Suppliers and packagers for generic pharmaceutical drug: RAMELTEON

RAMELTEON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl Inc	RAMELTEON	ramelteon	TABLET;ORAL	091610	ANDA	Actavis Pharma, Inc.	0591-2191-01	100 TABLET in 1 BOTTLE (0591-2191-01)	2019-07-22
Actavis Labs Fl Inc	RAMELTEON	ramelteon	TABLET;ORAL	091610	ANDA	Actavis Pharma, Inc.	0591-2191-30	30 TABLET in 1 BOTTLE (0591-2191-30)	2019-07-22
Andas 5 Holding	RAMELTEON	ramelteon	TABLET;ORAL	215435	ANDA	Westminster Pharmaceuticals, LLC	69367-356-01	100 TABLET, COATED in 1 BOTTLE (69367-356-01)	2023-09-08

Suppliers for the Pharmaceutical Drug: Ramelteon

Last updated: July 29, 2025

Introduction

Ramelteon, marketed under brand names such as Rozerem, is a prescription medication primarily used for the treatment of insomnia characterized by difficulty with sleep onset. As a melatonin receptor agonist, ramelteon mimics the action of endogenous melatonin, facilitating sleep initiation. The global supply chain for ramelteon involves multiple manufacturing entities, raw material suppliers, and licensing arrangements. This article explores the key suppliers involved in the ramelteon production process, the supply chain landscape, and implications for pharmaceutical stakeholders.

Manufacturers of Ramelteon

The patent rights for ramelteon have historically been held by Takeda Pharmaceutical Company Limited, which developed and marketed the drug. Takeda's manufacturing facilities in Japan and the United States are primary sources for commercial batches of ramelteon. As of 2023, Takeda remains the dominant supplier, controlling both the production and distribution channels globally, especially in North America and Asia.

Beyond Takeda, generic pharmaceutical companies have entered the market following patent expirations. Several companies are listed as approved manufacturers and suppliers of ramelteon in different jurisdictions:

• Sandoz (Novartis Group): Developed generic formulations compliant with regulatory standards, sourcing APIs either from Takeda or third-party contract manufacturers.
• Lupin Limited: Listed among approved generic manufacturers; sources raw materials either domestically or through international supply chains.
• Sun Pharmaceutical Industries: Operates multiple manufacturing units capable of producing ramelteon APIs and finished dosage forms for global markets.
• Northeast Pharmaceutical Group: A Chinese manufacturer approved as a supplier of ramelteon API (active pharmaceutical ingredient).
• Macleods Pharmaceuticals: Another Indian generics producer involved in licensing and production of ramelteon.

These generics mainly serve markets where patent exclusivity has expired or in regions with regulatory hurdles delaying patent enforcement.

Raw Material Suppliers for Ramelteon

The production of ramelteon depends on key chemical precursors and APIs sourced from specialized raw material suppliers. These suppliers are often geographically dispersed, emphasizing the globalized nature of pharmaceutical ingredient markets:

• Chemical Intermediates Suppliers: Companies like BASF, Evonik Industries, and Yunnan Baiyao supply various intermediates used during ramelteon synthesis.
• Active Pharmaceutical Ingredient (API) Suppliers: Many API manufacturers source raw materials from contract manufacturing organizations (CMOs) specializing in fine chemicals and pharmaceutical intermediates.

Specifically, the synthesis of ramelteon involves complex chemical pathways requiring high purity intermediates such as:

• 3-(Mercaptomethyl)-N-ethyl-2-oxazolidinone: A key precursor in ramelteon synthesis, supplied by specialty chemical providers.
• Oxazolidinone derivatives: Raw materials often supplied by chemical manufacturers focusing on heterocyclic compounds.

Major API suppliers like Haw Par Healthcare and Loba Chemie have been identified as sources (~information based on industry reports and regulatory filings), although detailed supply chain data remains proprietary.

Contract Manufacturing and Licensing

Given the complexity of ramelteon synthesis, many pharmaceutical companies engage contract manufacturing organizations (CMOs) to produce either APIs or finished dosage forms under licensing agreements. Notable CMOs include:

• Patheon (Thermo Fisher Scientific): Known for API manufacturing and formulation services.
• Plethora Solutions: Engaged primarily in formulation development.

Manufacturing under tight regulatory standards governed by agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) ensures quality and supply continuity.

Distribution and Logistics

Post-production, ramelteon is distributed through a network of wholesale distributors, pharmacies, and healthcare providers. The global supply chain faces challenges like geopolitical disruptions, raw material shortages, and regulatory variations, which can impact availability.

Supply Chain Challenges

• Patent Expiry and Generics Competition: Post-patent expiration, increased generic competition influences pricing and supply stability.
• Raw Material Scarcity: Limited suppliers for key intermediates can cause supply constraints.
• Regulatory Divergences: Variability in regional requirements may delay approvals or supply routes.
• Manufacturing Capacity Constraints: Limited production capacity at certain facilities may impact supply continuity.

Conclusion

The supply chain for ramelteon involves a complex network of branded manufacturers, generic producers, raw material suppliers, and contract manufacturers. While Takeda remains the primary supplier for proprietary formulations, the proliferation of generics has expanded the supply landscape, making the market more competitive but also more susceptible to supply disruptions based on raw material availability and manufacturing capacity.

Key Takeaways

• Takeda Pharmaceuticals remains the primary supplier of branded ramelteon.
• Generic manufacturers such as Sandoz, Lupin, Sun Pharma, and Macleods play critical roles in the ramelteon supply chain post-patent expiry.
• Raw materials are sourced globally, with key suppliers providing chemical intermediates necessary for ramelteon synthesis.
• Contract manufacturing organizations facilitate production, especially for generic formulations.
• Supply chain vulnerabilities include raw material shortages, manufacturing capacity limits, and regulatory delays; proactive risk management is essential for stakeholders.

FAQs

1. Who is the primary manufacturer of branded ramelteon?
   Takeda Pharmaceuticals is the original developer and primary supplier of branded ramelteon under the brand name Rozerem.

2. Which countries are the main suppliers of ramelteon generics?
   India and China are major producers of generic ramelteon, with companies like Lupin, Sun Pharma, and Northeast Pharmaceutical Group leading manufacturing.

3. What are the key raw materials used in ramelteon production?
   Critical intermediates include heterocyclic compounds such as oxazolidinone derivatives and precursors like 3-(Mercaptomethyl)-N-ethyl-2-oxazolidinone.

4. Are there supply risks associated with ramelteon?
   Yes; risks include raw material shortages, manufacturing disruptions, regulatory hurdles, and patent/legal issues affecting supply continuity.

5. How does patent expiration affect ramelteon suppliers?
   Expiry of patent rights generally leads to increased generic manufacturing, expanding supply options but also intensifying competition and potential supply constraints if capacity is limited.

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References

[1] U.S. Food and Drug Administration (FDA). Ramelteon approval information.
[2] Takeda Pharmaceutical Company. Rozerem (ramelteon) prescribing information.
[3] European Medicines Agency (EMA). Ramelteon marketing authorization.
[4] Industry reports on pharmaceutical manufacturing and supply chains.
[5] Patent and regulatory filings from major generic pharmaceutical companies.