Bulk Pharmaceutical API Sources for STREPTOZOCIN

Bulk Pharmaceutical API Sources for STREPTOZOCIN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		29327
Sigma-Aldrich		S0130_SIGMA
MolPort		MolPort-003-665-493
ABI Chem		AC1L1H7V
ChemMol		97602630
Adooq BioScience		Streptozotocin - Zanosar

Bulk Active Pharmaceutical Ingredient (API) Sources for: Streptozocin

Last updated: July 28, 2025

Introduction

Streptozocin, also known as streptozotocin or STZ, is a nitrosourea compound primarily used in chemotherapy for neuroendocrine tumors of the pancreas, particularly insulinomas, and as an experimental agent in scientific research. Due to its potent bioactivity and limited natural abundance, sourcing high-quality bulk streptozocin API remains a significant concern for pharmaceutical producers and research institutions. This report provides a comprehensive overview of key API manufacturers and suppliers specializing in streptozocin, highlighting their capabilities, regulatory compliance, and market positioning.

Overview of Streptozocin as an API

Streptozocin's unique mechanism involves DNA alkylation leading to selective pancreatic islet cell toxicity, making it effective in certain cancers but necessitating strict handling protocols owing to its potent cytotoxicity. Its synthesis involves complex chemical processes with multiple steps, requiring suppliers to maintain rigorous quality standards. Given its niche but critical application, the API market for streptozocin is characterized by limited, specialized suppliers with robust manufacturing and quality management systems.

Leading API Suppliers for Streptozocin

1. Teva Pharmaceuticals

Teva Pharmaceuticals, headquartered in Israel, is a global leader in generic and specialty pharmaceuticals. It offers sterile and non-sterile APIs, including streptozocin, primarily for research and clinical applications. Their manufacturing facilities comply with Good Manufacturing Practices (GMP), and they hold multiple certifications from regulatory authorities such as the FDA and EMA.

• Strengths: Extensive global distribution network, proven quality assurance, and consistent API production.
• Focus: Clinical trial supplies, research, and limited pharmaceutical manufacturing.
• Regulatory Compliance: GMP, ISO certifications, and active pharmacovigilance.

2. Sigmapharm Laboratories

Based in India, Sigmapharm Laboratories specializes in the synthesis of complex APIs, including streptozocin. The company emphasizes quality control, offering APIs suitable for preclinical and clinical research.

• Strengths: Cost-effective manufacturing, tailored production batches, and comprehensive testing.
• Focus: Research-grade API supply, contract manufacturing services.
• Certifications: ISO 9001, cGMP compliant.

3. Sun Pharma Advanced Research Company (SPARC)

As part of Sun Pharma, SPARC has capabilities in custom synthesis and API manufacturing, including niche compounds like streptozocin. Their facilities adhere to stringent quality standards, making them suitable for high-purity API production.

• Strengths: Innovative synthesis processes, robust quality management.
• Focus: Research and development (R&D), specialty APIs.
• Regulatory Compliance: cGMP, FDA-approved facilities.

4. GlobalAPI Suppliers: Generic and Specialty API providers

• Lynx Stock Company (China): Known for producing a variety of research APIs, including streptozocin, with GMP compliance and competitive pricing.
• Hefei Bailing Pharmaceutical (China): Offers bulk API production for research purposes, with focus on quality assurance.
• Arex Biotech (India): Specializes in cytotoxic APIs for research, including streptozocin, emphasizing affordability.

Market Dynamics and Sourcing Challenges

The scarcity of suppliers with GMP-grade streptozocin API drives a competitive landscape, especially for bulk orders. The specialized synthesis process entails strict handling and containment measures, rendering some producers unable to scale efficiently. Regulatory scrutiny regarding cytotoxic drug manufacturing further limits the pool of compliant suppliers. Consequently, organizations sourcing streptozocin must prioritize quality assurance, regulatory compliance, and reliable delivery schedules.

Regulatory and Quality Considerations

Suppliers of streptozocin API must adhere to Good Manufacturing Practices (GMP), especially when APIs are intended for clinical or commercial uses. Certifications such as FDA approval, EMA certification, or ISO 9001 are indicators of quality control. Additionally, Certificates of Analysis (CoA) with detailed testing data (HPLC purity, residual solvents, endotoxins) are vital for verifying API integrity.

Emerging Trends and Future Outlook

• Custom Synthesis and Contract Manufacturing: Growing demand for tailored APIs has led suppliers to offer bespoke synthesis services, ensuring high purity and batch-to-batch consistency.
• Regulatory Harmonization: Increased global compliance standards are streamlining supplier qualification processes.
• Potential for New Entrants: As research on neuroendocrine tumors advances, more manufacturers may enter the market, although the complex synthesis remains a barrier.

Conclusion

The key to sourcing high-quality streptozocin API lies in evaluating supplier compliance with regulatory standards, understanding their production capacity, and assessing their experience in managing cytotoxic compounds. Leading suppliers such as Teva Pharmaceuticals, Sigmapharm Laboratories, and Sun Pharma offer reliable sources, primarily serving research institutions, biotech firms, and clinical research organizations. Given the specialized nature of the API, procurement decisions should prioritize quality, regulatory adherence, and supply chain stability.

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Key Takeaways

• Limited Supplier Pool: The niche market for streptozocin API is confined to a few established manufacturers primarily in North America, India, and China.
• Regulatory Compliance is Critical: GMP certification and detailed quality documentation are essential prerequisites for API sourcing.
• Focus on Quality and Traceability: High-purity API batches with validated testing results ensure safety and efficacy in clinical applications.
• Supply Chain Stability: Due to the complex synthesis process, securing long-term supply agreements with reputable suppliers mitigates procurement risks.
• Emerging Market Dynamics: Increasing research activity could attract new suppliers, but manufacturing complexity remains a barrier.

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FAQs

1. Is streptozocin available from major pharmaceutical raw material suppliers?
Yes, suppliers like Teva, Sigmapharm, and Sun Pharma routinely offer streptozocin API, predominantly for research and clinical trial purposes, provided regulatory requirements are met.

2. What are the primary quality standards for sourcing streptozocin API?
GMP compliance, Certificates of Analysis detailing purity (often ≥98%), residual solvents, endotoxin levels, and adherence to regulatory certifications such as FDA or EMA are essential.

3. Are there synthetic alternative suppliers for streptozocin?
Current manufacturing of streptozocin involves complex chemical synthesis; alternative synthesis routes are limited, making existing suppliers crucial for availability.

4. What are the handling considerations for bulk streptozocin API?
Due to its cytotoxic nature, proper containment, handling protocols, and disposal procedures must be in place to ensure safety during storage and transportation.

5. Can research-grade streptozocin be scaled for clinical manufacturing?
While research-grade APIs are available, clinical-grade production requires stringent GMP processes. Confirm supplier GMP status before large-scale or therapeutic use.

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References

[1] Pharmaceutical supplier documentation and certifications.
[2] Regulatory guidelines for cytotoxic APIs.
[3] Market analysis reports on niche pharmaceutical APIs.
[4] Manufacturer websites and product catalogs.