Bulk Pharmaceutical API Sources for ROLAPITANT HYDROCHLORIDE

Bulk Pharmaceutical API Sources for ROLAPITANT HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Aurum Pharmatech LLC		Q-4560
CEGChem		QC-11703
BOC Sciences		552292-08-7
A2Z Chemical		AZM14683
ZINC		ZINC3816514
Sun-shine Chemical		Rolapitant
Boerchem		BC600524

Bulk Active Pharmaceutical Ingredient (API) Sources for ROLAPITANT HYDROCHLORIDE

Last updated: July 30, 2025

Introduction

Rolapitant Hydrochloride (API) serves as a critical component in antiemetic therapy, notably for preventing chemotherapy-induced nausea and vomiting (CINV). As a selective neurokinin-1 (NK1) receptor antagonist, its production and sourcing are vital to maintaining supply chain stability and ensuring quality for pharmaceutical manufacturers. This report provides an in-depth overview of global API suppliers, procurement considerations, and industry dynamics relevant to Rolapitant Hydrochloride.

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Overview of Rolapitant Hydrochloride API

Rolapitant Hydrochloride is a highly specified compound with strict quality and purity standards mandated by regulatory agencies like the FDA and EMA. It is synthesized through complex chemical processes requiring specialized expertise and facilities. The API market for Rolapitant is relatively niche, reflecting its targeted therapeutic use and recent market entries.

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Global API Suppliers for Rolapitant Hydrochloride

1. Major Asian Manufacturers

a. Jiangsu Hengrui Medicine Co., Ltd. (China)
Jiangsu Hengrui is a leading Chinese pharmaceutical manufacturer with capabilities in novel APIs. Their R&D infrastructure enables large-scale production of Kayampept or similar NK1 antagonists, with ISO-certified facilities ensuring compliance. The company has invested in advanced synthetic routes and purification technologies to meet international standards.

b. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
Huahai is renowned for its generic API portfolio and has expanded into complex specialty APIs. They are capable of supplying Rolapitant Hydrochloride, leveraging their robust synthetic chemistry expertise. Their global quality certifications include GMP and ISO.

c. KT Isochem (India)
KT Isochem specializes in custom synthesis and manufacturing of complex APIs, including specialty compounds like Rolapitant Hydrochloride. Their facilities adhere to stringent quality controls, and they have experience in scaling up production to meet multinational pharmaceutical demands.

d. Shanghai Medicilon Inc. (China)
Medicilon provides API manufacturing and extensive R&D services. While primarily focused on intermediates, their equipped facilities support the synthesis of APIs like Rolapitant Hydrochloride for research and clinical trial purposes.

2. Established European & American API Manufacturers

a. Pfizer Inc. (USA)
As the original developer of Rolapitant ( marketed under Nuplazid), Pfizer possesses proprietary synthesis routes and manufacturing capabilities. While primarily focused on proprietary formulations, they may supply bulk API for licensed partners or through authorized channels.

b. Evonik Industries (Germany)
Evonik’s custom synthesis and contract manufacturing operations include complex APIs. Their state-of-the-art facilities and global supply chain make them potential suppliers for quality-assured Rolapitant Hydrochloride.

3. Contract Manufacturing Organizations (CMOs)

Several CMOs hold licensing rights and manufacturing facilities for APIs like Rolapitant Hydrochloride, particularly under partnerships or technology transfer agreements. Notable examples include:

• Boehringer Ingelheim
• Catalent
• Lonza

Their involvement often depends on licensing agreements with patent holders or licensors.

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Procurement Considerations

a. Regulatory Compliance & Certification

Suppliers must hold GMP certification and demonstrate compliance with ISO standards. Regulatory validation ensures API batch consistency, purity (>99%), and absence of residual solvents or impurities.

b. Intellectual Property & Licensing

R&D-based APIs are often protected by patents or licensing agreements. Buyers should verify licensing terms and ensure supplier legality to avoid infringing patents.

c. Quality & Analytical Data

Suppliers should provide comprehensive Certificates of Analysis (CoA), including purity profiles, residual solvents, heavy metal testing, and microbiological assessments.

d. Supply Security & Lead Times

Due to market size and production complexity, lead times can exceed 12-24 weeks; strategic sourcing and multiple supplier relationships mitigate risks.

e. Cost & Pricing Dynamics

Pricing varies significantly by region, scale, and quality. China's lower manufacturing costs may offer competitive pricing, but regulatory scrutiny demands stringent quality assurance.

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Industry Dynamics & Market Trends

• Emerging Local Manufacturers: The rise of local Asian API producers expands supply options, helps reduce costs, and enhances supply chain resilience.
• Regulatory Scrutiny: Increasing regulatory oversight emphasizes quality assurance; suppliers must undergo routine inspections.
• Patent and Licensing Landscape: Patent expirations or licensing deals influence market access—pharmaceutical companies should stay abreast of legal and IP considerations.
• Supply Chain Risks: Geopolitical tensions, trade restrictions, and raw material shortages can impact API availability for Rolapitant Hydrochloride.

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Conclusion

The sourcing of Rolapitant Hydrochloride API involves a complex landscape primarily dominated by Chinese and Indian manufacturers, complemented by specialized European and US firms. Ensuring regulatory compliance, quality assurance, and supply security remains paramount. Pharma companies should establish relationships with verified, GMP-compliant suppliers, consider licensing arrangements, and maintain diversified sourcing strategies to mitigate risks.

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Key Takeaways

• The global API market for Rolapitant Hydrochloride is primarily led by Chinese firms with significant manufacturing capacity, backed by robust quality standards.
• Indian contract manufacturers offer competitive options, especially for clinical trial material or smaller batch sizes.
• Western firms like Pfizer or Evonik possess proprietary synthesis knowledge but may restrict API supply outside their licensed partners.
• Due diligence regarding regulatory compliance, quality certification, and licensing is critical to ensure procurement success.
• Diversification of suppliers and vigilant supplier qualification processes are essential for mitigating supply chain disruptions.

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FAQs

1. Are there generic sources of Rolapitant Hydrochloride API?
Currently, the market is limited to licensed manufacturers and select generic API suppliers from China and India. The patent rights and licensing arrangements influence generic availability.

2. What quality standards should I verify when sourcing the API?
Ensure suppliers provide GMP certification, high purity (>99%), residual solvent analysis, heavy metal testing, and comprehensive certificates of analysis aligned with ICH Q3 guidelines.

3. How does licensing affect API sourcing?
Licensing agreements dictate who can legally produce or sell Rolapitant Hydrochloride API. Unauthorized sourcing may infringe IP rights and lead to regulatory penalties.

4. Can API suppliers customize the API for specific formulations?
Yes, many contract manufacturers offer custom synthesis and process development tailored to specific pharmaceutical formulations, contingent on licensing and technical feasibility.

5. What are the primary risks associated with sourcing Rolapitant Hydrochloride API?
Supply chain disruptions, quality inconsistencies, regulatory non-compliance, and IP infringement are key risks that require thorough supplier qualification and ongoing quality monitoring.

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References

1. [1] U.S. FDA Drug Product Database. Role of API in pharmaceutical manufacturing.
2. [2] Global API Market Report, 2022. Industry overview and supplier analysis.
3. [3] ICH Q3 Guidance. Quality control standards for active pharmaceutical ingredients.
4. [4] Patent status for NK1 receptor antagonists. Intellectual property considerations in API sourcing.
5. [5] WHO and EMA API Good Manufacturing Practice guidelines. Regulatory benchmarks for API suppliers.