes
Capacity and Lead Time: Supplier ability to meet demand fluctuations

Establishing partnerships with established suppliers like Pfizer or Merck reduces supply chain risks; however, emerging manufacturers in China and India present cost-effective alternatives, provided they meet international standards.

Conclusion

The supply of Bazedoxifene Acetate and conjugated estrogens is concentrated among a few global and regional manufacturers. Merck remains the primary supplier of BZA API, leveraging its original development rights, while multiple Chinese and Indian manufacturers offer generics and market-specific options. For conjugated estrogens, Pfizer maintains a dominant position, supplemented by regional API producers.

Given the regulatory complexities and quality demands, organizations must meticulously evaluate supplier credentials, compliance history, and production capacity to ensure uninterrupted access to these critical APIs.

Key Takeaways

Limited but Concentrated Supply: Both BZA and conjugated estrogens APIs are supplied predominantly by a select group of global and regional manufacturers, emphasizing the need for rigorous supplier due diligence.
Regulatory Stringency: GMP certification and adherence to international standards are critical for suppliers in this market segment.
Emerging Market Opportunities: Chinese and Indian API manufacturers are expanding offerings, often at lower costs but requiring careful validation of quality and compliance.
Supply Chain Resilience: Diversifying supply sources and establishing long-term partnerships can mitigate risks associated with patent restrictions, regional regulations, and geopolitical factors.
Quality Assurance: High assay purity and consistent batch quality remain non-negotiable parameters when selecting suppliers for APIs used in hormone therapies.

FAQs

1. Who are the main global suppliers of Bazedoxifene Acetate API?
Merck is the principal original supplier, with additional API production capacity from Chinese manufacturers like Zhejiang Conba Pharmaceutical and Hubei Jusheng Technology, primarily serving regional markets.

2. Can I source conjugated estrogens API from suppliers outside the US and Europe?
Yes. Several Chinese and Indian manufacturers produce conjugated estrogens APIs. Procurement from these sources requires verification of quality standards, GMP certification, and regulatory approval in target markets.

3. Is there a significant difference in API quality between branded and generic suppliers?
Potentially, yes. Established brands like Pfizer and Merck maintain strict quality controls aligned with global standards, whereas generics from reputable manufacturers can match quality if they hold proper certifications, but due diligence is necessary.

4. Are there synthetic alternatives to conjugated estrogens in development?
Yes. Synthetic estrogen compounds offering similar therapeutic profiles are under research and development, aiming to improve stability, purity, and manufacturing efficiency.

5. How do regional regulations impact API supply for these drugs?
Regulatory approvals influence which suppliers can legally export APIs to specific markets. Changes in policies, patent statuses, and compliance requirements may expand or restrict supplier options over time.

Sources

[1] Merck & Co. Official Product and API Information, 2022.
[2] Chinese Pharmaceutical Industry Reports, 2021.
[3] U.S. Food and Drug Administration (FDA) Database.
[4] European Medicines Agency (EMA) Documentation, 2022.
[5] Market Analysis Reports on Hormone API Manufacturing, 2022.

Suppliers and packagers for generic pharmaceutical drug: bazedoxifene acetate; estrogens, conjugated