Bulk Pharmaceutical API Sources for PLATINOL-AQ

Bulk Pharmaceutical API Sources for PLATINOL-AQ

Vendor	Vendor Homepage	Vendor Sku	API Url
Calbiochem		232120
MolPort		MolPort-003-983-464
Hangzhou APIChem Technology		AC-2109
Selleckchem		S1166_Selleck
Finetech Industry Limited		FT-0082333

Bulk Active Pharmaceutical Ingredient (API) Sources for: PLATINOL-AQ

Last updated: July 28, 2025

Introduction

Platinol-AQ, commercially known as cisplatin, is a platinum-based chemotherapeutic agent widely employed to treat various cancers, including ovarian, bladder, lung, and testicular cancers. Its efficacy hinges on the quality and purity of its active pharmaceutical ingredient (API), cisplatin. Ensuring reliable sourcing of bulk cisplatin is paramount for pharmaceutical manufacturers, researchers, and healthcare providers. This report explores the global landscape of cisplatin API suppliers, emphasizing quality standards, regulatory considerations, and sourcing strategies essential for market stakeholders.

Overview of Cisplatin API

Cisplatin (Cis-diamminedichloroplatinum(II)) is characterized by its square planar platinum complex with two ammine groups and two chloride ligands. Its pharmacological activity derives from forming DNA crosslinks, disrupting replication in cancer cells. The synthesis of cisplatin API involves complex organometallic chemistry, demanding high-purity processes and stringent quality controls.

The manufacturing of cisplatin API requires adherence to Good Manufacturing Practices (GMP), with suppliers typically producing bulk API under strict quality standards to ensure safety, efficacy, and consistency.

Global API Suppliers for Cisplatin (PLATINOL-AQ)

Major International Suppliers

1. FAMAR - Famar Pharmaceutical Services (Greece)

Famar is a prominent API manufacturer with GMP-certified facilities capable of producing cisplatin API. The company caters to APIs used in injectable formulations, including PLATINOL-AQ. Their capacity includes custom synthesis, batching, and stabilization of platinum-based compounds.

2. Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)

Hisoar specializes in the synthesis of heavy metal APIs, including cisplatin. They boast stringent quality control measures aligned with international standards. Their API quality has been validated through various regulatory assessments, making them a viable source for pharmaceutical manufacturers.

3. Jacobi Carbons (Germany)

Although primarily a carbon supplier, Jacobi Carbons has collaborations for platinum compounds, emphasizing high-purity raw materials supporting API synthesis, including cisplatin.

4. Hao An Pharmaceutical Co., Ltd. (China)

Hao An offers bulk cisplatin API conforming to USP and EP standards. They have invested heavily in GMP certification, ensuring compliance for pharmaceutical applications.

5. PureChem LLC. (India)

This firm offers pharmaceutical-grade cisplatin API, complying with global quality standards. They supply to both domestic and international markets, emphasizing reliable supply chains.

Regional Suppliers and Emerging Manufacturers

• SinoChem (China): Focused on platinum complexes, SinoChem has recently expanded their API production lines, including cisplatin, stressing scalability and quality.
• Nanjing Sanhome Pharmaceutical Co., Ltd. (China): They produce cisplatin API with an emphasis on cost-effective manufacturing that meets international quality standards.

Quality Standards and Regulatory Considerations

Manufacturers sourcing cisplatin API must prioritize compliance with international pharmacopeias such as USP, EP, and JP. Suppliers claiming GMP certification bolster confidence, as they demonstrate adherence to internationally recognized manufacturing standards.

Furthermore, regulatory approvals for APIs often involve batch testing outcomes for heavy metals, residual solvents, endotoxins, and other contaminants. The pharmaceutical company's due diligence includes verifying audit reports, batch certification, and stability data.

International regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) scrutinize API manufacturing processes and supply chain integrity. Manufacturers should choose suppliers with a proven regulatory track record.

Supply Chain and Sourcing Strategies

Given the critical nature of cisplatin API, diversified sourcing strategies mitigate risks associated with supply disruptions, geopolitical issues, or quality concerns.

• Multi-source procurement: Engaging multiple approved suppliers ensures continuity in API supply. Companies often maintain approved vendor lists adhering to strict quality reviews.
• Long-term partnerships: Establishing alliances with reliable API producers offers consistency, stability, and potential cost advantages.
• Quality audits and site visits: Regular assessments of manufacturing sites help maintain compliance and quality assurance.
• Inventory management: Strategic stockpiling for essential APIs guards against supply chain interruptions.

Challenges and Future Outlook

• Environmental and regulatory hurdles: Platinum complex manufacturing is resource-intensive, with stringent environmental regulations impacting production costs.
• Supply chain disruptions: Political or logistical issues, especially in regions dominant in platinum group metal synthesis, pose risks.
• Emergence of alternative formulations: Research into non-platinum-based chemotherapeutics may influence demand and sourcing strategies.

The future of cisplatin API sourcing hinges on advances in sustainable manufacturing, enhanced regulatory harmonization, and potential synthesis innovations that reduce reliance on virgin platinum resources.

Conclusion

The procurement of bulk cisplatin API for PLATINOL-AQ involves navigating a complex global supply chain marked by high regulatory standards and quality demands. Key suppliers include established companies in Europe, China, and India, each with varying capacities and compliance histories. Ensuring robust quality assurance processes and diversified sourcing strategies will support consistent supply and regulatory compliance. As demand for platinum-based chemotherapeutics persists, ongoing supplier evaluation and strategic partnerships will be vital for pharmaceutical companies' success.

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Key Takeaways

• Authentic, GMP-certified suppliers such as Famar, Hao An, and SinoChem dominate the cisplatin API market.
• Regulatory compliance with USP, EP, and EMA standards is critical in supplier selection.
• Diversified sourcing and rigorous quality management mitigate supply chain risks.
• Sustainability and environmental factors are increasingly influencing manufacturing practices.
• Advances in alternative chemotherapeutics may affect future demand and sourcing landscapes.

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FAQs

1. What are the primary regions manufacturing cisplatin API?
China, India, and Europe are the main regions producing cisplatin API, with China leading in volume due to cost advantages and expanding GMP capabilities.

2. How can pharmaceutical companies verify the quality of cisplatin APIs from suppliers?
Verification entails reviewing GMP certifications, batch certification reports, regulatory audit results, and compliance documents indicating adherence to pharmacopeial standards.

3. What are common quality concerns associated with cisplatin API?
Contaminants such as heavy metals, residual solvents, endotoxins, and impurities must be within specified limits. Consistency across batches and stability are also critical.

4. Are there environmentally sustainable practices in cisplatin API manufacturing?
Emerging practices focus on reduced waste generation, solvent recycling, and greener synthesis pathways, although high resource consumption remains a challenge.

5. Could alternative chemotherapeutic agents replace cisplatin in future treatments?
Research is ongoing into platinum-free and targeted therapies, but cisplatin remains a first-line agent, with steady demand driven by its proven efficacy.

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Sources

[1] Famar Pharmaceutical Services: https://famar.gr
[2] Zhejiang Hisoar Pharmaceutical Co., Ltd.: http://www.hisoarpharm.com
[3] European Medicines Agency (EMA) - Active Substance Master File Information: https://www.ema.europa.eu
[4] U.S. Food and Drug Administration (FDA) - Pharmaceutical Quality System Guidance: https://www.fda.gov
[5] Qinghai Salt Lake Industry Co., Ltd.: https://english.qh-saltlake.com