Bulk Pharmaceutical API Sources for EPIRUBICIN HYDROCHLORIDE

Bulk Pharmaceutical API Sources for EPIRUBICIN HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246559
NovoSeek		65348
MolPort		MolPort-003-666-844
ABI Chem		AC1L233G

Bulk Active Pharmaceutical Ingredient (API) Sources for: EPIRUBICIN HYDROCHLORIDE

Last updated: July 28, 2025

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Introduction

Epirubicin Hydrochloride is a widely utilized anthracycline antibiotic in chemotherapy, primarily for breast cancer, gastric cancer, and other solid tumors. Its efficacy depends heavily on reliable, high-quality bulk API sourcing. As the pharmaceutical industry emphasizes stringent quality standards, understanding the landscape of API suppliers for epirubicin hydrochloride is essential for pharmaceutical manufacturers, distributors, and healthcare providers.

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Overview of Epirubicin Hydrochloride

Epirubicin hydrochloride is a synthetic anthracycline, modeled after doxorubicin but with a modified configuration that mitigates some cardiotoxic effects. Due to its cytotoxic potency, it necessitates sourcing from reputable manufacturing facilities compliant with international quality standards such as cGMP, ISO, and WHO-GMP.

The global demand for epirubicin hydrochloride hinges on its pharmaceutical applications, with major markets in North America, Europe, and Asia. The API supply chain is concentrated among selected manufacturers with robust R&D capabilities and regulatory track records, underscoring the importance of vetting suppliers thoroughly.

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Key API Suppliers for Epirubicin Hydrochloride

1. Pharmaceutica Ltd. (China)

Pharmaceutica Ltd. is among the leading Chinese API manufacturers specializing in anthracycline derivatives, including epirubicin hydrochloride. The company boasts ISO 9001, GMP, and WHO-GMP certifications, ensuring compliance with international quality standards.

Strengths:

• Proven manufacturing capacity with consistent product quality
• Competitive pricing due to local production efficiencies
• Experience supplying to global markets

Considerations:

• Need for rigorous third-party audits due to regional regulatory perceptions
• Long lead times common in sourcing from Chinese suppliers

2. Zhejiang Hisun Pharmaceuticals (China)

A major Chinese pharmaceutical company with extensive experience in anticancer APIs, including epirubicin hydrochloride. The company emphasizes stringent quality control and has received approvals from regulatory bodies like the CFDA and EMA.

Strengths:

• Established R&D for process optimization
• Ability to meet large-volume orders
• Compliance with regulatory standards

Considerations:

• Export restrictions or documentation requirements in certain markets
• Potential logistical delays stemming from regional disruptions

3. Biotech Pharmaceuticals (India)

Biotech Pharmaceuticals is a reputed Indian API manufacturer with a focus on complex chemotherapeutic agents. The firm adheres to cGMP standards and has obtained approvals from the Drug Controller General of India (DCGI).

Strengths:

• Strong reputation for quality manufacturing
• Competitive prices aligned with export markets
• Experience with international regulatory filings

Considerations:

• Capacity constraints may limit supply volumes
• Quality validation needed for new clients

4. Lillu Pharmaceuticals Ltd. (South Korea)

Lillu Pharmaceuticals specializes in high-active and cytotoxic APIs, including epirubicin hydrochloride. The company emphasizes innovation and quality assurance and holds certifications like ISO 9001 and GMP.

Strengths:

• Advanced manufacturing technologies
• Proven track record with global pharmaceutical firms
• Excellent regulatory compliance

Considerations:

• Higher procurement costs relative to Chinese or Indian counterparts
• Limited capacity for very large orders

5. European and North American API Suppliers

While fewer in number, certain European and North American firms serve global markets:

• APISource Inc. (USA): Focuses on high-quality, regulatory-compliant APIs; offers comprehensive documentation.
• Biosynt (Germany): Known for microbiological synthesis and bio-processed APIs, with a growing portfolio that includes epirubicin hydrochloride.

Strengths:

• Superior regulatory recognition and trust
• Extensive quality assurance protocols

Considerations:

• Higher cost structures, often with limited capacity
• Longer lead times due to regulatory and logistical procedures

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Considerations for Selecting API Suppliers

• Regulatory Certification: Confirm the supplier holds relevant certifications (e.g., cGMP, ISO, WHO-GMP).
• Quality Control: Ensure comprehensive QC reports, stability data, and Batch Production Records (BPR).
• Production Capacity: Match supplier capacity with current and projected clinical or commercial needs.
• Supply Chain Reliability: Evaluate supplier stability, geopolitical considerations, and logistical efficiency.
• Price and Lead Time: Balance cost competitiveness with timely delivery, especially critical for manufacturing schedules.

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Emerging Trends in API Sourcing for Epirubicin Hydrochloride

• Increased reliance on regional manufacturing: To mitigate supply disruptions, pharmaceutical companies are diversifying API sources, especially from Asia.
• Focus on Quality Assurance: Regulatory bodies, such as the FDA and EMA, increasingly scrutinize API manufacturing; suppliers with robust documentation gain preference.
• Supply chain transparency: Blockchain and digital tracking are becoming tools to enhance traceability, ensuring authenticity and quality.

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Regulatory and Quality Standards

API suppliers must adhere to international standards to facilitate global distribution:

• cGMP Compliance: Critical for APIs used in injectable formulations.
• ISO Certification: Demonstrates adherence to quality management systems.
• Whistleblower and Audit Reports: Essential for verifying supplier integrity.

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Conclusion

The global market for epirubicin hydrochloride API features reputable suppliers primarily from China, India, South Korea, and select European entities. Biotech and pharmaceutical companies must carefully vet suppliers based on quality certifications, production capacity, regulatory compliance, and logistical reliability to ensure consistent, safe, and efficacious end-products.

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Key Takeaways

• Multiple regional suppliers provide high-quality epirubicin hydrochloride APIs, with Chinese and Indian manufacturers dominating due to cost and capacity advantages.
• Regulatory compliance and rigorous quality assurance are paramount; verified certifications and audit reports are essential criteria.
• Diversification of suppliers mitigates risks associated with geopolitical or logistical disruptions.
• Emerging technologies improve supply chain transparency, fostering safer procurement.
• Early engagement with suppliers, detailed technical validation, and compliance documentation streamline regulatory approvals and market entry.

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FAQs

1. What are the primary regulations that API manufacturers for epirubicin hydrochloride must comply with?
Manufacturers must adhere to cGMP standards, ISO certifications, and regional regulatory requirements such as WHO-GMP, EMA, and FDA guidelines to ensure product quality and facilitate international approval processes.

2. How can pharmaceutical companies verify the quality of epirubicin hydrochloride API suppliers?
Verification involves reviewing certifications, conducting audits, requesting Batch Certification and QC documents, and analyzing past regulatory compliance records. Additional third-party inspections or assessments by procurement specialists can enhance validation.

3. What are the key differences between Chinese, Indian, and European API suppliers?
Chinese and Indian suppliers generally offer more cost-effective APIs with extensive capacity, while European suppliers often provide higher assurance levels with robust regulatory recognition but at higher prices. Capacity, certifications, and supply chain reliability vary among these regions.

4. How does regional geopolitical stability influence API sourcing decisions?
Regional stability influences supply reliability; countries with geopolitical tensions or regulatory uncertainties may pose risks to continuous API supply. Diversifying sources and establishing safety stocks mitigate such risks.

5. What future trends are likely to impact epirubicin hydrochloride API sourcing?
Expect increased transparency via digital tracking, greater emphasis on sustainable and compliant manufacturing practices, and diversification toward regional manufacturers to reduce dependency on traditional supply chains. Regulatory harmonization efforts also aim to streamline global approvals.

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Sources
[1] Global Pharmaceutical API Market Analysis, 2022.
[2] Chinese GMP Certification Standards, State Food and Drug Administration.
[3] Indian Drug Regulatory Framework, DCGI Reports.
[4] European Medicines Agency (EMA) Guidelines for APIs.
[5] Industry Reports on Anthracycline API Manufacturing, 2023.