Bulk Pharmaceutical API Sources for brigatinib

Bulk Pharmaceutical API Sources for brigatinib

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-12857
AbaChemScene		CS-4278
ChemShuttle		140455
AbovChem LLC		HY-12857
AKos Consulting & Solutions		AKOS030257612
Activate Scientific		AS59455

Bulk Active Pharmaceutical Ingredient (API) Sources for Brigatinib

Last updated: July 29, 2025

Introduction

Brigatinib is a targeted selective tyrosine kinase inhibitor used primarily for the treatment of ALK-positive non-small cell lung cancer (NSCLC). As an essential component in pharmaceutical manufacturing, sourcing high-quality bulk brigatinib API is crucial for ensuring drug efficacy, safety, and regulatory compliance. This article explores the landscape of API suppliers, evaluating their capabilities, market positioning, quality standards, and regulatory adherence to facilitate informed procurement decisions.

Overview of Brigatinib API

Brigatinib (brand name Alunbrig) received FDA approval in 2017 for treating ALK-positive NSCLC. Its complex chemical structure and synthesis processes demand reputable, compliant API suppliers capable of consistent quality delivery at commercial scales. The API’s synthesis involves multiple steps, including stereoselective reactions and strict impurity control, making supplier selection critical to maintain pharmaceutical integrity.

Key Criteria for API Sourcing

Selecting a supplier for brigatinib API involves evaluating several core factors:

• Regulatory Compliance: Suppliers must hold current certifications such as cGMP (current Good Manufacturing Practices), ISO certifications, and adhere to regional regulations (FDA, EMA, PMDA, etc.).
• Quality Assurance: Robust quality management systems, rigorous testing, and analytical validation are non-negotiable for ensuring API purity and potency.
• Manufacturing Capacity: Capable of scaling production to meet demand fluctuations and maintain consistent supply.
• Technical Expertise: Proven experience in complex synthesis pathways and impurity profiling specific to kinase inhibitors.
• Logistics & Supply Chain: Reliable delivery timelines, packaging standards, and warehousing practices to prevent contamination.

Leading API Suppliers for Brigatinib

1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Overview: Hisun Pharma is a major Chinese biopharmaceutical enterprise with extensive experience in synthesizing kinase inhibitors, including brigatinib. They possess cGMP-certified facilities and have established export channels for APIs.

Strengths:

• Proven manufacturing capacity for complex APIs.
• Compliant with international quality standards.
• Competitive pricing due to scale.

Considerations:

• Ensuring rigorous supplier audits for quality verification.
• Potential customs and regulatory complexities in Western markets.

2. Hikal Ltd. (India)

Overview: Hikal offers a broad portfolio of pharmaceutical intermediates and APIs, including specialized kinase inhibitors. Their facilities are FDA-approved and adhere to global cGMP standards.

Strengths:

• Established compliance with US FDA and EMA standards.
• Advanced analytical and validation capabilities.
• Strong R&D for process optimization.

Considerations:

• Longer lead times compared to local suppliers.
• Certification updates needed for new markets.

3. Jubilant Biosys (India)

Overview: Jubilant Biosys specializes in custom synthesis and API manufacturing, providing scalable solutions for complex molecules like brigatinib. Their integration across R&D and manufacturing enhances process control.

Strengths:

• Expertise in kinase inhibitor synthesis.
• High-quality standards, validated by global clients.
• Integrated research to streamline synthesis pathways.

Considerations:

• Price competitiveness depends on volume.
• Supply chain robustness in faster-moving markets.

4. WuXi AppTec (China/Global)

Overview: WuXi is a leading Contract Research, Development, and Manufacturing Organization (CRDMO), with capacity for API development and manufacturing at commercial scales. Their extensive global network supports regulatory filings.

Strengths:

• Advanced technologies in synthesis and analytical testing.
• Fully compliant with global regulatory frameworks.
• Ability to support early-stage development to commercial production.

Considerations:

• Higher cost structure compared to regional manufacturers.
• Longer lead times during capacity allocation.

5. Synthesis Partners and Emerging Suppliers

Emerging suppliers in Europe and North America are increasingly investing in kinase inhibitor production capabilities. Companies such as Polpharma (Poland) and MedPharm (UK) are expanding their portfolios and emphasizing quality compliance, although current capacity for brigatinib may be limited.

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Regulatory and Quality Considerations

Ensuring supplier compliance with pharmacopoeial standards (USP, EP, BP) and international regulatory requirements is non-negotiable. Pharmacovigilance through detailed audit trails, batch records, and analytical certificates of analysis (CoA) are essential to verify API quality consistency.

Furthermore, suppliers with EMA or FDA-approved facilities can expedite regulatory submissions and facilitate market entry. The emergence of global APIs markets, particularly in Asia, demands diligent verification, as regional suppliers may vary in their regulatory rigor.

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Market Dynamics and Trends

The demand for brigatinib API is projected to grow with increasing prevalence of ALK-positive NSCLC. Factors influencing sourcing decisions include:

• Supply chain resilience: Civil disruptions, geopolitical factors, and trade policies influencing supplier reliability.
• Cost considerations: Price variations driven by manufacturing scale and regional economic factors.
• Quality standards: Stricter regulatory scrutiny elevates the importance of suppliers with proven validation histories.

The COVID-19 pandemic underscored the need for diversified sourcing strategies, prompting many pharmaceutical companies to establish multiple suppliers or transition to more reliable regions.

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Conclusion

Sourcing high-quality brigatinib API remains a critical step in ensuring the success of pharmaceutical products targeting ALK-positive NSCLC. Leading global suppliers include Zhejiang Hisun Pharmaceutical, Hikal Ltd., Jubilant Biosys, and WuXi AppTec, each offering distinct advantages in capacity, compliance, and technological expertise.

Due diligence, regulatory adherence, and maintaining a diversified supplier base are essential for secure, compliant, and cost-effective brigatinib API procurement. Strategic supplier partnerships, coupled with rigorous quality assurance protocols, underpin the robustness of the supply chain for this complex molecule.

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Key Takeaways

• Regulatory Compliance is Paramount: Choose suppliers with validated cGMP facilities, current certifications, and proven quality systems.
• Diversify Suppliers: Mitigate supply chain risks by engaging multiple suppliers across regions with proven track records.
• Evaluate Technical Capabilities: Confirm supplier expertise in kinase inhibitor synthesis and impurity profiling to ensure API purity.
• Align Cost with Quality: Balance competitive pricing with quality assurance; avoid compromising regulatory standards.
• Monitor Market Trends: Stay abreast of geopolitical, logistical, and regulatory developments impacting API sourcing for brigatinib.

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FAQs

1. What are the primary regions producing brigatinib API?
Asia, particularly China and India, dominate manufacturing due to large-scale facilities and cost advantages. Europe and North America host specialized suppliers with strict regulatory oversight.

2. How important is cGMP certification when sourcing brigatinib API?
Crucial. cGMP certification ensures the supplier complies with quality standards necessary for pharmaceutical manufacturing, regulatory approval, and patient safety.

3. Can emerging suppliers reliably provide high-quality brigatinib API?
Yes, provided they have validated facilities, rigorous quality management systems, and regulatory approvals. Due diligence is essential to verify their compliance and technical capabilities.

4. What are typical lead times for brigatinib API orders?
Lead times vary based on supplier capacity, order size, and regulatory clearance but generally range from 12 to 24 weeks, emphasizing the need for early planning.

5. How does regional regulation impact API sourcing decisions?
Regulatory frameworks differ globally; selecting suppliers with approvals aligned with target markets expedites registration processes and reduces compliance risks.

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References

[1] U.S. Food and Drug Administration (FDA). Alunbrig (brigatinib) NDA Approval. 2017.
[2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice. 2013.
[3] Pharmaceutical Technology. Sourcing complex APIs: Challenges and strategies. 2022.
[4] Industry Reports. Global API Manufacturing Landscape. 2021.
[5] Company Websites and Certifications. Zhejiang Hisun Pharmaceutical, Hikal Ltd., Jubilant Biosys, WuXi AppTec.