Buprenorphine 8 mg /Naloxone 2 mg Tablets | Generic MAT Treatment
CAS: 53152-21-9 (Buprenorphine) / 465-65-6 (Naloxone)
Vonage Pharma is a leading GMP-certified manufacturer of high-quality generic Buprenorphine and Naloxone Sublingual Tablets (8 mg / 2 mg). This critical Medication-Assisted Treatment (MAT) product is engineered to meet rigorous pharmacopeial standards (USP/EP), providing a reliable, effective, and affordable solution for managing opioid use disorder (OUD). We support global healthcare providers and distributors with a secure API and finished dosage supply chain.
Key Benefits of Our Buprenorphine Naloxone 8mg/2mg Tablets
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Proven Bioequivalence: Ensures consistent therapeutic performance and patient outcomes.
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High-Bar Quality Control: Manufactured under strict GMP guidelines with 99.5%+ HPLC purity and comprehensive impurity profiling (ICH Q3D).
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Secure Supply Chain: Mitigate shortage risks with our vertically integrated API-to-tablet production and bulk order capacity.
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Global Regulatory Compliance: Full documentation support, including DMF, CEP, and GMP, for seamless entry in emerging markets.
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Patient-Focused Formulation: Optimized sublingual bioavailability and palatability to support treatment adherence.
Technical Specifications
Parameter | Specification |
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Dosage Form | Sublingual Tablet |
Strength | Buprenorphine HCl, 8 mg / Naloxone HCl Dihydrate, 2 mg |
Appearance | White to off-white hexagonal tablet |
Purity (HPLC) | ≥ 99.5% |
Pharmacopeia | Complies with USP/EP/BP Monographs |
Shelf Life | 24 months |
Packaging | 30-count blister packs; custom bulk packaging available |
Mechanism of Action: Effective Opioid Dependence Therapy
This combination product is a cornerstone of modern opioid addiction treatment:
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Buprenorphine: A partial opioid agonist that reduces cravings and withdrawal symptoms by binding to brain receptors without producing a full euphoric high.
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Naloxone: An opioid antagonist that blocks the effects of opioids and deters misuse. When taken sublingually as directed, the naloxone has minimal effect; if injected, it precipitates withdrawal.
Applications and Indications
This product is indicated for the maintenance treatment of opioid dependence and must be part of a comprehensive treatment plan that includes counseling and psychosocial support.
Why Source from Vonage Pharma?
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Vertical Integration: We control the entire process from Buprenorphine API synthesis to finished tablet production, ensuring quality at every step.
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Unmatched Reliability: Our scalable manufacturing capabilities guarantee a consistent supply for large-scale government tenders and institutional programs.
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Expert Regulatory Support: Our team provides extensive documentation (CofA, GMP Certs, DMFs) to accelerate your approval process with agencies like the FDA and EMA.
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Competitive Bulk Pricing: We offer cost-effective solutions for public health initiatives and large distributors without compromising on quality.
Ordering and Contact Information
Vonage Pharma supplies Buprenorphine Naloxone 8mg/2mg tablets in commercial bulk quantities to qualified distributors, government bodies, and healthcare institutions. Contact our sales team today to request a quote, a product sample, or a comprehensive product dossier.
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