Buprenorphine + Naloxone Sublingual Tablets bulk supplier for pharma manufacturers

Buprenorphine + Naloxone Sublingual Tablets 2 mg/0.5 mg, 8 mg/2 mg Suppliers & Bulk Manufacturers

Available Forms: Sublingual tablets

Available Strengths: 2 mg/0.5 mg, 8 mg/2 mg

Reference Brands: -

Category: Addiction Medicine / Substance Use

Buprenorphine and naloxone sublingual tablets, 2 mg/0.5 mg and 8 mg/2 mg, for opioid dependence treatment programmes, hospitals and licensed importers holding the permits that controlled medicines require.

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Product Description:

These sublingual tablets combine buprenorphine, a partial opioid agonist, with naloxone, an opioid antagonist, at 2 mg/0.5 mg and 8 mg/2 mg. Buprenorphine binds tightly to mu-opioid receptors but activates them only partly, easing withdrawal and craving. Naloxone is poorly absorbed under the tongue, but if the tablet is crushed and injected it becomes active and can bring on withdrawal, which discourages injection. The sublingual route matters because swallowed buprenorphine is largely broken down by the liver.

It is used as opioid agonist treatment for opioid dependence in adults and adolescents, within medical, social and psychological support. The first dose is given once clear withdrawal signs appear, because dosing too early can precipitate withdrawal. The tablet dissolves under the tongue without chewing or swallowing. The main danger is breathing depression with benzodiazepines, alcohol or other sedatives. Liver function is monitored. Use in pregnancy can cause neonatal withdrawal, and regulators have warned about dental problems with medicines dissolved in the mouth.

Sourcing notes. Buprenorphine is a controlled medicine in many countries, and this combination is controlled with it. Supply moves only when the importer holds the required import permit and the exporter the matching export authorisation for every consignment. A CTD or ACTD dossier with bioequivalence data is the norm. Tablets usually come in moisture-protective, often child-resistant blisters, kept at room temperature in locked storage with full records; zone IVb stability data matters in hot, humid markets. Ask for a CoA per batch plus GMP and CoPP. Specify strength, pack count and permit numbers.

Buprenorphine + Naloxone Sublingual Tablets — third party manufacturing & bulk supply

Buprenorphine + Naloxone Sublingual Tablets 2 mg/0.5 mg, 8 mg/2 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

Buprenorphine + Naloxone Sublingual Tablets is supplied as Sublingual 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 Buprenorphine + Naloxone Sublingual Tablets 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

Buprenorphine + Naloxone is used for the treatment of opioid dependence. It helps reduce withdrawal symptoms and cravings while lowering the risk of misuse because naloxone blocks opioid effects if the medicine is taken improperly.

It is made from two active ingredients: buprenorphine hydrochloride, a partial opioid agonist, and naloxone hydrochloride, an opioid antagonist that prevents abuse.

The most common trade name is Buprenex, Suboxone.

Suboxone was originally developed and marketed by Indivior. Many other pharmaceutical companies manufacture generic versions worldwide.

The generic name is buprenorphine hydrochloride and naloxone hydrochloride.

The well-known brand name is Buprenex, Suboxone.

It is manufactured in several countries, including India, the USA, and multiple EU regions, by different branded and generic pharmaceutical manufacturers.