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Chloral Hydrate bulk supplier for pharma manufacturers

Chloral Hydrate 500 mg/5 mL Suppliers & Bulk Manufacturers

Available Forms: Oral solution

Available Strengths: 500 mg/5 mL

Reference Brands: Welldorm Elixir (EU/UK)

Category: Neurology

Chloral Hydrate is a non-benzodiazepine sedative and hypnotic used for the short-term treatment of severe insomnia when other therapies are ineffective. It works by being metabolized to trichloroethanol, which enhances GABA activity in the central nervous system, producing sedation and promoting sleep. It is typically administered as an oral solution.

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Product Description:

Chloral hydrate is one of the oldest synthetic sedatives, in use since the 1860s. It is a prodrug: alcohol dehydrogenase rapidly reduces it to trichloroethanol, which acts at the GABA-A receptor much like a barbiturate. Its surviving role is paediatric sedation for painless procedures such as EEG and imaging, and short-term treatment of severe insomnia where other options have failed.

It has a narrow margin between sedative and toxic doses. Overdose causes cardiac arrhythmias — trichloroethanol sensitises the myocardium to catecholamines — together with respiratory depression and gastric irritation. Ethanol and chloral hydrate inhibit each other's metabolism, which is the pharmacology behind the historic "Mickey Finn". Tolerance develops within about two weeks, so it is not a long-term hypnotic, and it is corrosive to mucosa unless diluted.

Sourcing notes. Regulatory status varies more than for almost any other sedative. In the US unapproved chloral hydrate products were removed from the market in 2012 and it is a Schedule IV controlled substance; in the UK it remains available for paediatric sedation, largely as an oral solution. Several markets supply it only as an extemporaneous or specials product. The solution is bitter and irritant, so flavouring and dilution form part of the specification, and chloral hydrate raw material itself is controlled in some jurisdictions.

Chloral Hydrate — third party manufacturing & bulk supply

Chloral Hydrate 500 mg/5 mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Chloral Hydrate is supplied as Oral solution — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Chloral Hydrate listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Chloral Hydrate is listed as Oral solution in 500 mg/5 mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Chloral Hydrate is referenced against Welldorm Elixir (EU/UK). Reference brands are shown for identification only and remain the property of their respective trademark owners.

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