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Buprenorphine + Naloxone Injection bulk supplier for pharma manufacturers

Buprenorphine + Naloxone Injection Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 0.3 mg/mL, 0.6 mg/mL, 1 mg/mL

Reference Brands: Buprenex(US)

Category: Addiction Medicine / Substance Use

Buprenorphine + Naloxone injection activates mu-opioid receptors, relieving severe pain, while Naloxone blocks opioid effects if injected illicitly, reducing misuse potential. Benefits include rapid, effective pain relief, opioid dependency management, and decreased overdose risk when used responsibly. Suitable for hospital or clinical pain management.

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📘 Sourcing Guide

Product Description:

Buprenorphine + Naloxone injection is approved in the US and EU for opioid dependence treatment, primarily used in clinical settings. In the US, brands like Sublocade are regulated by the FDA, supported by comprehensive dossiers demonstrating safety, efficacy, and manufacturing quality. In the EU, approval by EMA involves extensive dossiers, clinical data, and pharmacovigilance commitments. Due to high abuse potential, strict prescribing regulations and monitoring are enforced in both regions. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access for buprenorphine + naloxone injection, ensuring adherence to European and US standards for safe, effective opioid dependency treatment.

Buprenorphine + Naloxone Injection — third party manufacturing & bulk supply

Buprenorphine + Naloxone Injection 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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Buprenorphine + Naloxone Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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