Bulk Pharmaceutical API Sources for MOMELOTINIB DIHYDROCHLORIDE

Bulk Pharmaceutical API Sources for MOMELOTINIB DIHYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
MolCore BioPharmatech		MC34203
Angene Chemical		AGN-PC-0WD7JW
AbaChemScene		CS-0056511
Hairui Chemical		MOXM012
001Chemical		DY34203
Synblock Inc		SB14601
BLD Pharm		BD00949258

Bulk Active Pharmaceutical Ingredient (API) Sources for: MOMELOTINIB Dihydrochloride

Last updated: July 30, 2025

Introduction

Momeletinib Dihydrochloride is an emerging targeted therapy, advancing its position in oncology treatment landscapes due to its selective kinase inhibition profile. As the pharmaceutical industry approaches commercialization and wider clinical adoption, securing reliable sources of high-quality bulk API becomes paramount. Given the complexity of synthesizing Momeletinib Dihydrochloride, understanding the global landscape of API manufacturers is essential for pharmaceutical companies, contract manufacturing organizations (CMOs), and research institutions aiming to procure this compound efficiently and compliant with regulatory standards.

Overview of Momeletinib Dihydrochloride

Momeletinib, a novel tyrosine kinase inhibitor, exhibits potent activity against specific receptor pathways implicated in oncogenesis, including the alterations in the epidermal growth factor receptor (EGFR) family. Its dihydrochloride salt form enhances solubility and stability, facilitating formulation development. Manufacturing Momeletinib Dihydrochloride involves complex multi-step synthesis, requiring advanced chemical capabilities, which narrows the field of qualified suppliers.

Global API Manufacturing Landscape

The sourceability of Momeletinib Dihydrochloride hinges upon several key factors:

• Manufacturing Expertise: Synthesis pathways involve intricate organic reactions, chiral centers, and sensitive steps necessitating specialized skill.
• Regulatory Compliance: Suppliers must adhere to cGMP standards, with batch documentation, purity analysis, and stability data aligning with international pharmacopeial guidelines.
• Capacity & Scalability: Ensuring the ability to supply trial, clinical, and commercial-scale quantities.
• Quality Assurance: Rigorous testing for impurities, residual solvents, and endotoxins.

Currently, the principal sources of Momeletinib Dihydrochloride API are predominantly located within Asia, especially China and India, owing to their extensive chemical manufacturing infrastructure and experience with complex APIs.

Leading API Suppliers for Momeletinib Dihydrochloride

1. Chinese API Manufacturers

a. Zhejiang Hisun Pharmaceutical

• Capabilities: Known for complex synthetic APIs, Hisun possesses advanced R&D facilities and cGMP-certified manufacturing plants. They've demonstrated capacity in kinase inhibitors and related targeted therapies, making them a potential supplier for Momeletinib Dihydrochloride.
• Certifications: ISO 9001, ISO 14001, and FDA approval for certain APIs.
• Strengths: Vertical integration and experience with high-potency compounds facilitate reliable bulk production.

b. Zhejiang NHU Co., Ltd.

• Capabilities: This manufacturer specializes in fine chemicals and active pharmaceutical ingredients, emphasizing oncology APIs.
• Quality Assurance: Strict quality systems ensure products meet international specifications, including stability-indicating assays relevant for kinase inhibitors.

c. Shanghai ChemPartner

• Capabilities: A contract manufacturer with advanced synthetic chemistry expertise, potentially capable of custom synthesis of Momeletinib Dihydrochloride at various scales.
• Complementary Services: Analytical development, process optimization, and scale-up.

2. Indian API Manufacturers

a. Divi's Laboratories

• Capabilities: Renowned for complex molecule synthesis, including kinase inhibitors and other targeted therapies.
• Regulatory Track Record: Has achieved approvals for various APIs globally, including US FDA and EMA.
• Capacity: Significant manufacturing scale with flexible production capabilities to support clinical trials and commercialization.

b. GVK Biosciences (AstraZeneca subsidiary)

• Capabilities: Offers contract development and manufacturing services in high-value APIs, emphasizing high potency and complex chemistry.
• Research & Development: Maintains advanced laboratories for process R&D, which can facilitate custom synthesis of Momeletinib Dihydrochloride.

c. Laurus Labs

• Capabilities: Focuses on small molecule APIs, with capabilities in complex synthetic routes and high purity standards critical for kinase inhibitors.

3. Western API Manufacturers and Contract Service Providers

While less common, a few specialized Western CROs and CMOs may develop and supply Momeletinib Dihydrochloride via custom synthesis agreements, especially for early-phase clinical material. Notably, companies like Evonik and ASK CHEMICALS have the capacity for complex API synthesis and could serve as potential partners for prototype or lower-volume supply.

Key Factors in Selecting API Suppliers

• Regulatory Compliance: Prioritizing suppliers with proven cGMP certification and a track record of successful regulatory submissions.
• Quality Control Measures: Suppliers should provide comprehensive impurity profiles, residual solvent analysis, and stability data.
• Process Transparency: Availability of detailed process documentation, batch records, and process validation reports.
• Supply Chain Security: Consideration of geopolitical stability, manufacturing capacity, and contingency planning to mitigate supply disruptions.
• Economic Considerations: Price competitiveness balanced with quality and regulatory standards.

Emerging Manufacturing Technologies and Future Outlook

Advancements such as continuous flow synthesis, biocatalysis, and process intensification are increasingly employed in complex API manufacturing. These innovations may facilitate more efficient routes for Momeletinib Dihydrochloride, reducing costs and lead times. Additionally, partnerships with Contract Development and Manufacturing Organizations (CDMOs) specializing in oncology agents are expected to expand, enhancing supply chain robustness.

Regulatory and Commercial Considerations

Manufacturers must align with global standards, including ICH Q7 guidelines for active pharmaceutical ingredients, to facilitate registration in major markets like the US, EU, and Japan. Establishing quality agreements and validation dossiers is integral to ensuring downstream regulatory approvals.

Conclusion

The sourcing of Momeletinib Dihydrochloride API requires evaluating a nexus of technical capabilities, regulatory compliance, and supply chain security. Leading Chinese and Indian manufacturers occupy the forefront, backed by extensive manufacturing infrastructure and regulatory experience. Pharmaceutical entities must implement rigorous qualification processes, emphasizing quality assurance and compliance, to ensure a reliable supply of high-purity API essential for clinical and commercial success.

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Key Takeaways

• Global suppliers are primarily based in China and India due to their advanced chemical manufacturing infrastructure.
• Selection hinges on regulatory compliance, manufacturing capacity, and proven quality systems.
• Emerging manufacturing technologies will likely reduce costs and lead times.
• Contracts with reliable CMOs and thorough qualification processes mitigate supply risks.
• Early engagement with suppliers enhances alignment on process development, scale-up, and regulatory documentation.

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FAQs

1. What are the main challenges in sourcing Momeletinib Dihydrochloride API?
The primary challenges include complex synthesis routes requiring advanced chemistry, maintaining high purity and stability standards, and ensuring regulatory compliance across manufacturing sites.

2. Are there any Western manufacturers capable of producing Momeletinib Dihydrochloride at scale?
While most production is concentrated in Asia, some Western CROs and CMOs with expertise in complex synthesis may offer custom production services, though scalability and cost may vary.

3. How does process development influence API sourcing?
Efficient process development can streamline synthesis pathways, improve yields, and reduce costs, making suppliers more attractive and enabling scalable production.

4. What regulatory considerations should be addressed when sourcing APIs?
Suppliers must comply with cGMP standards, provide detailed documentation, and have a proven track record of successful regulatory submissions in target markets.

5. How can supply chain risks be mitigated for critical APIs?
Diversifying suppliers, establishing long-term agreements, and conducting regular audits are essential strategies. Additionally, engaging with CMOs capable of rapid scale-up and process adaptation is vital.

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References

1. U.S. Food and Drug Administration. GMP Compliance Monitoring.
2. European Medicines Agency. Guidelines on Good Manufacturing Practice.
3. Chinese Pharmacopoeia and Indian Pharmacopoeia standards for pharmaceutical ingredients.
4. Industry reports on complex API manufacturing capabilities and trends.

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Note: Specific supplier names are indicative; companies' capacities should be verified through direct engagement and qualification processes.