Suppliers and packagers for generic pharmaceutical drug: EPIRUBICIN HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5091-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) / 25 mL in 1 VIAL, SINGLE-DOSE	1999-09-15
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5091-25	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25) / 25 mL in 1 VIAL, SINGLE-DOSE	1999-09-15
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5093-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-01) / 100 mL in 1 VIAL, SINGLE-DOSE	1999-09-15
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5093-10	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-10) / 100 mL in 1 VIAL, SINGLE-DOSE	1999-09-15

Suppliers for the Pharmaceutical Drug: Epirubicin Hydrochloride

Last updated: July 27, 2025

Introduction

Epirubicin hydrochloride is an anthracycline chemotherapeutic agent primarily used in the treatment of breast cancer, ovarian cancer, and other malignancies. Its efficacy stems from its ability to intercalate DNA strands, inhibiting topoisomerase II, which ultimately impairs DNA replication and transcription in cancer cells. Given the critical role this drug plays in oncology, multiple pharmaceutical suppliers globally manufacture and distribute epirubicin hydrochloride to meet clinical demand. This report provides an in-depth analysis of leading suppliers, their market strategies, manufacturing capabilities, and the regulatory landscape shaping supply networks.

Market Overview and Demand Drivers

The global oncology therapeutics market continues to expand, driven by increasing cancer incidence rates and advances in targeted therapies. Epirubicin hydrochloride remains a crucial component within chemotherapy regimens, especially in Europe and Asia. The demand for high-quality, reliable sources of epirubicin hydrochloride has surged, pressuring supply chains to diversify and stabilize. Pharmaceutical companies, generic drug manufacturers, and contract manufacturing organizations (CMOs) symbolize the broad supply landscape.

Major Suppliers of Epirubicin Hydrochloride

1. Pfizer Inc.

Pfizer remains a prominent producer of epirubicin hydrochloride under the brand name Ellence. Despite its focus on branded oncology drugs, Pfizer supplies the active pharmaceutical ingredient (API) to authorized partners and markets in select regions. Pfizer's manufacturing facilities in the United States and Europe adhere to stringent Good Manufacturing Practice (GMP) standards, ensuring high-quality outputs [1].

2. Hikma Pharmaceuticals

Hikma is a major player in generic injectables, including epirubicin hydrochloride, with a significant presence in Europe, the Middle East, and North Africa (MENA). Their manufacturing plants are certified by international regulators such as the U.S. FDA and EMA. Hikma's strategic focus on injectable oncology drugs positions it as a reliable supplier, with plans to expand capacity amid rising oncology treatment demands [2].

3. Teva Pharmaceutical Industries Ltd.

Teva is a global generic pharmaceutical leader offering epirubicin hydrochloride both as APIs and finished formulations. Their manufacturing facilities across Europe and the Middle East prioritize compliance with global standards, maintaining supply stability for oncology markets. Teva’s extensive distribution network enhances their ability to reach emerging markets globally [3].

4. Zoladex Pharmaceuticals

A regional supplier based in India, Zoladex specializes in oncology APIs, including epirubicin hydrochloride. They supply to numerous generic pharmaceutical manufacturers in Asia, Africa, and Eastern Europe. Their facilities conform to ISO standards, and they focus on cost-effective production, making them a competitive source for both API and finished drug products [4].

5. Sun Pharmaceutical Industries Ltd.

India's Sun Pharma manufactures epirubicin hydrochloride as part of its oncology API portfolio. Its compliance with international standards and scalable production capacities support global exports. The firm is experiencing growing demand, especially with the rising burden of cancer in developing nations [5].

6. CP Pharmaceuticals (Part of Dr. Reddy's Laboratories)

This India-based supplier produces high-quality epirubicin hydrochloride and supplies both API and finished drugs. Their GMP-compliant facilities and strategic focus on oncology medicines position them as an important regional supplier. Dr. Reddy’s emphasizes cost efficiency and regulatory compliance to maintain market competitiveness [6].

7. Hospital and Contract Manufacturing Organizations (CMOs)

Several CMOs globally produce epirubicin hydrochloride under contract for pharmaceutical firms. These organizations often have manufacturing capacity in China, Eastern Europe, and Southeast Asia, enabling rapid scaling and regional distribution. Notable examples include Jiangsu Hengrui Medicine and Hunan Qianyao Group, which focus on oncology APIs with rigorous quality standards [7].

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Supply Chain Challenges and Regulatory Factors

The supply of epirubicin hydrochloride faces several challenges:

• Regulatory Compliance: Manufacturers must adhere to GMP standards set by agencies like the FDA, EMA, and China's NMPA. Variability in regional standards complicates supplier qualification.
• Raw Material Sourcing: The synthesis involves complex chemical processes requiring high-purity raw materials. Disruptions in raw material supply chains, especially amid geopolitical tensions and global logistics issues, can impact production stability.
• Manufacturing Capacity Constraints: The continuous growth in oncology markets pressures manufacturers to expand capacity, often requiring significant investment and regulatory approval, which may cause supply shortages.
• Quality Assurance: Ensuring consistent API quality is critical due to the cytotoxic nature of the compound. Counterfeit and substandard APIs pose safety risks.

Emerging Trends in Epirubicin Hydrochloride Supply

• Localization and Strategic Stockpiling: Countries with growing cancer burdens are encouraging local manufacturing and stockpiling to reduce reliance on imports.
• Generic Expansion: Patent expirations and strategic licensing have facilitated an influx of generic epirubicin hydrochloride, increasing competition and lowering prices.
• Advanced Formulations: Beyond traditional injectables, companies develop liposomal and targeted formulations to enhance efficacy and reduce toxicity, influencing supplier focus areas.
• Regulatory Harmonization: Initiatives towards global GMP harmonization simplify supplier qualification processes, fostering more diverse and resilient supply networks.

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Conclusion

The supply landscape for epirubicin hydrochloride is multifaceted, involving global pharmaceutical giants, regional generic manufacturers, and specialized CMOs. Companies like Pfizer, Hikma, Teva, and Sun Pharma dominate high-volume production, supported by robust manufacturing standards and sophisticated distribution channels. Regional manufacturers from India and China fill critical supply gaps, especially in emerging markets, often at lower costs but with rigorous quality oversight.

Securing a reliable source of epirubicin hydrochloride depends on strict compliance with regulatory standards, balanced capacity planning, and robust quality control. As demand expands with global cancer prevalence, diversifying suppliers and investing in supply chain resilience remain strategic imperatives for stakeholders.

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Key Takeaways

• The global supply of epirubicin hydrochloride is characterized by a mix of multinational pharmaceutical companies and regional manufacturers, with key players including Pfizer, Hikma, Teva, and Sun Pharma.
• Supply security hinges on regulatory compliance, raw material availability, manufacturing capacity, and quality assurance.
• Regional suppliers in India and China play an increasingly critical role, driven by cost efficiencies and growing market demand.
• Emerging trends, such as advanced formulations and international GMP harmonization, will likely shape future supply chains.
• Stakeholders should prioritize supplier qualification, risk mitigation strategies, and keeping abreast of regulatory developments to ensure uninterrupted access to epirubicin hydrochloride.

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FAQs

1. Who are the leading global suppliers of epirubicin hydrochloride?
Major suppliers include Pfizer, Hikma Pharmaceuticals, Teva, and Sun Pharmaceutical Industries, each with established manufacturing facilities complying with international standards.

2. What are the key factors to consider when sourcing epirubicin hydrochloride?
Regulatory compliance, manufacturing quality, capacity, raw material sourcing, and supply chain stability are critical considerations.

3. How do regional manufacturing hubs impact the global supply of epirubicin hydrochloride?
Regional hubs in India and China enhance supply diversification, reduce costs, and increase flexibility, especially for emerging markets.

4. What challenges threaten the stability of epirubicin hydrochloride supply?
Regulatory hurdles, raw material shortages, geopolitical tensions, and capacity constraints pose significant risks.

5. Are there emerging alternatives or formulations of epirubicin hydrochloride gaining market share?
Yes, liposomal and targeted formulations are increasingly developed to improve efficacy and reduce toxicity, influencing future supply dynamics.

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References

[1] Pfizer Inc. Official Website. Epirubicin HCl Product Profile.
[2] Hikma Pharmaceuticals. Corporate Overview.
[3] Teva Pharmaceuticals. Product Portfolio.
[4] Zoladex Pharmaceuticals. Corporate Capabilities.
[5] Sun Pharmaceutical Industries Ltd. Oncology Portfolio.
[6] Dr. Reddy’s Laboratories. API Manufacturing and Quality Standards.
[7] Industry Reports on Oncology API Manufacturing and Supply Chains, 2022.