Bulk Pharmaceutical API Sources for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Bulk Pharmaceutical API Sources for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D1515_SIGMA
NIH Clinical Collection		SAM001246768
NovoSeek		443939
Sigma-Aldrich		44583_SIGMA
MolPort		MolPort-003-933-100
ABI Chem		AC1L9FFU

Bulk Active Pharmaceutical Ingredient (API) Sources for: DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Last updated: August 3, 2025

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Introduction

Doxorubicin Hydrochloride (Liposomal) is a critical chemotherapeutic agent utilized broadly in oncology to treat various cancers, including breast cancer, lymphoma, and acute leukemias. Its liposomal formulation enhances drug delivery, reduces systemic toxicity, and improves clinical outcomes. As the demand for liposomal doxorubicin escalates globally, sourcing high-quality bulk APIs becomes vital for manufacturers and pharmaceutical companies committed to quality, consistency, and regulatory compliance.

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Understanding Liposomal Doxorubicin Hydrochloride

Liposomal doxorubicin involves encapsulating doxorubicin within liposomes—phospholipid bilayer vesicles—improving pharmacokinetics and reducing cardiotoxicity associated with conventional formulations. The API, doxorubicin hydrochloride, forms the foundation for manufacturing liposomal variants. Variability in API sourcing can influence formulation efficacy, safety, regulatory approval, and market competitiveness.

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Global API Manufacturers and Suppliers

The sourcing landscape for doxorubicin hydrochloride (liposomal) API is characterized by a mix of established pharmaceutical ingredient producers, contract manufacturing organizations (CMOs), and emerging competitors. Their geographic distribution includes North America, Europe, Asia, and increasingly, China and India.

1. Major Established API Manufacturers

• Pfizer Inc. (United States): As the original developer of doxorubicin, Pfizer remains a key supplier of high-quality doxorubicin hydrochloride API. Their product quality aligns with strict global regulatory standards, including FDA approvals.

• Selleck Chemicals (China): Specializes in research-grade doxorubicin hydrochloride with a focus on high purity and consistent availability. Their API, though primarily for research, is increasingly used in clinical development.

• SPL (Sun Pharmaceutical Industries Ltd., India): Offers bulk APIs, including doxorubicin hydrochloride, with compliance to international cGMP standards, making them suitable for pharmaceutical manufacturing.

• Pharmacia (Sweden): Historically involved in anthracycline production, including doxorubicin; maintains a niche presence with specialized formulations.

• Fujifilm Toyama Chemical (Japan): Provides high-quality doxorubicin APIs with strong regulatory compliance, serving Asian markets and export-focused manufacturing.

2. Contract Manufacturing Organizations and OEM Suppliers

• Hainan Yew Pharmaceutical Co., Ltd. (China): Known for producing generic APIs of anticancer agents, including doxorubicin hydrochloride, with cGMP certifications.

• AIP (American International Pharmaceuticals, USA): Focused on high-quality APIs for oncology, offering tailored API manufacturing services.

• Hangzhou Minsheng Pharmaceutical Co., Ltd.: Provides GMP-grade doxorubicin hydrochloride for bulk supply to global customers.

3. Emerging and Contract Supply Sources

• Cayman Chemical (USA): Sometimes offers research-grade APIs suitable for early-stage clinical trials.

• Baxter Healthcare (Ireland): Supplies pharmaceutical raw materials, including anticancer APIs, emphasizing compliance with EU standards.

• LTS Lohmann Therapy Systems (Germany): Focuses on specialized liposomal formulations, with API sourcing from verified suppliers compatible with Liposomal formulations.

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Criteria for Selecting API Suppliers

Choosing the right API source for liposomal doxorubicin involves rigorous evaluation based on:

• Regulatory Compliance: GMP certification, EU/FDA approvals, and quality audit history.

• API Purity and Specification: Consistent high purity (usually ≥99%), low residual solvents, endotoxin levels, and impurity profiles.

• Supply Stability: Capacity to meet commercial demand, lead times, and contingency planning.

• Documentation and Traceability: Certificates of Analysis (CoA), Certificates of Compliance (CoC), and detailed manufacturing history.

• Cost-effectiveness: Competitive pricing while maintaining quality standards.

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Challenges in API Sourcing for Liposomal Doxorubicin

• Quality Variability: Inconsistent API quality can compromise liposomal formulation stability and efficacy.

• Regulatory Barriers: Variations in regional standards necessitate compliance with multiple international regulations (FDA, EMA, PMDA).

• Supply Chain Risks: Geopolitical factors, trade restrictions, and pandemic-related disruptions can impact supply continuity.

• Intellectual Property (IP): Some APIs may be subject to patents or proprietary manufacturing processes, limiting source options.

• Manufacturing Complexity: Producing high-quality doxorubicin hydrochloride API with consistent specifications for liposomal formulations requires sophisticated facilities.

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Future Trends

The API supply landscape for liposomal doxorubicin is evolving, influenced by:

• Vertical Integration: Major pharmaceutical corporations seeking to control their supply chains for added quality assurance.

• Emerging Chinese and Indian Manufacturers: Expanding capacity to meet global demand with competitive prices, subject to rigorous regulatory acceptance.

• Regulatory Harmonization: Increased adoption of quality standards across regions to streamline sourcing and reduce barriers.

• Technological Innovations: Implementation of continuous manufacturing techniques for enhanced API quality and process robustness.

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Key Considerations for Industry Stakeholders

• Due Diligence: Conduct comprehensive audits and supplier vetting to ensure API quality and compliance.

• Partnerships: Establish long-term relationships with reputable suppliers emphasizing transparency and quality.

• Regulatory Strategy: Align sourcing choices with intended markets' regulatory requirements to facilitate approval pathways.

• Supply Chain Resilience: Diversify sources to mitigate risks and ensure uninterrupted supply for critical applications.

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Key Takeaways

• Sourcing high-quality APIs for liposomal doxorubicin demands rigorous evaluation of supplier credentials, quality standards, and supply reliability.

• Leading global manufacturers include Pfizer, Sun Pharma, Fujifilm, and specialty CROs, with emerging players in China and India expanding their footprint.

• Regulatory compliance (GMP, cGMP) remains paramount, especially for oncology APIs destined for clinical and commercial use.

• Cost considerations should balance with quality and supply stability, especially given the complexity of liposomal formulations.

• Future industry growth will likely depend on technological advancements, regulatory harmonization, and strategic supplier partnerships to meet escalating global demand.

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FAQs

Q1: What distinguishes pharmaceutical-grade API from research-grade API in sourcing doxorubicin hydrochloride?
A: Pharmaceutical-grade APIs comply with cGMP standards, ensuring stringent quality, purity, and consistency suitable for clinical and commercial manufacturing. Research-grade APIs may lack comprehensive documentation and strict quality controls, making them appropriate only for early research phases.

Q2: Are APIs from Chinese manufacturers suitable for regulatory approval in the US and EU?
A: Yes, but only if they meet strict regulatory standards, including FDA and EMA benchmarks for quality, GMP compliance, and traceability. Due diligence and comprehensive documentation are essential.

Q3: What are the risks of sourcing doxorubicin hydrochloride APIs from emerging markets?
A: Potential risks include variability in quality, regulatory differences, supply chain instability, and intellectual property concerns. These risks can be mitigated through audits, qualification batches, and supplier validation.

Q4: How does API quality impact liposomal doxorubicin formulation?
A: API quality directly affects liposomal stability, drug loading efficiency, and ultimately clinical efficacy and safety. Impurities or variability can lead to formulation failure or adverse patient outcomes.

Q5: What are key considerations when establishing a supply chain for liposomal doxorubicin API?
A: Critical factors include assessing supplier GMP compliance, ensuring consistent API purity and specifications, verifying supply capacity, establishing clear contractual terms, and maintaining regulatory documentation for compliance.

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References

1. [1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practice for Drugs.
2. [2] European Medicines Agency (EMA). Guideline on the Requirements for Quality and Manufacturing of Liposomal Drugs.
3. [3] Selleck Chemicals. Doxorubicin Hydrochloride API Data Sheets, 2022.
4. [4] Sun Pharmaceutical Industries Ltd. Corporate disclosures and API catalog, 2022.
5. [5] Regulatory filings and product datasheets from Fujifilm and Pfizer.