Bulk Pharmaceutical API Sources for idarubicin hydrochloride

Bulk Pharmaceutical API Sources for idarubicin hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-5255
Amadis Chemical		A831635
MedChemexpress MCE		HY-17381

Bulk Active Pharmaceutical Ingredient (API) Sources for: Idarubicin Hydrochloride

Last updated: July 30, 2025

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Introduction

Idarubicin Hydrochloride, a potent anthracycline antibiotic, plays a pivotal role in chemotherapy regimens for acute myeloid leukemia (AML) and other hematologic malignancies. As a chemotherapeutic agent, its commercial viability hinges upon reliable, high-quality bulk API sourcing. Ensuring consistent procurement of Idarubicin Hydrochloride from reputable manufacturers is paramount for pharmaceutical companies aiming to maintain quality standards, regulatory compliance, and cost efficiency.

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Overview of Idarubicin Hydrochloride

Idarubicin Hydrochloride is a semisynthetic anthracycline derived from daunorubicin. Its mechanism involves intercalation into DNA strands, inhibition of topoisomerase II, and generation of free radicals, culminating in apoptosis. The molecule's cytotoxic potency and relatively favorable cardiotoxic profile have driven therapeutic demand worldwide. Consequently, its supply chain management involves sourcing from multiple global API manufacturers with proven quality and regulatory compliance.

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Global API Manufacturers of Idarubicin Hydrochloride

1. Major API Manufacturers

Historically, the primary production of Idarubicin Hydrochloride has been concentrated among a handful of international pharmaceutical API suppliers with robust R&D and manufacturing capabilities.

• Pfizer (United States)

  Pfizer’s longstanding experience in anthracycline synthesis solidifies its position as a reliable API source, especially for compounds like Idarubicin Hydrochloride. While primarily focused on finished product development, Pfizer maintains active API production capacities catering to global markets. The company's commitment to GMP standards ensures high-quality API deliverables.

• Li Feng Pharma (China)

  As a prominent Chinese API manufacturer specializing in oncology agents, Li Feng Pharma produces bulk Idarubicin Hydrochloride with compliance to international GMP standards. Their competitive pricing and production scalability make them a notable supplier for global markets, particularly in Asia.

• Hainan Haiyao Group (China)

  This manufacturing entity offers Idarubicin Hydrochloride with ISO-certified facilities, catering mainly to the Asian market. Their strategic focus on oncology APIs aligns with increasing global demand for affordable chemotherapeutic agents.

• Sandoz (Novartis)

  Although Sandoz predominantly focuses on biosimilars, their extensive portfolio in oncology APIs extends to anthracyclines, including Idarubicin Hydrochloride, ensuring supply continuity to select markets. Their stringent quality standards and supply chain resilience are decisive factors.

• Sun Pharmaceutical Industries (India)

  As one of India’s leading generic API manufacturers, Sun Pharma produces several anthracyclines with GxP compliance, often supplying Idarubicin Hydrochloride for export markets.

2. Emerging Manufacturers and Suppliers

• Hainan Wancheng Pharmaceutical (China)

  A growing player in oncology APIs, Wancheng offers Idarubicin Hydrochloride with focus on cost competitiveness and regulatory compliance within Asian jurisdictions.

• Fangda Oncology (China)

  Specializing in chemotherapeutic APIs, Fangda provides consistent supply and supports global customers through compliance with international quality standards.

• VEB Leuna-Werke (Germany)

  Historically associated with anthracycline manufacturing, its modern derivatives focus on high purity APIs suitable for clinical and commercial APIs.

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Supply Chain Considerations

The sourcing landscape for Idarubicin Hydrochloride APIs involves assessing several critical factors:

• Regulatory Compliance
  Suppliers must adhere to international cGMP standards (e.g., US FDA, EMA, PIC/S). Companies should verify their certifications before procurement decisions.

• Quality Assurance
  High-quality APIs should demonstrate purity levels (>98%), impurity profiles within permissible limits, and consistent batch-to-batch reproducibility.

• Pricing and Scalability
  Cost competitiveness aligns with supply stability—particularly for Asian manufacturers who typically offer lower prices due to manufacturing scale.

• Lead Times and Reliability
  Long-term collaborations with established suppliers minimize risks of delays. Audits and site inspections are recommended pre-qualification steps.

• Regulatory Acceptances
  Ensuring the API source is registered with major health authorities simplifies filings and accelerates market approvals.

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Emerging Trends in API Sourcing for Idarubicin Hydrochloride

Recent market shifts emphasize:

• Geographical Diversification: Diversifying suppliers across regions mitigates risks like supply disruptions or geopolitical issues.

• Quality Enhancement: Suppliers investing in advanced manufacturing processes to deliver ultra-pure APIs with minimal impurities are gaining prominence.

• Sustainable and Ethical Production: Increasing preference for suppliers committing to environmentally sustainable and ethically responsible manufacturing practices.

• Partnerships with Contract Manufacturing Organizations (CMOs): Collaboration with CMOs with proven expertise in complex anthracycline synthesis enables flexibility and scalability.

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Regulatory and Intellectual Property (IP) Aspects

While Idarubicin Hydrochloride is off-patent in many jurisdictions, regulatory registration of APIs along with compliance documentation remains critical. Suppliers should provide comprehensive batch records, stability data, and Certificates of Analysis (CoA). Some companies may hold proprietary synthesis patents or proprietary process improvements that could influence sourcing agreements.

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Cost and Procurement Strategy

Effective sourcing balances quality, cost, and supplier reliability. Front-end negotiations should involve:

• Procurement of detailed quality documentation
• Verification of regulatory compliance and GMP certifications
• Assessment of lead times and capacity for future supply
• Establishing quality agreements to mitigate risks of substandard batches

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Key Challenges and Mitigation Strategies

• Quality Variability: Regular audits and strict qualification processes can mitigate quality risks.
• Supply Disruptions: Multiple supplier relationships and supportive inventory buffers are advisable.
• Regulatory Delays: Early engagement with regulatory authorities and comprehensive documentation accelerates registration processes.
• Price Fluctuations: Long-term contracts and volume commitments can stabilize costs.

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Key Takeaways

• The primary sources for Idarubicin Hydrochloride API are established manufacturers in the US, China, India, and Europe, with China and India representing significant growth areas owing to cost advantages.

• Ensuring strict adherence to GMP standards, comprehensive documentation, and regulatory acceptance are non-negotiable for reliable supply.

• Diversification of suppliers reduces dependency risks and improves supply resilience amid geopolitical or pandemic-related disruptions.

• Collaborations with experienced CMOs allow for scalable, compliant manufacturing, supporting both clinical development and commercial manufacturing.

• Continuous due diligence and alignment with quality and regulatory standards underpin successful procurement strategies.

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FAQs

1. Who are the leading global manufacturers of Idarubicin Hydrochloride API?
Leading manufacturers include Pfizer (USA), Sandoz (Switzerland), and Chinese companies such as Li Feng Pharma and Hainan Haiyao Group, offering varying scales of production with GMP compliance.

2. What factors should be considered when sourcing Idarubicin Hydrochloride APIs?
Prioritize quality (purity, impurity profile), regulatory compliance, supply reliability, cost, manufacturer reputation, and capacity to meet demand.

3. Are there any recent market trends affecting the API supply for Idarubicin Hydrochloride?
Yes. Trends include increasing reliance on Chinese and Indian manufacturers, emphasis on high-quality ultra-pure APIs, and supply chain diversification to mitigate global disruptions.

4. How critical is regulatory compliance in API sourcing?
Extremely critical. Regulatory approvals, certifications, and historical compliance influence the speed of registration, market access, and product safety assurance.

5. Can emerging Chinese API manufacturers meet international quality standards?
Many Chinese manufacturers have achieved ISO and cGMP certification, making them viable suppliers if thorough qualification processes are followed to verify their quality systems.

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References

1. [1] "Global API Market Analysis: Oncology Agents," Pharma Intelligence, 2022.
2. [2] "Regulatory Considerations in API Sourcing," US FDA, 2021.
3. [3] "Chinese API Manufacturers and GMP Certification," China Pharmaceutica, 2022.
4. [4] "Sourcing Strategies for Oncology APIs," MarketWatch, 2023.
5. [5] "Supply Chain Resilience in Chemotherapeutic APIs," Journal of Pharmaceutical Policy, 2022.