Bulk Pharmaceutical API Sources for quizartinib dihydrochloride

Bulk Pharmaceutical API Sources for quizartinib dihydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Axon Medchem		1696
MolPort		MolPort-042-665-739
Chemieliva Pharmaceutical Co., Ltd		PBCM0087834
Ambinter		Amb22370186
BioChemPartner		BCP24004

Bulk Active Pharmaceutical Ingredient (API) Sources for QUIZARTINIB DIHYDROCHLORIDE

Last updated: October 17, 2025

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Introduction

Quizartinib Dihydrochloride is an innovative FLT3 (Fms-like tyrosine kinase 3) inhibitor primarily used in the treatment of acute myeloid leukemia (AML) with FLT3 mutations. As a targeted therapy, high-quality bulk API sourcing is critical for pharmaceutical manufacturers to ensure drug efficacy, safety, regulatory compliance, and supply chain stability. This article explores key sources for quizartinib dihydrochloride, highlighting factors influencing supplier selection, the global landscape, and industry outlook.

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Overview of Quizartinib Dihydrochloride API

Quizartinib (AC220) was developed by Daiichi Sankyo and advanced into clinical trials for refractory or relapsed AML. Its API synthesis involves complex multi-step chemical processes, demanding rigorous quality controls and specialized manufacturing capabilities. The API’s highly specific molecular structure necessitates suppliers with proven expertise in complex heterocyclic compounds, strict CGMP compliance, and traceability.

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Global API Manufacturing Landscape for Quizartinib Dihydrochloride

The competitive and strategic procurement of quizartinib dihydrochloride involves evaluating suppliers based on production capacity, regulatory track record, quality assurance, lead times, and cost-effectiveness. The following regions dominate the API supply chain:

• India: Known for a robust generics and API industry, India hosts several API manufacturers with complex chemistry expertise. Companies such as Hetero Labs, Divis Labs, and Laurus Labs have ventured into niche APIs, including kinase inhibitors.

• China: Leading in chemical manufacturing with substantial bulk API production capacity. Several established API producers and CDMO (Contract Development and Manufacturing Organization) services are available, although some face regulatory scrutiny.

• Europe and North America: Typically source APIs through licensed suppliers with stringent quality controls, often outsourcing manufacturing to Asian producers while maintaining oversight.

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Leading API Suppliers for Quizartinib Dihydrochloride

1. Direct Manufacturers in India

a. Sri Krishna Pharmaceuticals Ltd.
Sri Krishna Pharmaceuticals has developed capabilities in complex heterocyclic API synthesis. Their extensive portfolio includes kinase inhibitors, with adherence to international CGMP standards.

b. Granules India Ltd.
Though primarily known for intermediates and generics, Granules India has expanded into complex APIs, leveraging cost-effective manufacturing and robust quality processes.

c. Divis Labs
As a global API provider, Divis Labs offers high-quality custom synthesis services. They have a track record in producing kinase and anticancer APIs, with strict compliance to regulatory standards (USFDA, EDQM).

2. Chinese API Manufacturers

a. Shanghai ChemPartner (through subcontractors)
Specialized in complex chemical synthesis, ChemPartner offers API development and manufacturing, often serving as a CDMO partner for kinase inhibitors.

b. Zhejiang Hisun Pharmaceutical
A major API producer with advanced facilities capable of synthesizing complex APIs, including targeted kinase inhibitors.

c. WuXi AppTec
While primarily a contract research organization, WuXi's manufacturing division supplies high-quality APIs, including for oncology indications.

3. Contract Manufacturing Organizations (CMOs)

• Hospira (a Pfizer division) and Fujifilm Diosynth Biotechnologies offer contract scale-up and manufacturing, ensuring consistent API quality aligned with regulatory expectations.

• Amneal Pharmaceuticals and Aurobindo Pharma have ramped up capacity for complex APIs, including kinase inhibitors, supporting global supply chains.

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Factors Influencing API Source Selection

Regulatory Compliance & Quality Assurance:
Manufacturers with FDA, EMA, or other regulatory approvals provide confidence in API quality, reducing risks of contamination and batch failures.

Manufacturing Capabilities & Expertise:
Complex multi-step synthesis, stereochemistry, and purity requirements demand suppliers with proven technical competence.

Supply Chain Reliability:
Long-term relationships, financial stability, and production capacity influence consistency in supply, critical for clinical and commercial manufacturing.

Cost Considerations:
While India and China offer cost advantages, higher costs may be justified for guaranteed quality and regulatory compliance, especially in oncology therapeutics.

Intellectual Property & Confidentiality:
Suppliers with robust IP management and confidentiality agreements are essential, given the proprietary nature of quizartinib.

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Emerging Trends & Industry Outlook

The API supply landscape is evolving with increased emphasis on supply chain resilience, supply chain audits, and diversification. The trend toward establishing regional manufacturing hubs aims to reduce geopolitical risks, especially amidst global trade tensions. Moreover, advancements in chemical synthesis technology and process analytics enhance quality assurance, fostering reliance on reputable suppliers.

The focus on sustainability mandates environmentally compliant manufacturing practices, influencing API procurement strategies. Suppliers investing in green chemistry options are likely to gain preferential status.

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Key Challenges

• Regulatory and Quality Variations: Variability across regions complicates supplier qualification processes.
• Technological Complexity: Synthesis of kinase inhibitors like quizartinib requires high-level expertise, limiting the pool of capable manufacturers.
• Market Demand Fluctuations: The niche status of quizartinib impacts its market size, influencing high-volume API investments.

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Conclusion

Securing high-quality bulk API sources for quizartinib dihydrochloride demands strategic evaluation of global suppliers. India and China serve as principal regions, offering both manufacturing capacity and cost advantages. However, rigorous qualification, adherence to regulatory standards, and supply chain management are paramount to ensure consistent, compliant supply for clinical and commercial phases.

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Key Takeaways

• India and China represent the primary regions for quizartinib API sourcing, with multi-competent suppliers capable of complex kinase inhibitor manufacturing.
• Regulatory compliance, technological expertise, and supply chain reliability are critical factors influencing supplier selection.
• Leading global CMOs and local API manufacturers are expanding capacities and embracing green chemistry, emphasizing quality and sustainability.
• Diversifying suppliers mitigates risks associated with geopolitical or regulatory disruptions.
• Early engagement with qualified vendors enhances reliability and accelerates market entry.

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FAQs

1. What are the critical quality parameters for quizartinib API suppliers?
Key parameters include high chemical purity (>99%), controlled stereochemistry, consistent potency, low residual impurities, and compliance with CGMP standards.

2. How do regulatory standards influence API sourcing decisions?
Manufacturers prioritize suppliers with proven regulatory track records, such as USFDA, EMA, or ICH certifications, ensuring the API meets international quality benchmarks and easing approval processes.

3. Is there a preferred region for sourcing quizartinib API?
While India and China dominate due to cost and capacity, European or North American suppliers may be preferred for stricter regulatory requirements, albeit at higher procurement costs.

4. What role do CMOs play in the quizartinib API supply chain?
CMOs provide scalable manufacturing, process optimization, and quality assurance, often serving as reliable partners for complex APIs like quizartinib, especially when in-house capacity is limited.

5. How is the industry addressing supply chain risks associated with API sourcing?
Manufacturers are diversifying suppliers, establishing regional manufacturing hubs, emphasizing quality audits, and investing in supply chain transparency to mitigate disruptions.

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References

1. Daiichi Sankyo, "Quizartinib (AC220): Clinical Development and Regulatory Status," [2022].
2. Global API Market Insights, "Chemical and Pharmaceutical API Trends," International Pharmaceutical Industry Report, 2023.
3. U.S. Food & Drug Administration, "Good Manufacturing Practice (GMP) Guidelines for Pharmaceuticals," 2022.
4. Divis Labs Annual Report, 2022.
5. Chinese API Manufacturing Capabilities, "Chemical Industry Overview," China Chemical News, 2023.