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.	64764-805-30	30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)	2005-07-22

Who Supplies Rozerem (Ramelteon) and What’s Known About the Supply Chain

Last updated: April 26, 2026

Rozerem is the brand name for ramelteon, a melatonin receptor agonist. Public-facing “supplier” information is fragmented by jurisdiction because the marketed product is sold through different distributors and licensed manufacturers depending on market, packaging configuration, and regulatory pathway. Based on publicly available label and regulatory artifact conventions, “supply” breaks into three practical buckets: (1) marketing authorization holder / brand owner, (2) drug-substance and drug-product manufacturing, and (3) logistics/distribution. The only widely stable identifier across these buckets is the brand authorization and its controlled distribution channels.

Who is the brand owner for Rozerem?

Rozerem (ramelteon) is marketed by Takeda. The US prescribing information identifies Takeda as the marketing authorization entity on the label.

Jurisdiction	Brand owner / marketer (as shown on labeling)	Evidence
United States	Takeda	Rozerem prescribing information lists Takeda as the holder/publisher for the US label. [1]

Which companies manufacture Rozerem drug product?

Rozerem is a prescription small-molecule tablet. In US labeling, the most consistent manufacturing visibility comes from the “Manufactured for” / “Distributed by” style sections on the prescribing information and from inspections tied to the application and site registration. For Rozerem, the prescribing information is the primary public artifact that ties a specific named entity to manufacturing or distribution on the finished dose label. That label convention is the practical way to identify the supplier for the commercial product, not the underlying upstream excipient or API vendors.

US public label artifact: the prescribing information provides the finished-dose label entity (manufactured for and/or distributed by) used for regulatory labeling in the US. [1]

Who supplies the API (ramelteon)?

API supplier disclosure is typically limited in public prescribing information; API vendor names usually do not appear on the US carton/PI in a way that is consistent across time. For ramelteon, the stable, public, and investable path to identify API supply is the regulatory listing of the finished dose manufacturer(s) and the DMF linkage in jurisdictions that publish or index DMFs. Public procurement databases and periodic import records can also surface API and intermediate sources, but those are not reliably tied to ramelteon without jurisdiction-specific data.

Because your request is “suppliers for the pharmaceutical drug: rozerem,” the only supplier data that can be stated cleanly from broadly accessible public labeling is the brand marketer and the labeled finished-dose manufacturing/distribution entity. Upstream API suppliers are not deterministically public from the US label alone.

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What suppliers exist in practice for Rozerem? (Supply-chain map)

1) Brand marketer (commercial responsibility)

• Takeda is the brand marketer shown on US Rozerem labeling. [1]

2) Finished-dose manufacturer and label-distribution entity

• The Rozerem prescribing information lists the entity that manufactures for and/or distributes the product in the US labeling chain. [1]

3) Distribution network

• Finished-dose products are distributed through authorized wholesalers and specialty channels. This typically changes by market and time, and individual distributor names are not consistently published on the core prescribing information. The stable distribution control is the labeled distributor and the authorized network under it. [1]

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Rozerem label references used to identify suppliers

For supplier diligence, the Rozerem package insert is the canonical document used by commercial buyers and auditors to anchor:

• the marketing authorization entity
• the finished-dose manufacturer/distributor naming
• the contact and label responsibility

Primary supplier anchor (US):

• Rozerem prescribing information (US) identifies Takeda and includes the label entity information used for distribution/manufacturing responsibilities in the US market. [1]

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Key Takeaways

• Takeda is the brand marketer for Rozerem (ramelteon) in the US labeling. [1]
• The finished-dose manufacturing/distribution supplier is identifiable from the Rozerem prescribing information’s label entity sections. [1]
• API supplier names for ramelteon are not deterministically disclosed in the core prescribing information; they require DMF or jurisdiction-specific regulatory indexing rather than the label.

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FAQs

1) Who owns the Rozerem brand?
Takeda is shown as the marketer/label entity for Rozerem in US prescribing information. [1]

2) Can the API supplier be confirmed from the Rozerem label?
No. The Rozerem prescribing information does not provide a deterministic, stable public list of ramelteon API suppliers; it is primarily focused on brand/finished-dose labeling responsibilities. [1]

3) Where does one find the finished-dose manufacturer/distributor name for Rozerem?
In the Rozerem prescribing information sections that state who the product is manufactured/distributed for in the labeled US chain. [1]

4) Do Rozerem suppliers differ by country?
Yes. Finished-dose manufacturing and distribution entities are often market-specific even when the active ingredient is the same, because regulatory and packaging requirements differ. [1]

5) What is the most reliable document for supplier identification?
The Rozerem prescribing information is the most reliable single public artifact for brand-marketer and labeled manufacturing/distribution entity naming. [1]

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References

[1] Takeda Pharmaceuticals U.S.A., Inc. Rozerem (ramelteon) prescribing information. United States.