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

Epirubicin Hydrochloride API Suppliers

Last updated: February 19, 2026

This analysis identifies key suppliers of Epirubicin Hydrochloride Active Pharmaceutical Ingredient (API), detailing their manufacturing capabilities, regulatory compliance, and product specifications. The global market for Epirubicin Hydrochloride API is characterized by a limited number of specialized manufacturers, with significant production concentrated in India and China.

What are the primary global suppliers of Epirubicin Hydrochloride API?

The global supply chain for Epirubicin Hydrochloride API is primarily served by a select group of manufacturers, with a notable concentration in Asia. These entities possess the requisite manufacturing infrastructure and regulatory accreditations to produce API meeting stringent pharmaceutical standards.

• Huihong Pharmaceutical Co., Ltd. (China): Huihong Pharmaceutical is a significant producer of cytotoxic APIs, including Epirubicin Hydrochloride. The company operates under Good Manufacturing Practices (GMP) and holds various international certifications. Their product is typically supplied in powder form.
• Shandong Xinhua Pharmaceutical Co., Ltd. (China): Xinhua Pharmaceutical is a well-established pharmaceutical manufacturer with a broad portfolio of APIs. They are a known supplier of Epirubicin Hydrochloride, adhering to international quality standards.
• Teva Pharmaceutical Industries Ltd. (Israel): While Teva is a major finished dosage form manufacturer, they also have API manufacturing capabilities that may include Epirubicin Hydrochloride for captive use or select external sales. Teva operates under stringent FDA and EMA compliant GMP.
• Sun Pharmaceutical Industries Ltd. (India): Sun Pharma, one of the largest generic pharmaceutical companies globally, is a potential supplier of Epirubicin Hydrochloride API through its API manufacturing divisions. Their facilities are subject to regular inspections by regulatory bodies including the US FDA and EMA.
• Dr. Reddy's Laboratories (India): Similar to Sun Pharma, Dr. Reddy's Laboratories is a prominent Indian API producer with the capacity to manufacture complex oncology APIs. Their compliance with international GMP standards is a key aspect of their supply chain.

What are the typical specifications for Epirubicin Hydrochloride API?

Epirubicin Hydrochloride API is manufactured to meet pharmacopoeial standards, ensuring its suitability for pharmaceutical formulations. Key specifications include purity, assay, and physical characteristics.

Parameter	Specification	Reference Standard
Appearance	Red crystalline powder	Pharmacopoeial Monograph
Identification	Conforms to specific spectroscopic and chromatographic tests	Pharmacopoeial Monograph
Assay (on anhydrous basis)	98.0% – 102.0%	USP, EP, JP, IP
Water Content	Not more than 4.0%	USP, EP, JP, IP (Karl Fischer Titration)
Related Substances	Individual unspecified impurities not more than 0.10%	USP, EP, JP, IP (HPLC analysis)
	Total impurities not more than 1.0%	USP, EP, JP, IP (HPLC analysis)
Heavy Metals	Not more than 10 ppm	USP, EP, JP, IP
Residue on Ignition	Not more than 0.1%	USP, EP, JP, IP
pH (1% solution)	4.0 – 5.5	USP, EP, JP, IP
Specific Rotation	Within specified range	USP, EP, JP, IP
Microbial Limits	Meets specified limits for total aerobic microbial count and absence of specified objectionable microorganisms	USP, EP, JP, IP

Source: Typical specifications derived from pharmacopoeial monographs (USP, EP, JP, IP) and supplier data.

What regulatory compliance is required for Epirubicin Hydrochloride API suppliers?

Suppliers of Epirubicin Hydrochloride API must adhere to stringent regulatory requirements to ensure product quality, safety, and efficacy. This includes Good Manufacturing Practices (GMP) and dossier submissions.

• Good Manufacturing Practices (GMP): Manufacturers must operate under GMP guidelines as mandated by major regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Facilities are subject to periodic audits and inspections.
• Drug Master Files (DMFs): API suppliers typically file DMFs with regulatory authorities (e.g., FDA in the US, ASMF in Europe). These confidential documents contain detailed information about the manufacturing process, facilities, quality control, and stability of the API. Pharmaceutical companies reference these DMFs in their drug product applications.
• Certificates of Suitability (CEP): In Europe, manufacturers may obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM). A CEP demonstrates that the API complies with the relevant European Pharmacopoeia monograph.
• ISO Certifications: While not directly pharmaceutical regulatory requirements, ISO 9001 (Quality Management) and ISO 14001 (Environmental Management) certifications indicate a commitment to standardized operational processes and environmental responsibility.
• REACH Compliance: For APIs exported to the European Union, compliance with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation is necessary for certain aspects of chemical handling and safety data.

What are the key considerations for sourcing Epirubicin Hydrochloride API?

Sourcing Epirubicin Hydrochloride API requires a comprehensive evaluation of supplier capabilities, regulatory standing, and supply chain reliability.

• Quality Control and Assurance: Assess the supplier's quality management system. This includes reviewing their in-house testing procedures, validation of analytical methods, and batch-to-batch consistency data.
• Regulatory Filings: Confirm the status of the supplier's DMF or ASMF and their acceptance by the target regulatory authorities in your market. Audit reports from regulatory agencies should be reviewed if available.
• Manufacturing Capacity and Lead Times: Evaluate the supplier's production capacity to ensure it can meet projected demand. Understand their typical lead times for API production and delivery.
• Supply Chain Security and Auditing: Conduct or request supplier audits to verify GMP compliance and assess their supply chain robustness. Understand their raw material sourcing and risk mitigation strategies.
• Intellectual Property and Patents: Investigate existing patents covering the manufacturing process or specific forms of Epirubicin Hydrochloride to avoid infringement.
• Cost and Commercial Terms: Negotiate pricing based on volume, quality specifications, and payment terms. Analyze the total cost of ownership, including freight, duties, and quality assurance expenses.
• Stability Data: Review comprehensive stability studies to understand the API's shelf life under recommended storage conditions and its behavior during transportation.

What are the manufacturing challenges for Epirubicin Hydrochloride API?

The synthesis of Epirubicin Hydrochloride is a complex chemical process involving multiple steps and requiring specialized handling due to its cytotoxic nature.

• Chiral Synthesis: Epirubicin is an epimer of doxorubicin. The stereoselective synthesis to achieve the correct configuration at the C-4' position is critical and technically demanding.
• Handling of Cytotoxic Materials: Manufacturing facilities must employ strict containment measures and personal protective equipment to safeguard personnel and prevent cross-contamination. Waste disposal protocols for cytotoxic materials are also highly regulated.
• Purity and Impurity Control: Achieving high purity and controlling related substances, including process-related impurities and degradation products, requires sophisticated purification techniques and rigorous analytical testing. Specific impurities can impact the drug's safety and efficacy.
• Scale-Up Challenges: Transitioning from laboratory-scale synthesis to commercial-scale production can present significant challenges in maintaining yield, purity, and stereochemical integrity.
• Regulatory Scrutiny: As an oncology drug, Epirubicin Hydrochloride API is subject to intense regulatory scrutiny. Manufacturers must maintain meticulous documentation and compliance with evolving GMP standards.
• Raw Material Sourcing: The availability and consistent quality of key starting materials and intermediates are crucial. Sourcing these specialized chemicals can sometimes be a bottleneck.

What is the market landscape for Epirubicin Hydrochloride API?

The market for Epirubicin Hydrochloride API is driven by its use in chemotherapy for various cancers. The demand is influenced by cancer incidence rates, treatment guidelines, and the availability of biosimil alternatives.

• Oncology Market Growth: The global oncology market continues to grow, leading to sustained demand for cytotoxic APIs like Epirubicin Hydrochloride.
• Generic Competition: The expiration of primary patents for Epirubicin Hydrochloride has led to a robust generic market, increasing the demand for cost-effective API from multiple suppliers.
• Geographic Production Concentration: A significant portion of Epirubicin Hydrochloride API production is located in India and China, which offer competitive manufacturing costs. This creates reliance on these regions for global supply.
• Regulatory Hurdles: The high barrier to entry due to stringent regulatory requirements limits the number of new API manufacturers entering the market.
• Supply Chain Vulnerability: Reliance on a few key suppliers and geographic regions can expose the market to supply chain disruptions due to geopolitical events, natural disasters, or regulatory changes.
• Emerging Markets: Growing healthcare infrastructure and increasing access to cancer treatment in emerging markets are expected to contribute to future demand.

Key Takeaways

The global supply of Epirubicin Hydrochloride API is concentrated among a limited number of manufacturers, primarily in China and India. Key suppliers include Huihong Pharmaceutical, Shandong Xinhua Pharmaceutical, Teva Pharmaceutical, Sun Pharmaceutical Industries, and Dr. Reddy's Laboratories. API must meet rigorous pharmacopoeial specifications regarding purity, assay, and impurity profiles, with stringent adherence to GMP and regulatory filing requirements (DMFs, CEPs) being paramount for market access. Sourcing decisions must prioritize quality control, regulatory compliance, manufacturing capacity, supply chain security, and intellectual property considerations. Manufacturing challenges include stereoselective synthesis, safe handling of cytotoxic materials, achieving high purity, and successful scale-up. The market is driven by oncology demand, generic competition, and is characterized by a concentration of production in Asia, underscoring the importance of supply chain risk assessment.

Frequently Asked Questions

1. What is the typical shelf life of Epirubicin Hydrochloride API?

Typical shelf life ranges from 24 to 36 months when stored under recommended conditions (e.g., protected from light, controlled temperature). Specific stability data should be obtained from the manufacturer.

2. Are there any significant patent expiries impacting Epirubicin Hydrochloride API supply?

The primary patents for Epirubicin Hydrochloride have long since expired, which has facilitated the entry of generic API manufacturers and increased competition. However, patents for specific manufacturing processes or novel formulations may still exist.

3. What are the primary analytical techniques used for Epirubicin Hydrochloride API quality control?

High-Performance Liquid Chromatography (HPLC) is extensively used for assay determination and related substances testing. Spectroscopic methods like UV-Vis and Infrared (IR) spectroscopy, along with Karl Fischer titration for water content, are also standard.

4. What are the risks associated with relying on a single supplier for Epirubicin Hydrochloride API?

Reliance on a single supplier increases vulnerability to supply chain disruptions (e.g., manufacturing issues, regulatory actions, geopolitical events), price volatility, and limited negotiation power.

5. How does the cytotoxic nature of Epirubicin Hydrochloride impact its manufacturing and supply chain?

The cytotoxic nature necessitates specialized containment facilities, strict personal protective equipment protocols, rigorous waste management, and controlled transportation to prevent environmental contamination and ensure worker safety, adding complexity and cost to manufacturing and logistics.

Citations

[1] United States Pharmacopeia. (2023). USP: Epirubicin Hydrochloride. United States Pharmacopeial Convention. [2] European Pharmacopoeia. (2023). Ph. Eur.: Epirubicin Hydrochloride. European Directorate for the Quality of Medicines & HealthCare. [3] Huihong Pharmaceutical Co., Ltd. Product Data Sheets and Regulatory Information. (Accessed 2023). [4] Shandong Xinhua Pharmaceutical Co., Ltd. Product Catalog and Regulatory Compliance Information. (Accessed 2023). [5] Teva Pharmaceutical Industries Ltd. Corporate Reports and API Manufacturing Information. (Accessed 2023). [6] Sun Pharmaceutical Industries Ltd. Annual Reports and API Business Unit Information. (Accessed 2023). [7] Dr. Reddy's Laboratories Ltd. Investor Presentations and API Manufacturing Capabilities. (Accessed 2023). [8] Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from https://www.fda.gov/ [9] European Medicines Agency. (n.d.). Guidance Documents. Retrieved from https://www.ema.europa.eu/