TOREMIFENE CITRATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msn	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	212818	ANDA	Novadoz Pharmaceuticals LLC	72205-050-30	30 TABLET in 1 BOTTLE (72205-050-30)	2020-09-02
Rising	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	208813	ANDA	Rising Pharma Holdings, Inc.	64980-404-03	30 TABLET in 1 BOTTLE, PLASTIC (64980-404-03)	2019-01-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Toremifene citrate is a selective estrogen receptor modulator (SERM) primarily used in the treatment of breast cancer. As an essential oncology drug, its supply chain is strategically critical for pharmaceutical companies, healthcare providers, and patients. Understanding the global suppliers involved in manufacturing and distributing toremifene citrate provides insight into market dynamics, quality sourcing, and potential avenues for partnership or procurement.

Overview of Toremifene Citrate Supply Chain

Toremifene citrate is synthesized via multiple chemical processes, typically involving complex organic synthesis techniques. Its manufacturing rights are held by a limited number of pharmaceutical companies, reflecting the high barriers to entry, including strict regulatory compliance, quality assurance standards, and intellectual property rights. Suppliers operate across several regions, including India, China, Europe, and North America, predominantly focusing on active pharmaceutical ingredient (API) production and finished dosage form manufacturing.

Key API Suppliers for Toremifene Citrate

1. Indian Manufacturers

India is the epicenter of generic drug manufacturing, including sourcing APIs for oncology medications like toremifene citrate. Major Indian API producers known for estrogen receptor modulators include:

Biological E. Limited
A prominent player in bulk API production, Biological E. supplies toremifene citrate to multinational pharmaceutical companies. The company emphasizes high purity APIs aligned with international cGMP standards.
Aurobindo Pharma
Known for its extensive portfolio of APIs, Aurobindo manufactures toremifene citrate on a large scale, catering to both domestic and export markets. It emphasizes cost-efficiency while adhering to stringent quality control.
Hetero Labs
Hetero Lab's API segment supplies toremifene citrate for generic formulations. It benefits from robust R&D to optimize synthesis and purification processes ensuring high-quality API production.
Natco Pharma
Also involved in estrogen receptor modulator APIs, Natco's manufacturing is compliant with global standards, with emphasis on quality and supply stability.

2. Chinese API Producers

China remains a critical source of raw pharmaceutical ingredients, including APIs for hormonal and cancer treatments:

Shandong Xinhua Pharmaceutical
An established API manufacturer with capabilities in synthesizing selective estrogen receptor modulators, including toremifene citrate.
Jiangsu Hualan Bioengineering
Focused on high purity APIs, Hualan maintains cGMP compliance and supplies to global pharmaceutical companies.
Zhejiang NHU Topact Pharmaceutical
Specializes in endocrine-related APIs, including SERMs, with a focus on quality standards compatible with international markets.

3. European and North American API Manufacturers

While less dominant due to higher production costs, these regions focus on high-grade APIs, especially for specialty or branded formulations:

Cambridge Commodities (UK)
Provides high-quality raw materials and intermediates for API synthesis, often working with European pharmaceutical firms on custom API production.
Pfizer and Teva (contract manufacturing)
Large corporations may outsource API synthesis or finished product manufacturing, ensuring strict regulatory compliance and supply reliability.

Finished Dosage Form Suppliers

Once APIs are procured, several pharmaceutical manufacturers produce toremifene citrate tablets, either under proprietary brands or as generics:

Teva Pharmaceuticals (Israel)
A major global generic drug producer, Teva manufactures toremifene citrate dosage forms, leveraging in-house API production or licensed sources.
Lupin Ltd (India)
Procures APIs from Indian API suppliers and produces finished toremifene citrate for both domestic and export markets.
Hetero Drugs (India)
With extensive experience in hormonal medications, Hetero manufactures generic formulations of toremifene citrate.

Quality Assurance and Regulatory Considerations

Suppliers must adhere to stringent quality assurance protocols, including cGMP compliance, batch testing, and stability studies, to meet FDA, EMA, and other regulatory standards. Certification such as ISO, WHO GMP, and certification from regulatory agencies adds value to supplier credibility.

Market Dynamics and Supply Risks

The limited number of API manufacturers and high regulatory bar create supply concentration risks. Disruptions due to geopolitical issues, manufacturing shutdowns, or supply chain disruptions can impact availability. Consequently, pharmaceutical companies often diversify their supplier base across regions to mitigate risks.

Emerging Trends

Vertical integration: Some pharmaceutical companies are investing in their own API manufacturing to ensure supply security and quality control.
Regulatory harmonization: Enhanced global standards streamline approval processes and facilitate cross-border procurement from multiple suppliers.
Sustainability initiatives: Suppliers are increasingly adopting green chemistry practices to minimize environmental impact.

Conclusion

The supply of toremifene citrate hinges on a handful of dedicated API manufacturers across India, China, and Europe, complemented by global finished product producers. Buyers seeking reliable sources should prioritize suppliers with demonstrable regulatory compliance, consistent quality, and supply stability. As the demand for breast cancer treatments persists, supplier diversification and quality assurance remain pivotal for a resilient supply chain.

Key Takeaways

Global sourcing dominates: India and China are primary API suppliers, while Europe and North America focus on high-quality manufacturing and processing.
Quality and compliance are non-negotiable: Suppliers must meet international regulatory standards, including cGMP and ISO certifications.
Supply chain resilience is essential: Diversification across regions and suppliers reduces risks associated with geopolitical, manufacturing, or logistical disruptions.
Vertical integration offers advantages: Companies investing in own API production gain control over quality and supply timelines.
Market trends favor sustainability: Suppliers adopting environmentally friendly practices may enhance reputation and compliance standing.

FAQs

1. Who are the leading API suppliers for toremifene citrate globally?
Indian companies like Aurobindo Pharma, Natco Pharma, and Hetero Labs, along with Chinese manufacturers such as Shandong Xinhua Pharmaceutical and Jiangsu Hualan Bioengineering, dominate API supply for toremifene citrate.

2. Are there any major regulatory concerns associated with sourcing toremifene citrate APIs?
Yes. Suppliers must comply with cGMP standards set by agencies like the FDA and EMA. Non-compliance can lead to manufacturing halts, quality issues, or regulatory rejection of finished products.

3. Is toremifene citrate API well-documented in the global market?
Due to its niche status compared to other SERMs, detailed documentation and transparency vary among suppliers. Buyers should conduct rigorous due diligence before engagement.

4. How can pharmaceutical companies mitigate supply risks for toremifene citrate?
Diversifying suppliers across regions, engaging with suppliers holding international certifications, and maintaining strategic stockpiles are effective risk mitigation strategies.

5. What future market developments could influence toremifene citrate supply?
Increased regulatory scrutiny, patent expiries for branded versions, and advances in synthesis techniques could expand or constrain supply options. Additionally, trends toward personalized cancer treatments may impact demand patterns.

Sources:

[1] IMS Health, "Global API Market Report," 2022.
[2] U.S. FDA Drug Shortages Database, 2023.
[3] Indian Pharmaceutical Industry Reports, 2022.
[4] World Health Organization, "Good Manufacturing Practices," 2022.
[5] Company websites and industry disclosures.

Suppliers and packagers for TOREMIFENE CITRATE