Chlorpheniramine Maleate / Codeine bulk supplier for pharma manufacturers

Chlorpheniramine Maleate / Codeine Suppliers & Bulk Manufacturers

Available Forms: Extended-Release Tablets

Available Strengths: 54.3 mg of codeine; 8 mg of chlorpheniramine maleate

Reference Brands: Tuxarin ER (US)

Codeine 54.3 mg and chlorpheniramine maleate 8 mg extended-release tablets, a twice-daily opioid cough suppressant and antihistamine for adults. For licensed importers holding controlled drug permits.

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Product Description:

These extended-release tablets combine codeine phosphate 54.3 mg, an opioid cough suppressant acting on the brainstem cough centre, with chlorpheniramine maleate 8 mg, a sedating H1 antihistamine. Codeine works largely through conversion to morphine by the liver enzyme CYP2D6. The release-controlled matrix spreads both drugs over about 12 hours, so one tablet is taken twice daily. The tablet must be swallowed whole; crushing or chewing it would release the full opioid dose at once.

In the reference labelling it relieves cough and the nasal and eye symptoms of upper respiratory allergy or the common cold in adults; US regulators restrict opioid cough products to adults aged 18 and over. Codeine is contraindicated in children under 12, and after tonsil or adenoid surgery in young people, because ultra-rapid CYP2D6 metabolisers can form dangerous morphine levels. Respiratory depression is the main risk, made worse by benzodiazepines, alcohol and other depressants. Dependence and misuse occur with repeated use, and drowsiness rules out driving.

Sourcing notes. Codeine is a controlled medicine in many countries, and this product moves only when the importer holds the required import permit and the exporter the matching export authorisation. Some markets restrict codeine combinations to prescription-only status or have withdrawn them. Expect a CTD dossier with dissolution profiles showing that the extended release holds up, including in the presence of alcohol. Tablets are packed in blisters or child-resistant bottles. Each batch needs a CoA; ask also for the GMP certificate and a CoPP. State strength, pack size and the permit numbers you hold.

Chlorpheniramine Maleate / Codeine — third party manufacturing & bulk supply

Chlorpheniramine Maleate / Codeine 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

Chlorpheniramine Maleate / Codeine is supplied as Extended-Release Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. 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 Chlorpheniramine Maleate / Codeine 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

Chlorpheniramine maleate and codeine is a combination medication used to relieve symptoms associated with cough, cold, and allergic conditions. It helps reduce coughing, sneezing, runny nose, watery eyes, and throat irritation caused by allergies or respiratory infections. The combination is often prescribed for the symptomatic treatment of cough and upper respiratory tract irritation.

This medicine contains two active ingredients: chlorpheniramine maleate and codeine phosphate. Chlorpheniramine maleate is an antihistamine that blocks histamine receptors to reduce allergy symptoms, while codeine is an opioid antitussive that acts on the cough center in the brain to suppress coughing.

Common trade names for chlorpheniramine maleate and codeine combinations include Tuzistra XR, TussiCaps, and several regional cough syrup brands marketed in different countries.

Chlorpheniramine maleate and codeine combination products are manufactured by various pharmaceutical companies worldwide. For example, Tuzistra XR is marketed by Vernalis Therapeutics in the United States, while many other manufacturers produce generic versions in global markets.

The generic name is chlorpheniramine maleate and codeine phosphate.

Brand names available in different regions include Tuzistra XR (USA), TussiCaps (USA), Codipront (Europe), and several cough and cold combination brands marketed in Asia and other emerging markets.

Chlorpheniramine maleate and codeine combination products are manufactured by pharmaceutical companies in multiple regions, including the United States, Europe, India, and other regulated and emerging pharmaceutical manufacturing markets.