Suppliers and packagers for SOLTAMOX

SOLTAMOX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807	NDA	Mayne Pharma	51862-682-00	1 CONTAINER in 1 CARTON (51862-682-00) / 150 mL in 1 CONTAINER	2021-06-18
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807	NDA	Mayne Pharma	51862-682-01	1 CONTAINER in 1 CARTON (51862-682-01) / 150 mL in 1 CONTAINER	2021-06-18

Suppliers for the Pharmaceutical Drug: Soltamox

Last updated: August 1, 2025

Introduction

Soltamox, the brand name for tamoxifen citrate, is a widely prescribed selective estrogen receptor modulator (SERM). It primarily treats hormone receptor-positive breast cancer in both adjuvant and metastatic settings. As a critical medication in oncology, its supply chain is integral to global cancer care. Understanding the key suppliers, manufacturing dynamics, and market players is essential for stakeholders, including healthcare providers, pharmaceutical companies, and regulatory agencies.

Overview of Soltamox and Its Components

Soltamox consists of tamoxifen citrate, an active compound developed in the 1960s and approved by the FDA in 1977. It operates by binding to estrogen receptors, inhibiting estrogen's proliferative effects on breast tissue. Its manufacturing involves sourcing active pharmaceutical ingredients (APIs), excipients, and specialist packaging. The supply chain's robustness depends heavily on API production, quality control, and distribution channels.

Major Suppliers of Tamoxifen Citrate API

The primary stage of Soltamox’s supply chain hinges on sourcing high-quality tamoxifen citrate API. Several multinational pharmaceutical APIs (API) manufacturers produce tamoxifen citrate, including:

1. Hetero Labs Limited (India)
   Hetero is a leading generic pharmaceutical and API manufacturer, supplying tamoxifen citrate APIs to global markets. Its facilities are validated through stringent international standards, including WHO-GMP, indicating high quality and compliance.

2. Zhejiang Kangtai Pharmaceutical Co., Ltd. (China)
   Kangtai specializes in manufacturing APIs for oncology drugs, including tamoxifen citrate. Their production adheres to international GMP standards, with export capabilities worldwide.

3. Jubilant Life Sciences (India)
   Jubilant produces APIs for various therapeutic classes, including hormonal agents like tamoxifen citrate. Their strategic focus on quality and regulatory compliance makes them a significant API supplier.

4. Hunan Dongting Pharmaceutical Co., Ltd. (China)
   This firm supplies tamoxifen citrate API mainly for domestic Chinese markets but has expanded exports due to growing global demand.

5. Dr. Reddy’s Laboratories (India)
   Dr. Reddy's manufactures both finished dosage forms and APIs, with api manufacturing capacity for tamoxifen citrate serving several pharmaceutical companies globally.

Manufacturers of Finished Soltamox Products

While the original Soltamox is developed by AstraZeneca, numerous generic manufacturers produce equivalent formulations under various brand names or as unbranded generics. Notable firms include:

• Teva Pharmaceuticals
• Mylan (now part of Viatris)
• Sandoz (Novartis)
• Hikma Pharmaceuticals
• Sun Pharmaceutical Industries

These manufacturers generally source tamoxifen citrate APIs from the aforementioned suppliers or other regional API producers, then formulate, package, and distribute the finished product globally.

Distribution Channels and Key Markets

Soltamox is distributed via multiple channels, including:

• Hospital and retail pharmacies in North America, Europe, Asia, and emerging markets
• Direct supply agreements with healthcare providers and cancer centers
• Government procurement programs in countries with publicly funded healthcare systems

Major pharmaceutical wholesalers and distributors play a crucial role in ensuring stable supply, especially during critical periods such as during disruption events or pandemics.

Regulatory Considerations in Supplier Selection

Regulatory compliance significantly influences supplier choices. Suppliers with GMP certifications recognized by agencies such as the FDA, EMA, PMDA (Japan), or evaluating bodies like WHO prequalification are preferred. Quality assurance in APIs and finished formulations reduces manufacturing risks and ensures therapeutic efficacy.

Emerging Trends and Challenges in the Supply Chain

• API manufacturing concentration: The supply chain for tamoxifen citrate APIs is concentrated among a few large manufacturers in India and China. This concentration risks supply disruptions due to geopolitical tensions, regulatory changes, or production issues.

• Quality standards divergence: Variability in API quality and regulatory acceptance across regions can influence supplier selection.

• Patent expiries and generics proliferation: With patent expiry, the market has seen an influx of generics, amplifying competition but also fragmenting the supply chain.

• Supply chain resilience: Recent global disruptions underscore the need for diversified sourcing and supply chain redundancy to mitigate shortages.

Key Players and Competitive Landscape

The landscape features a mix of large multinational corporations with integrated supply chains and regional manufacturers focusing on specific markets. AstraZeneca, as the originator of Tamoxifen, held a significant share historically, but market dynamics have shifted toward generic manufacturers. Their capabilities in API manufacturing and formulation production determine their market presence.

Conclusion

The supply of Soltamox hinges critically on the availability and quality of tamoxifen citrate APIs produced mainly by Indian and Chinese manufacturers. Established pharmaceutical firms—such as Hetero, Jubilant, Zhejiang Kangtai, and Dr. Reddy’s—are central to the API ecosystem, while global generics players distribute finished Soltamox medication worldwide. The healthcare industry must monitor market concentration, regulatory standards, and geopolitical factors to maintain a stable supply chain for this essential oncology therapy.

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Key Takeaways

• Dominant API suppliers include Hetero Labs, Jubilant, Zhejiang Kangtai, and Dr. Reddy’s, predominantly based in India and China.
• Manufacturers of finished Soltamox are primarily global generic firms, including Teva, Mylan, Sun Pharma, and Hikma.
• Regulatory standards such as GMP accreditation are critical in supplier selection, ensuring quality and compliance.
• Supply chain risks stem from market concentration in API production, geopolitical tensions, and global disruptions, emphasizing the need for diversification.
• Stakeholders must actively monitor regulatory landscapes, supplier quality, and geopolitical developments to ensure uninterrupted access to Soltamox.

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FAQs

1. What are the main sources of tamoxifen citrate API for Soltamox?
The primary sources are manufacturers like Hetero Labs (India), Jubilant Life Sciences (India), Zhejiang Kangtai (China), and Dr. Reddy’s Laboratories (India). These companies produce the API in compliance with GMP standards for global distribution.

2. Are there any risks associated with the API supply chain for Soltamox?
Yes, the API supply is concentrated among a few manufacturers primarily in India and China, posing risks related to geopolitical tensions, regulatory changes, and manufacturing disruptions, which could lead to shortages.

3. How do regulatory standards impact Soltamox suppliers?
Suppliers with GMP certification recognized by major regulatory agencies (FDA, EMA, WHO) ensure higher quality and regulatory acceptance, reducing the risk of product recalls or market access issues.

4. Which companies manufacture finished Soltamox products?
Major generic pharmaceutical companies such as Teva, Mylan (Viatris), Sandoz, Hikma, and Sun Pharma produce finished formulations distributed worldwide, often sourcing APIs from various suppliers.

5. How can stakeholders ensure a stable supply of Soltamox?
Diversifying API sourcing, maintaining regulatory compliance, monitoring geopolitical developments, and establishing long-term supply agreements are key strategies to ensuring continuous availability of Soltamox.

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Sources

[1] World Health Organization, "WHO Prequalification of Medicines Program," 2022.
[2] U.S. Food and Drug Administration, "Approved Drug Products," 2023.
[3] Industry reports on Pharmaceutical APIs, IQVIA, 2022.
[4] Company websites: Hetero Labs, Jubilant Life Sciences, Zhejiang Kangtai, Dr. Reddy’s.
[5] Market analyses from GlobalData and Pharma Intelligence, 2022.