Varenicline bulk supplier for pharma manufacturers

Varenicline 0.5 mg, 1 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 0.5 mg, 1 mg

Reference Brands: Chantix (USA), Champix(EU/UK)

Varenicline tartrate film-coated tablets, 0.5 mg and 1 mg, a prescription smoking cessation medicine sold as starter and maintenance packs. For importers, distributors, hospitals and public health tender buyers.

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Product Description:

Varenicline is a smoking cessation medicine, supplied as the tartrate salt in film-coated tablets of 0.5 mg and 1 mg. As a partial agonist at the alpha-4 beta-2 nicotinic receptor, it stimulates the receptor enough to ease craving and withdrawal while stopping nicotine from binding, so a cigarette feels less rewarding. Two strengths exist because treatment starts with a titration, so many markets sell a starter pack holding both and a separate 1 mg maintenance pack.

The patient sets a quit date and usually starts tablets one to two weeks before it. Dosing rises from 0.5 mg once daily to 0.5 mg twice daily, then 1 mg twice daily from day eight, for a 12-week course that may be extended. Tablets are taken after food with a full glass of water, which helps with nausea, the commonest side effect. The dose is cut in severe renal impairment, and patients report mood or behaviour changes. Varenicline is on the WHO Model List of Essential Medicines.

Sourcing notes. Varenicline is prescription-only. In 2021 tablets were recalled in several markets after the nitrosamine impurity N-nitroso-varenicline exceeded its acceptable intake, so ask for a nitrosamine risk assessment and batch results against your regulator's limit. The dossier should be CTD or ACTD, with bioequivalence data on the 1 mg strength and zone IVb stability. Blisters protect against moisture, and titration packs need clear day-by-day printing. Ask for each batch's CoA plus the GMP certificate and CoPP. Specify starter or maintenance packs, pack sizes, label language and shelf life on arrival.

Varenicline — third party manufacturing & bulk supply

Varenicline 0.5 mg, 1 mg 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

Varenicline is supplied as 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 Varenicline 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

Varenicline tartrate is used to help people stop smoking by reducing nicotine cravings and withdrawal symptoms. It works by partially stimulating nicotine receptors in the brain while blocking nicotine from cigarettes, which helps reduce the rewarding effects of smoking and supports long-term smoking cessation when combined with behavioral support.

Varenicline products contain the active pharmaceutical ingredient varenicline tartrate. The formulation also includes standard pharmaceutical excipients such as binders, fillers, and coating agents used in tablet manufacturing.

Common trade names include Chantix and Champix along with various generic varenicline tablet brands available in different countries. Chantix and Champix were originally marketed by Pfizer.

Varenicline products are manufactured by several pharmaceutical companies globally, including Pfizer and multiple approved generic manufacturers in regulated markets.

The generic name is varenicline tartrate.

Examples of brand names include Chantix and Champix along with other country-specific generic brands.

Varenicline tartrate tablets are manufactured in several countries including the United States, Europe, India, and other regulated pharmaceutical manufacturing hubs depending on the marketing authorization holder and manufacturer.