Bulk Pharmaceutical API Sources for ROZEREM

Bulk Pharmaceutical API Sources for ROZEREM

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-751
Hangzhou APIChem Technology		AC-5275
Amadis Chemical		A813859
AKos Consulting & Solutions		AKOS015895741
MedChemexpress MCE		HY-A0014

Bulk Active Pharmaceutical Ingredient (API) Sources for Rozerem (Ramelteon)

Last updated: July 27, 2025

Introduction

Rozerem (generic: Ramelteon) is a prescription drug primarily used for the treatment of insomnia characterized by difficulty with sleep onset. Approved by the FDA in 2005, Ramelteon acts as a selective melatonin receptor agonist, targeting melatonin receptors MT1 and MT2 to regulate circadian rhythms. As a critical component in the manufacturing of Rozerem, the procurement of high-quality bulk Active Pharmaceutical Ingredient (API) is vital for pharmaceutical companies to ensure product efficacy, safety, and regulatory compliance.

The global API supply chain has expanded markedly, with numerous sources capable of providing Ramelteon’s key raw material in bulk. This report details prominent API manufacturers, discusses supply considerations, and highlights industry trends relevant for stakeholders involved in sourcing Ramelteon API.

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Overview of Ramelteon API

Ramelteon’s chemical name is N-[2-(1,6,9,10-tetramethyldecahydrochromen-2-yl)ethyl]-N-methyl-2-propionamido-benzamide, with a molecular formula of C16H21N3O2 and a molecular weight of approximately 286.36 g/mol. The API is synthesized through multi-step processes involving complex organic chemistry techniques that demand high manufacturing standards.

The API's purity must meet stringent pharmacopoeial requirements, including assays, impurities, residual solvents, and stability parameters set by regulatory agencies such as the FDA and EMA.

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Key API Manufacturers for Ramelteon

1. Catalent (USA/Europe/Asia)

Catalent is a leading global contract development and manufacturing organization (CDMO) specializing in pharmaceutical development, formulation, and active ingredient production. Their extensive manufacturing facilities in the USA, Europe, and Asia have the capacity and expertise to supply Ramelteon API conforming to GMP standards.

• Capabilities: Large-scale bulk API manufacturing, custom synthesis, and broad regulatory support.
• Certifications: GMP, ISO 9001, and certified for multiple international markets.
• Supply reliability: High due to diversified production sites and rigorous quality controls.

2. Zhejiang Huahai Pharmaceutical (China)

Huahai Pharmaceutical is one of China’s largest API manufacturers, with a broad portfolio covering cardiovascular, central nervous system, and hormonal APIs.

• API production: Ramelteon synthesis aligns with global quality standards, with large-volume batch production.
• Regulatory compliance: Holds CFR Part 210/211 certificates; has experience supplying APIs to Western markets.
• Market position: Competitive pricing and capacity advantages make Huahai a preferred supplier for many global firms.

3. Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui is known for producing high-quality active pharmaceutical ingredients, including complex molecules like Ramelteon.

• Manufacturing: Uses advanced synthesis techniques and strict quality assurance.
• Market reach: Supplies to North American, European, and Asian markets.
• Regulatory status: Ongoing efforts for GMP certifications and global audits enhance credibility.

4. Wuxi AppTec (China/USA)

Wuxi AppTec offers extensive custom synthesis capabilities, including API supply of complex compounds such as Ramelteon.

• Specialization: Focuses on high-tier pharmaceutical clients requiring tailored manufacturing processes.
• Quality control: Adheres to stringent quality standards, including FDA and EMA certifications.
• Supply chain: Ensures continuous supply through multi-site operations.

5. Piramal Enterprises (India)

Piramal is a strategic global API manufacturer with a diverse portfolio, including CNS-related APIs.

• Manufacturing expertise: Known for robustness in complex API synthesis, capable of scaling Ramelteon production.
• Certification: GMP-certified; supplies to global pharma firms.
• Cost efficiency: Competitive pricing for bulk procurement.

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Supply Chain and Industry Trends

Expansion of API Manufacturing in Asia

The Asia-Pacific region dominates global API manufacturing due to lower costs, expanding capacities, and technological advancements. China and India collectively produce the majority of pharmaceutical ingredients, including Ramelteon.

Increasing Regulatory Scrutiny

As countries intensify GMP compliance and quality standards, API manufacturers seek to achieve and maintain certifications such as FDA’s cGMP, EMA’s Good Manufacturing Practice (GMP), and others. This trend enhances supply chain reliability but may elevate costs and lead times.

Vertical Integration and Strategic Sourcing

Many pharmaceutical companies pursue vertical integration, developing in-house API synthesis capabilities or establishing long-term contracts with reputable API producers. This approach mitigates supply disruptions and ensures consistent quality.

Emergence of Flexible Contract Manufacturing

Contract manufacturing organizations (CMOs) offering contract synthesis and scale-up capabilities provide flexible sourcing options, reducing risk and fostering innovation. Such partnerships help accommodate fluctuating demand for Rozerem.

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Regulatory and Quality Considerations

Sourcing Ramelteon API entails strict adherence to regulatory standards:

• GMP compliance: Ensures raw API quality aligns with pharmacopoeial standards (USP, EP).
• Impurity profiling: Suppliers must demonstrate consistent impurity profiles within acceptable limits.
• Stability data: Reliable long-term stability data assures API quality.
• Traceability and audit readiness: Suppliers should maintain detailed documentation for regulatory audits.

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Conclusion

The procurement of bulk Ramelteon API involves evaluating multiple global manufacturers capable of delivering high-quality, compliant products. Leading suppliers like Catalent, Huahai Pharmaceutical, Jiangsu Hengrui, Wuxi AppTec, and Piramal Enterprises dominate the landscape, thanks to their technological capabilities, regulatory adherence, and manufacturing scale. As the industry advances, regional manufacturing expansion, stricter regulatory oversight, and strategic sourcing models will continue to shape the API supply chain for Ramelteon.

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Key Takeaways

• Global supplier diversity: Key API sources include North American, Chinese, and Indian manufacturers, each with unique strengths in capacity, cost, and compliance.
• Regulatory compliance: Ensuring suppliers meet GMP and pharmacopoeial standards is critical to maintaining product quality.
• Supply chain resilience: Diversification of API sources and strategic partnerships mitigate risks of disruption.
• Industry trends: Growing Asian manufacturing capacity, regulatory scrutiny, and flexible contract manufacturing shape the API sourcing landscape.
• Due diligence: Comprehensive vendor qualification and audits are essential before engaging with API suppliers for Ramelteon.

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FAQs

1. What are the main criteria for selecting a Ramelteon API supplier?
Quality compliance (GMP certification), supply capacity, cost efficiency, regulatory track record, and stability of the production process.

2. Are Chinese API manufacturers reliable for Ramelteon?
Yes. Several Chinese companies like Zhejiang Huahai and Jiangsu Hengrui have established GMP-compliant facilities and supply agreements with Western pharmaceutical firms.

3. How does regulatory compliance impact API sourcing?
Non-compliance increases regulatory risk, delays, and potential product recalls. Choosing suppliers with verified GMP certifications and proven quality records is essential.

4. Is regional sourcing recommended for critical APIs like Ramelteon?
Diversifying sources regionally reduces dependency on a single supplier or geographic location, thereby enhancing supply chain resilience.

5. Can custom synthesis improve API quality or availability?
Yes. Custom synthesis allows for tailored processes, higher purity, and scalability, which can improve consistency and reduce supply risks.

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Sources:
[1] FDA Drug Database, Rozerem (Ramelteon) Approval, 2005
[2] European Pharmacopoeia Monograph on Ramelteon API
[3] Industry reports on API manufacturing capacity and trends
[4] Company disclosures and certifications from Catalent, Huahai, Hengrui, Wuxi AppTec, and Piramal