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Ramelteon bulk supplier for pharma manufacturers

Ramelteon Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 8 mg

Reference Brands: Rozerem (USA)

Category: Neurology

Ramelteon is available in Tablets and strengths such as 8 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Ramelteon is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Ramelteon can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Ramelteon is a melatonin receptor agonist used for the treatment of insomnia, specifically in adults who experience difficulty with sleep onset. It is marketed under the brand name Rozerem and acts by selectively binding to MT1 and MT2 melatonin receptors in the suprachiasmatic nucleus of the brain, the region responsible for regulating the sleep–wake cycle. By mimicking the natural action of endogenous melatonin, ramelteon helps promote the initiation of sleep without exerting sedative, anxiolytic, or muscle-relaxant effects.

Clinical studies have demonstrated that ramelteon significantly reduces latency to persistent sleep, meaning it shortens the time required to fall asleep. In controlled trials, an 8 mg dose showed a measurable reduction in sleep onset time compared to placebo, with consistent effects observed during early treatment. Meta-analyses of longer-term use indicate modest improvements in subjective sleep latency, sleep quality, and sleep efficiency, although effects on total sleep time are variable.

Ramelteon is approved for long-term use and is considered distinct from benzodiazepines and non-benzodiazepine hypnotics, as it does not cause dependence, tolerance, or rebound insomnia. Its favorable safety profile makes it a suitab

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Frequently Asked Questions

Ramelteon is used for the treatment of insomnia in adults, specifically for difficulty in falling asleep (sleep-onset insomnia).

Ramelteon is a synthetically produced melatonin receptor agonist designed to mimic the action of endogenous melatonin on MT1 and MT2 receptors.

The trade name of Ramelteon is Rozerem.

Rozerem was originally developed and marketed by Takeda Pharmaceutical Company.

The generic name of Ramelteon is ramelteon.

The brand name of Ramelteon is Rozerem.

Ramelteon finished dosage forms are manufactured by different pharmaceutical manufacturers depending on the market, with original branded production associated with Takeda-approved manufacturing facilities.

Yes, Ramelteon is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Ramelteon is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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