Bulk Pharmaceutical API Sources for glasdegib maleate

Bulk Pharmaceutical API Sources for glasdegib maleate

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		PZ0303_SIGMA
Tocris Bioscience		6538
AA BLOCKS		AA01FG7O
Lan Pharmatech		LAN-B53145
THE BioTek		bt-269520

Bulk Active Pharmaceutical Ingredient (API) Sources for: Glasdegib Maleate

Last updated: August 2, 2025

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Introduction

Glasdegib maleate is an oral, small-molecule inhibitor targeting the Hedgehog signaling pathway, primarily used in treating acute myeloid leukemia (AML). As a critical component in pharmaceutical manufacturing, sourcing high-quality bulk API is vital for ensuring consistency, efficacy, and regulatory compliance. This article offers a comprehensive analysis of the global suppliers and sources for glasdegib maleate API, emphasizing the strategic considerations for pharmaceutical manufacturers, regulatory authorities, and investors.

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Overview of Glasdegib Maleate

Glasdegib maleate, chemically designated as (4S,5R,6S)-3-(2-chloro-4-iodophenyl)-2-methyl-4,5-dihydro-3H-pyrazole-1-carboxamide maleate, operates as a potent inhibitor of the Smoothened (SMO) receptor in the Hedgehog pathway. Approved by the FDA, it is marketed under the brand name Daurismo (Pfizer) for AML treatment. The API's synthesis involves complex multi-step processes, including chiral synthesis and halogenation, necessitating reliable, compliant manufacturing partners.

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Global API Manufacturing Landscape for Glasdegib Maleate

1. Key Geographic Regions

• United States & Europe: The epicenters of pharmaceutical quality standards, with stringent GMP requirements. Suppliers often have advanced cGMP facilities, but prices tend to be higher due to rigorous regulatory compliance.

• Asia (China, India, South Korea): The dominant sourcing regions for bulk Active Pharmaceutical Ingredients, offering cost-effective production with rapidly expanding capacity. Notably, Chinese and Indian pharmaceutical manufacturers have increased their investment in APIs for complex molecules like glasdegib maleate.

• Other Regions: Emerging markets with improving GMP infrastructure, though due diligence on quality assurance is essential.

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2. Leading API Manufacturers and Suppliers

a. Pfizer Inc. (Brand Owner & Co-Development Partner):
While Pfizer manufactures glasdegib for commercial use, the company rarely supplies APIs externally. However, strategic partnerships or licensing deals may involve select API manufacturers.

b. Major Contract Manufacturing Organizations (CMOs):
Several CMOs with established expertise in complex small molecules are potential suppliers. Their capabilities are characterized by:

• Advanced synthetic route development
• Strict GMP adherence
• Strong regulatory track records

Examples include:

• WuXi AppTec (China): Offers comprehensive API manufacturing services across multiple phases, including late-stage clinical and commercial scale.
• HistoLab (India): Provides custom synthesis and bulk API production, emphasizing quality control for niches like glasdegib maleate.
• Dr. Reddy’s Laboratories (India): Known for complex molecule manufacturing, with capabilities in chiral synthesis and halogenated compounds.
• Fujifilm (Japan): Capable of high-quality API synthesis with a focus on regulatory compliance and purity.

c. Specialized API Suppliers & Distributors:
Numerous smaller entities and brokers operate in this space, often sourcing from Chinese and Indian manufacturers, offering glasdegib maleate API at reduced costs, but requiring rigorous vetting.

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Selection Criteria for API Suppliers

Quality & Compliance:
Suppliers must demonstrate compliance with cGMP standards, qualified audits, and robust quality control processes. Certificates of Analysis (CoA), stability data, and regulatory history are essential.

Capacity & Scalability:
Manufacturers should possess the infrastructure to meet current demand and scale-up for future requirements, especially considering the growth in AML treatments.

Traceability & Documentation:
Traceability of raw materials, process validation, and detailed batch documentation are non-negotiable, aligning with regulatory expectations of agencies such as the FDA and EMA.

Pricing & Lead Times:
While cost-efficiency is vital, it must not compromise quality. Lead times vary based on supplier location, capacity, and approval processes.

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Regulatory Considerations

Sourcing api for glasdegib maleate involves strict adherence to regulatory standards:

• Documentation: Suppliers must provide comprehensive dossiers demonstrating manufacturing processes, quality standards, and stability data.
• Audits: Regular factory audits and certifications (e.g., ISO, WHO-GMP) are key to validate supplier reliability.
• Legal & IP: Ensure clear licensing and absence of patent infringements, especially for molecules like glasdegib, which is proprietary to Pfizer.

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Emerging Trends & Challenges

• Supply Chain Security: The COVID-19 pandemic highlighted vulnerabilities in global API supply chains, prompting manufacturers to diversify sources.
• Quality Assurance: Increasing global regulatory scrutiny mandates rigorous quality assurance protocols.
• Cost & Lead Time Optimization: Balancing cost with regulatory compliance remains a challenge—partnering with reputable CMOs mitigates risks but may involve premium pricing.

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Conclusion

The supply landscape for glasdegib maleate API is characterized by a mix of leading North American, European, and Asian manufacturers. While qualified CMOs such as WuXi AppTec, Dr. Reddy's, and Fujifilm offer high-quality production at competitive prices, rigorous qualification processes are essential. Strategic sourcing, aligned with regulatory compliance and supply chain resilience, is critical for pharmaceutical companies aiming to maintain market supply and uphold product quality.

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Key Takeaways

• Diverse regional sourcing ensures supply security; however, stringent qualification is vital to meet quality standards.
• CMO partnerships with proven GMP track records help mitigate regulatory, quality, and supply risks.
• Cost advantages from Asian suppliers should be balanced with compliance and traceability considerations.
• Transparency and documentation are non-negotiable in API sourcing for proprietary molecules like glasdegib maleate.
• Strategic diversification of suppliers reduces dependence on single regions or vendors, safeguarding against disruptions.

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FAQs

Q1: Is glasdegib maleate API readily available from multiple suppliers?
Yes. Multiple Chinese and Indian manufacturers produce glasdegib maleate API, but buyers must conduct comprehensive due diligence to ensure quality compliance.

Q2: What are the primary factors influencing the choice of API supplier for glasdegib maleate?
Quality standards, capacity, regulatory compliance, cost, lead times, and traceability are the core decision factors.

Q3: How does regulatory oversight impact API sourcing for glasdegib maleate?
Regulatory agencies require detailed documentation, GMP certification, and consistent quality control, influencing supplier qualification and ongoing audits.

Q4: Are there risks associated with sourcing from emerging markets?
Yes. Potential risks include variable quality standards, intellectual property concerns, and supply chain disruptions. Due diligence mitigates these risks.

Q5: Can the quality of glasdegib maleate API affect the overall efficacy of the final pharmaceutical product?
Absolutely. Substandard API quality can compromise drug stability, safety, and efficacy, underscoring the importance of sourcing from accredited, compliant suppliers.

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Sources
[1] Pfizer. Daurismo (glasdegib) prescribing information.
[2] FDA. Glasdegib approval details.
[3] WHO. GMP guidelines for API manufacturing.
[4] Industry reports on global API manufacturing trends.
[5] Company websites and press releases for WuXi AppTec, Dr. Reddy’s, Fujifilm, and other relevant manufacturers.