Buprenorphine + Naloxone Sublingual Films/Tablets Suppliers & Bulk Manufacturers
Available Forms: Sublingual Films/Tablets
Available Strengths: 2 mg buprenorphine / 0.5 mg naloxone, 8 mg / 2 mg
Reference Brands: Suboxone(US)
Category: Analgesic
Buprenorphine + Naloxone sublingual films/tablets activate mu-opioid receptors, relieving pain and preventing withdrawal. Naloxone blocks opioid effects if injected, reducing misuse. Benefits include effective pain relief, lower overdose risk when used properly, and convenience of sublingual administration, promoting adherence and safety in opioid dependence and pain management. Buprenorphine + Naloxone Sublingual Films/Tablets is available in Sublingual Films/Tablets and strengths such as 2 mg buprenorphine / 0.5 mg naloxone, 8 mg / 2 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Buprenorphine + Naloxone Sublingual Films/Tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Buprenorphine + Naloxone Sublingual Films/Tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
Product Description:
Buprenorphine + Naloxone sublingual films and tablets are approved in the EU and US primarily for opioid dependence treatment, with some off-label use for pain. In the US, brands like Suboxone are regulated by the FDA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the EU, approval by EMA involves comprehensive dossiers, clinical data, and pharmacovigilance plans. Due to abuse potential, strict prescribing controls and monitoring are enforced. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support efficient market access for buprenorphine + naloxone formulations, ensuring adherence to European and US standards for safe, effective opioid dependence management and pain therapy.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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 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 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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