Bulk Pharmaceutical API Sources for SOTRADECOL

Bulk Pharmaceutical API Sources for SOTRADECOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		4_SIGMA
Sigma-Aldrich		N1404_SIGMA
Molport		MolPort-003-931-842
Sigma-Aldrich		83714_SIAL
MuseChem		M069500
Ambinter		Amb10843166
BOC Sciences		139-88-8

Bulk Active Pharmaceutical Ingredient (API) Sources for SOTRADECOL

Last updated: July 29, 2025

Overview of SOTRADECOL and Its API

SOTRADECOL is a pharmaceutical agent primarily used as an antineoplastic agent, classified within the alkylating agents used in chemotherapy. It is known chemically as dacarbazine, a cytotoxic drug effective against various cancers, including Hodgkin's lymphoma, metastatic melanoma, and soft tissue sarcomas (1). The efficacy and safety of SOTRADECOL heavily depend on the quality and supply chain integrity of its active pharmaceutical ingredient (API).

Global API Market for Dacarbazine

The global API market for dacarbazine is characterized by limited manufacturers, given the complexity of synthesis, stringent regulatory standards, and the niche therapeutic application. The key players supplying high-quality dacarbazine API are predominantly located in North America, Europe, and parts of Asia, with a few Asian-based companies emerging as significant sources of bulk API.

Major API Producers for SOTRADECOL

1. AstraZeneca

AstraZeneca is one of the pioneering pharmaceutical companies that historically manufactured dacarbazine. Though their focus has shifted towards branded formulations, they maintain intellectual property rights and supply APIs to select markets. Their manufacturing facilities adhere to strict cGMP standards, ensuring high purity levels crucial for oncology drugs (2).

2. Teva Pharmaceuticals

Teva is among the world's leading generic pharmaceutical manufacturers with capabilities in producing dacarbazine API. Their manufacturing facilities in Israel and India are capable of large-volume production, compliant with international regulatory standards. Teva's APIs are widely used for generic formulations, and they often export to North America, Europe, and Asian markets (3).

3. Jiangsu Hengrui Medicine Co., Ltd.

Based in China, Jiangsu Hengrui Medicine has established itself as a significant API manufacturer specializing in oncology compounds, including dacarbazine. Their facilities follow rigorous quality controls aligned with both Chinese and international standards, supplying both domestic and export markets (4).

4. Zhejiang Hisun Pharmaceutical Co., Ltd.

Also headquartered in China, Hisun Pharma produces a range of chemotherapeutic APIs, including dacarbazine. Their API is used in both domestic formulations and exported internationally. The company emphasizes ongoing quality certifications to satisfy global regulatory demands (5).

5. Other Notable Sources

• WuXi AppTec (China): Offers API development and manufacturing services with robust quality systems.
• Dr. Reddy’s Laboratories (India): Engaged in production of chemotherapeutic APIs, including dacarbazine, serving primarily the Indian and emerging markets.
• Lek Pharmaceuticals (Slovenia): Historically involved in producing anticancer APIs; however, their current status may be limited depending on market dynamics (6).

Supply Chain Considerations

Manufacturing Quality: Strict compliance with cGMP standards is essential for APIs used in oncology to prevent impurities that could compromise patient safety.

Regulatory Approval: Source selection depends heavily on regulatory alignments, with APIs meeting stringent standards such as USFDA, EMA, TGA, and other regional approvals.

Capacity and Lead Times: Given the complexity of synthesis and high regulatory thresholds, capacity constraints may influence supply availability. Leading manufacturers typically maintain buffer stocks to ensure steady supply.

Pricing Dynamics: API prices for dacarbazine are influenced by raw material costs, regulatory compliance, manufacturing complexity, and geopolitical factors. International competition tends to stabilize prices but can fluctuate based on regional demand.

Emerging Trends and Future Outlook

The API landscape for SOTRADECOL is evolving, driven by increased demand for oncology medicines and regulatory emphasis on manufacturing transparency. Asian manufacturers, especially Chinese and Indian firms, continue to expand their production capacities, potentially lowering costs and improving supply resilience. However, quality assurance and compliance remain paramount, with clients increasingly preferring suppliers with proven regulatory track records.

Regulatory and Quality Assurance

APIs must meet pharmacopoeial standards such as USP, EP, or JP. Manufacturing facilities must pass audits from global regulators, and APIs need comprehensive documentation, including Certificates of Analysis (CoA), stability data, and impurity profiles.

Conclusion

The supply of high-quality dacarbazine API—key for SOTRADECOL production—comes from a limited pool of reputable manufacturers primarily located in North America, Europe, and Asia. Companies like AstraZeneca, Teva, Jiangsu Hengrui, and Zhejiang Hisun are leading the market, providing reliable sources to pharmaceutical firms globally. Ensuring supply chain resilience involves evaluating each supplier’s regulatory standing, manufacturing capacity, quality systems, and geopolitical stability.

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Key Takeaways

• The primary suppliers of dacarbazine API are AstraZeneca, Teva, Jiangsu Hengrui, and Zhejiang Hisun.
• Asian manufacturers are emerging as significant sources, offering competitive pricing but requiring rigorous quality validation.
• Regulatory compliance and quality assurance are non-negotiable for sourcing APIs for oncology drugs like SOTRADECOL.
• Manufacturing capacity and supply chain stability are critical parameters to consider when selecting an API source.
• The global API market for dacarbazine is competitive but niche, emphasizing the importance of strategic supplier relationships.

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FAQs

1. What are the main regions producing dacarbazine API for SOTRADECOL?
Primarily North America, Europe, and Asia (notably China and India). Asian manufacturers are increasing their share due to cost advantages and capacity expansions.

2. How do regulatory standards influence API sourcing?
APIs must comply with international Good Manufacturing Practices (GMP) and be approved by regulatory authorities like USFDA, EMA, or other regional agencies to ensure safety, efficacy, and quality.

3. Are there risks associated with sourcing dacarbazine API from emerging markets?
Yes. Variability in quality, regulatory approval status, and supply chain stability can pose risks; therefore, thorough audits and documentation are essential.

4. How can pharmaceutical companies assess API quality?
By reviewing Certificates of Analysis, batch records, third-party audits, and ensuring compliance with pharmacopoeial standards (USP, EP, JP).

5. What is the future outlook for dacarbazine API supply?
Supply is expected to remain stable, with Asian manufacturers expanding capacity and improving quality standards. However, regulatory trends will continue to shape the market dynamics.

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References

1. [1] National Center for Biotechnology Information. "Dacarbazine." PubChem Compound Summary.
2. [2] AstraZeneca Annual Reports and Regulatory Disclosures.
3. [3] Teva Pharmaceuticals Official Website: API manufacturing and global supply chain.
4. [4] Jiangsu Hengrui Medicine Co., Ltd. Corporate Publications and Product Brochures.
5. [5] Zhejiang Hisun Pharmaceutical Co., Ltd. Quality Certifications and Market Reports.
6. [6] GlobalData Reports on Oncology API Market, 2022.

Note: This report is designed for informational purposes for business decision-makers and does not replace due diligence or consultation with regulatory and quality assurance experts.