Carbinoxamine Maleate bulk supplier for pharma manufacturers

Carbinoxamine Maleate 4mg, 8mg / 6mg/5ml Suppliers & Bulk Manufacturers

Available Forms: Tablets / Suspension

Available Strengths: 4mg, 8mg / 6mg/5ml

Reference Brands: Karbinal ER (USA), Palgic (USA / EU)

Carbinoxamine Maleate is a first-generation antihistamine used for the treatment of allergic conditions including rhinitis, conjunctivitis, urticaria, and skin allergies. It is available in tablets (4 mg, 8 mg), oral solution/syrup (2–4 mg/5 mL), and extended-release forms.

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Product Description:

Carbinoxamine maleate is a first-generation ethanolamine antihistamine, structurally related to diphenhydramine and sharing its pronounced sedative and anticholinergic profile. It is a potent H1 antagonist with a comparatively long duration of action, which supports twice-daily dosing in immediate-release form and once-daily dosing in the extended-release suspension.

Presentations include immediate-release tablets, an oral solution, and an extended-release suspension formulated with an ion-exchange resin to control release — a more technically demanding formulation than a simple syrup, and one that materially narrows the field of capable manufacturers.

An important regulatory constraint. Carbinoxamine carries a contraindication in children under two years of age. The United States FDA acted against unapproved carbinoxamine-containing products in 2006 following reports of deaths in infants, and approved products carry this restriction explicitly. Any paediatric presentation must reflect that limit in its labelling and product information.

Sourcing notes. The extended-release suspension and the immediate-release tablet are distinct manufacturing propositions; confirm which the quoted plant is actually approved to produce. Carbinoxamine is not registered in every market — it has a stronger presence in the United States than across Europe — so confirm regulatory status in the destination market before beginning a registration file rather than after.

Carbinoxamine Maleate — third party manufacturing & bulk supply

Carbinoxamine Maleate 4mg, 8mg / 6mg/5ml 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

Carbinoxamine Maleate is supplied as Tablets / Suspension — supplied in more than one dosage form, each with its own manufacturing economics, 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 Carbinoxamine Maleate 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

Carbinoxamine maleate is used for the relief of symptoms associated with allergic rhinitis, hay fever, urticaria, and mild allergic skin conditions.

Carbinoxamine maleate is made from the active compound Carbinoxamine, combined with maleic acid to form a stable salt form for oral use.

Trade names include Arbinoxa, Karbinal ER, and Palgic.

Carbinoxamine maleate is marketed by companies such as Tris Pharma, Inc. (Karbinal ER) and Cornerstone Therapeutics (Palgic).

The generic name is Carbinoxamine maleate.

Brand names include Arbinoxa, Karbinal ER, and Palgic.

Carbinoxamine maleate is manufactured by multiple pharmaceutical companies in the USA and other countries, including Tris Pharma and several generic manufacturers approved by the U.S. FDA.