Suppliers and packagers for ROZEREM

ROZEREM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782	NDA	Takeda Pharmaceuticals America, Inc.	64764-805-10	100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)	2005-07-22
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782	NDA	Takeda Pharmaceuticals America, Inc.	64764-805-22	6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK	2005-07-22
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782	NDA	Takeda Pharmaceuticals America, Inc.	64764-805-30	30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)	2005-07-22

Suppliers for the Pharmaceutical Drug: ROZEREM

Last updated: July 29, 2025

---

Introduction

Rozerem (ramelteon) occupies a distinctive niche in sleep disorder therapeutics, primarily used for the treatment of insomnia characterized by difficulty in sleep onset. Originally developed and marketed by Takeda Pharmaceuticals, Rozerem’s global supply chain involves multiple suppliers across chemical, manufacturing, and distribution sectors. This article delineates the key suppliers involved in Rozerem’s lifecycle, highlighting their roles, the scope of their contributions, and the dynamics influencing supply stability.

---

Active Pharmaceutical Ingredient (API) Suppliers

The cornerstone of Rozerem’s supply chain is its active pharmaceutical ingredient, ramelteon. The integrity and consistent quality of the API are fundamental to product efficacy and regulatory compliance.

Ramelteon API Manufacturers

1. Traditional Chemical Synthesis Plants
   Historically, Takeda has relied on specialized chemical synthesis firms capable of producing high-purity ramelteon. These facilities are often located in regions with robust pharmaceutical manufacturing infrastructure, such as India, China, and Europe. Suppliers in India, including well-known custom synthesis entities, have played crucial roles, benefitting from India’s developed chemical manufacturing sector and cost advantages.

2. Contract Manufacturing Organizations (CMOs)
   Takeda’s collaborations with CMOs enable scalable production of ramelteon API. These organizations provide fine-tuned processes that ensure API purity exceeding 99%. Specific names are usually proprietary or undisclosed, but industry reports suggest that Takeda uses multiple CMOs to diversify risk and assure supply continuity.

3. Quality and Regulatory Compliance
   Suppliers must adhere to Good Manufacturing Practices (GMP), with rigorous testing protocols to meet pharmacopeial standards (USP, EP). The complexity of ramelteon’s synthesis process—particularly its chirality and stereochemistry—necessitates precise manufacturing controls.

---

Formulation and Finished Dosage Form Suppliers

Beyond API supply, the formulation of Rozerem into capsules involves specialized pharmaceutical manufacturers.

Capsule Manufacturers

• Takeda primarily manages in-house or contracted capsule manufacturers in regions with reliable logistics networks. These contractors provide gelatin or hydroxypropyl methylcellulose (HPMC) capsules, depending on regional preferences and regulatory considerations—such as vegetarian capsules in certain markets.

• Packaging Suppliers: The final product’s packaging, including blister packs and bottles, involves secondary suppliers specializing in pharmaceutical-grade packaging materials that ensure product stability and tamper evidence.

---

Distribution and Logistics

The global distribution of Rozerem involves third-party logistics (3PL) providers who handle warehousing, transportation, and import/export compliance. Critical factors include cold chain management, temperature control, and inventory tracking.

---

Regulatory and Compliance Considerations

The supply chain’s diversity must align with international regulatory standards set by agencies like the FDA, EMA, and PMDA. Suppliers are periodically audited to ensure GMP adherence, and any deviation can impact market access.

---

Strategic Supply Chain Dynamics

• Diversification: Takeda’s use of multiple suppliers for API and formulation components mitigates risks associated with supply disruptions.
• Global Sourcing: The increasing trend toward globalized supply chains highlights regions like India and China as dominant API producers, driven by cost efficiencies.
• Supply Chain Risks: Political instability, regulatory changes, and pandemic-related disruptions have accentuated the need for robust supply chain management.
• Patent and Market Exclusivity: As patent protections lapse or as generic competition emerges, the supply landscape may shift, influencing sourcing strategies.

---

Emerging Trends and Innovation

• Synthetic Process Improvements: Advances in ramelteon synthesis that reduce costs or improve yields can alter supplier selection.
• Bioequivalent Development: Development of generic versions depends on access to original or alternative API suppliers.
• Sustainability Factors: Increasing emphasis on green chemistry practices influences supplier choice, favoring environmentally responsible manufacturing.

---

Conclusion

The supply of Rozerem involves a complex network of chemical suppliers, formulation manufacturers, packaging providers, and logistics experts. The core API supply chain is characterized by high-quality manufacturers capable of meeting stringent global pharmaceutical standards. Companies like Takeda optimize global sourcing strategies, balancing cost-efficiency with risk mitigation. As the sleep aid market evolves, supply chain resilience, regulatory compliance, and technological innovation will remain pivotal to maintaining Rozerem’s market presence.

---

Key Takeaways

• API Suppliers: Dominated by specialized chemical manufacturers in India, China, and Europe, adhering strictly to GMP standards.
• Manufacturing Diversification: Takeda’s multi-supplier approach minimizes supply disruption risks.
• Regulatory Oversight: Continuous auditing and compliance are crucial for maintaining supply chain integrity.
• Global Trends: Cost pressures and sustainability initiatives shape future supplier partnerships.
• Market Dynamics: Patent expirations and generic entrants may shift supply chain configurations.

---

FAQs

1. Who are the primary API suppliers for Ramelteon used in Rozerem?
Major API suppliers include chemical manufacturing organizations in India and China, with Takeda relying on multiple contract manufacturers to ensure quality and supply security.

2. How does Takeda ensure the quality of Ramelteon API across multiple suppliers?
Takeda enforces stringent GMP compliance, conducts regular audits, and mandates detailed quality testing to ensure consistency and regulatory adherence.

3. Are there emerging competitors or alternative suppliers for Ramelteon API?
While Takeda has secured its supply chain, potential entrants include other regional manufacturers expanding capabilities in Asia, especially as generic development accelerates.

4. How has the COVID-19 pandemic affected Rozerem’s supply chain?
Disruptions in manufacturing and logistics prompted diversification of API sources and increased inventory buffers to maintain uninterrupted supply.

5. What future trends could impact the suppliers for Rozerem?
Innovation in synthesis methods, regulatory changes, and sustainability initiatives are poised to influence supplier selection and partnership strategies moving forward.

---

References

1. [1] Takeda Pharmaceuticals, Rozerem (ramelteon) prescribing information.
2. [2] US Pharmacopeia and European Pharmacopoeia specifications for ramelteon.
3. [3] Industry reports on pharmaceutical manufacturing in India and China.
4. [4] Regulatory guidelines from FDA, EMA, and PMDA pertaining to API manufacturing and quality standards.
5. [5] Market analysis reports on sleep disorder therapeutics and supply chain risks.