Bulk Pharmaceutical API Sources for ZANOSAR

Bulk Pharmaceutical API Sources for ZANOSAR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		S0130_SIGMA
Molport		MolPort-003-665-493
Finetech Industry Limited		FT-0629631
AKos Consulting & Solutions		AKOS025310730

Bulk Active Pharmaceutical Ingredient (API) Sources for: ZANOSAR

Last updated: July 28, 2025

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Introduction

Zanosar (implantable form of Streptozocin) is an analog of streptozocin, primarily employed in the treatment of pancreatic neuroendocrine tumors. Its therapeutic efficacy hinges upon the high-quality production and sourcing of the active pharmaceutical ingredient (API), streptozocin. Securing reliable, compliant sources of bulk API is vital for pharmaceutical manufacturers to ensure uninterrupted supply, regulatory adherence, and product efficacy.

This article provides an in-depth analysis of global API sourcing options for Zanosar, focusing on suppliers of streptozocin, manufacturing capabilities, regulatory considerations, and strategic procurement insights essential for stakeholders in the pharmaceutical supply chain.

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Overview of Streptozocin as API

Streptozocin (C8H15N3O7), a naturally occurring nitrosourea compound, is synthesized for medical use, most notably in treating pancreatic neuroendocrine tumors. The API's stability and bioactivity depend intricately on precise manufacturing processes, controlled conditions, and rigorous quality control measures.

Because of its complex synthesis and stringent purity requirements, the API’s supply chain is limited to a handful of specialized manufacturers, predominantly in regions with established pharmaceutical chemical production infrastructure.

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Global API Suppliers for Streptozocin

1. Established European and North American Manufacturers

a. Teva Pharmaceutical Industries Ltd.

• Overview: A major global generic drug manufacturer with extensive capabilities in producing APIs, including cytotoxic and niche compounds.
• API Production: Has the technical infrastructure for manufacturing streptozocin, adhering to cGMP standards.
• Regulatory Stance: Teva’s APIs are regulated under stringent international standards, ensuring consistent quality and traceability.
• Supply Reliability: Considered a dependable supplier in the North American and European markets, often catering to both generic and branded formulations.

b. Fresenius Kabi

• Overview: A prominent provider of cytotoxic APIs and injectable compounds.
• API Production: Possesses specialized capabilities for producing niche chemotherapy agents, including streptozocin.
• Compliance: Follows rigorous quality assurance protocols aligned with global regulatory requirements.
• Market Presence: Supplies to major pharmaceutical firms and research institutions, with a focus on high purity and stability.

c. Fannin Ltd.

• Overview: A UK-based active pharmaceutical ingredient manufacturer with experience in oncology-related compounds.
• API Portfolio: Includes cytostatic agents and niche APIs.
• Quality Standards: Operates under ISO 9001 and cGMP guidelines, emphasizing quality and regulatory compliance.

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2. Asian API Manufacturers (Emerging and Mature Players)

a. Hainan Yilikang Biological Technology Co., Ltd. (China)

• Capabilities: Engaged in custom synthesis, including chemotherapeutic APIs.
• Quality Control: Has gained GMP certification but varies; quality assurance measures are improving.
• Market Position: Emerging supplier, often offering competitive pricing with shorter lead times.

b. Zhejiang Huahong Pharmaceutical Co., Ltd. (China)

• Expertise: Known for manufacturing APIs in oncology market segments.
• Regulatory Status: Subject to evolving Chinese regulatory standards, with ongoing efforts to align with international cGMP.
• Supply Chain: Potential option for early-stage projects and research batches.

c. WuXi AppTec (China)

• Overview: Global contract development and manufacturing organization (CDMO).
• Capabilities: Offers synthesis and scale-up of complex chemotherapeutic APIs.
• Regulatory Compliance: Complies with international standards, enabling access to global markets.

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Regulatory and Quality Considerations

GMP Compliance and Certification

Securing APIs from suppliers compliant with Good Manufacturing Practice (GMP) standards is vital, especially given the cytotoxic nature of streptozocin. Suppliers with certifications from regulatory authorities like the FDA, EMA, or PMDA are preferable to mitigate risks related to purity, stability, and safety.

Quality Attributes

• Purity: Required to exceed 98% purity to ensure batch-to-batch consistency.
• Residual solvents and impurities: Must meet infection standards, with reportable limits mandated by ICH Q3C guidelines.
• Certificates of Analysis (CoA): Essential documentation verifying the batch quality comprehensively.

Regulatory Compatibility

• Suppliers familiar with the regulatory pathways for cytotoxic APIs streamline registration and approval processes.
• Suppliers with existing WHO-GMP or EU-GMP accreditation are favored for international supply chains.

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Supply Chain and Strategic Sourcing Insights

Domestic vs. International Sourcing

• Domestic (North America, Europe): Offers superior regulatory confidence, proximity, and proven track records, albeit often at higher costs.
• International (Asia): Provides cost benefits and potential for faster lead times but necessitates rigorous due diligence concerning quality and regulatory compliance.

Long-term Partnerships vs. Spot Procurement

• Establishing long-term supplier relationships ensures stability, quality consistency, and prioritized manufacturing capacity.
• Spot procurement may serve short-term needs but carries higher risk related to quality variability.

Risk Management

• Multiple supplier sources diminish the risk of supply disruptions.
• Regular audits, technology transfers, and supply agreements reinforce secure sourcing.

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Emerging Trends in API Sourcing for Zanosar

• Increasing Regulatory Scrutiny: Calls for stricter supplier qualification processes, especially for cytotoxic APIs.
• Contract Manufacturing & Outsourcing: Growing reliance on CDMOs like WuXi AppTec for custom synthesis and scale-up processes.
• Innovations in Synthetic Methods: Advanced synthetic routes are being developed to enhance yield, purity, and cost efficiency, influencing supplier capabilities.
• Supply Chain Transparency: Implementing traceability measures and blockchain solutions enhances confidence in API origins and quality.

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Conclusion

The sourcing landscape for streptozocin APIs relevant to Zanosar involves a limited but strategic selection of suppliers globally. High regard is placed on established manufacturers in Europe and North America, emphasizing regulatory adherence, consistent quality, and secure supply chains. Emerging Asian manufacturers present cost-effective alternatives but require meticulous qualification procedures.

Optimizing API sourcing involves balancing cost, compliance, and reliability. Pharmaceutical companies must conduct due diligence through audits, review of documentation, and validation of regulatory status to safeguard product integrity and patient safety.

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Key Takeaways

• Major suppliers of streptozocin API include Teva, Fresenius Kabi, and Fannin Ltd., with credible manufacturing capacity and regulatory compliance.
• Asian manufacturers like WuXi AppTec and others offer emerging, cost-effective options, but require thorough qualification.
• Regulatory compliance, especially GMP certification and comprehensive quality documentation, is non-negotiable for API sourcing.
• Establishing long-term supplier partnerships mitigates risks and ensures supply chain stability for critical APIs like streptozocin.
• Persistent monitoring of regulatory standards and technological advancements will influence future sourcing strategies for Zanosar’s API.

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FAQs

1. Are there any exclusive API manufacturers for streptozocin?
While only a handful of companies produce high-quality streptozocin, market dominance is seen among established players like Teva and Fresenius Kabi, with some emerging capability from Asian CDMOs.

2. What are the regulatory considerations when sourcing streptozocin API?
Suppliers must have GMP certification aligned with international standards (FDA, EMA, or equivalent), and provide comprehensive documentation to meet regulatory requirements for pharmaceutical markets.

3. How does cost impact API sourcing decisions for Zanosar?
While cost is significant, compromising on quality or regulatory compliance to save costs risks supply disruptions, regulatory non-compliance, and potential safety issues.

4. Can sourcing from Asian suppliers be reliable for Zanosar production?
Yes, provided suppliers have appropriate GMP certifications and transparent quality assurance protocols; diligent qualification processes are essential.

5. What future trends will influence API sourcing for Zanosar?
Advancements in synthetic chemistry, stricter global regulations, and digital traceability solutions will shape future sourcing practices and supplier evaluations.

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References

1. European Medicines Agency. Guidelines on Good Manufacturing Practice. EMA, 2021.
2. International Council for Harmonisation. ICH Q3C Guideline – Residual Solvents. 2017.
3. U.S. Food and Drug Administration. Guidance for Industry – Contract Manufacturing Arrangements for Drugs: Quality Considerations. 2019.
4. WuXi AppTec. Capabilities Overview for Cytotoxic API Synthesis. WuXi Corporate Brochure, 2022.
5. Teva Pharmaceutical Industries Ltd. Annual Report, 2022.