Neurological & CNS

Buprenorphine + NaloxoneThird Party Manufacturing in India

Looking to get Buprenorphine + Naloxone manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
N/A (Combination)
Drug Class
Partial Mu-Opioid Agonist + Opioid Antagonist
Molecular Formula
N/A (Combination)
Molecular Weight
N/A (Combination)
Grade Standards
IP, USP, BP
Therapeutic Category
Neurological & CNS
MOQ
Contact us for MOQ — varies by strength and dosage form
Dosage Forms
Sublingual Tablet

Mechanism of Action

Buprenorphine + Naloxone works through a dual-mechanism approach designed to treat opioid dependence while minimizing the risk of drug abuse and diversion.

Buprenorphine acts as a partial mu-opioid receptor agonist and a kappa-opioid receptor antagonist. Due to its high binding affinity but low intrinsic activity, it binds strongly to mu-opioid receptors, effectively blocking full opioid agonists from binding. This action suppresses cravings and withdrawal symptoms. Buprenorphine exhibits a pharmacological "ceiling effect," meaning its opioid-like effects plateau at higher doses, which significantly increases safety and reduces the risk of respiratory depression compared to full agonists. Naloxone is a potent mu-opioid receptor antagonist. When the combination is taken sublingually as prescribed, naloxone has negligible oral bioavailability and exerts no clinical effect. However, if the medication is dissolved and injected or snorted, naloxone is rapidly absorbed and immediately displaces buprenorphine and other opioids from the receptors. This precipitates acute withdrawal symptoms in opioid-dependent individuals, acting as a powerful deterrent to misuse.

Unlike methadone therapy, which uses a full agonist, this combination offers a safer outpatient treatment option with reduced abuse potential. It is highly effective for long-term maintenance in patients recovering from opioid use disorder.

Therapeutic Uses & Indications

Therapeutic Uses

Buprenorphine + Naloxone is indicated for the treatment of opioid dependence as part of a comprehensive treatment plan including medical, social, and psychological support. It is prescribed for:

  • Opioid Use Disorder (OUD): Helps patients transition away from dependence on full opioid agonists (e.g., heroin, oxycodone, morphine).
  • Withdrawal Management: Alleviates acute physical symptoms during the initial detox and stabilization phases of recovery.
  • Maintenance Therapy: Suppresses long-term cravings and reduces the risk of relapse during the rehabilitation process.
  • Abuse Deterrence: Prevents illicit intravenous or intranasal misuse due to the presence of naloxone.

Why Manufacturers Choose Buprenorphine + Naloxone

With the global increase in opioid addiction and stricter regulations surrounding narcotic distribution, Buprenorphine + Naloxone has emerged as a gold standard in addiction medicine. Because it can be prescribed for at-home use, it offers a major logistical advantage over methadone, which requires daily clinic visits. Developing stable sublingual tablets that release both ingredients in the exact ratio is a highly specialized process, ensuring high barriers to entry and strong margins for contract manufacturing partners.

This makes Buprenorphine + Naloxone a highly valued product for third party manufacturing in India. The drug's strategic importance in international public health makes it a key target for export-oriented manufacturers supplying government healthcare programs and specialized addiction treatment centers worldwide.

Dosage Forms We Manufacture

Sublingual Tablet
0.4mg + 0.1mg · 2mg + 0.5mg

Frequently Asked Questions

What is the minimum order quantity for Buprenorphine + Naloxone?
Minimum order quantity for Buprenorphine + Naloxone is Contact us for MOQ — varies by strength and dosage form. Please contact us for bulk pricing and custom quantities.
What dosage forms of Buprenorphine + Naloxone can you manufacture?
We manufacture Buprenorphine + Naloxone as: Sublingual Tablet (0.4mg + 0.1mg, 2mg + 0.5mg).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Buprenorphine + Naloxone for export?
Yes. We provide export-ready Buprenorphine + Naloxone formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Buprenorphine + Naloxone?
We manufacture Buprenorphine + Naloxone to IP, USP, BP pharmacopoeial standards.
Third Party Manufacturing

Get Buprenorphine + Naloxone made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
Get a Manufacturing QuoteWhatsApp Us Now

+91 9689237122 · replies within hours

Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Blister pack (Alu-Alu), Strip pack, HDPE bottle. Packaging customized to client brand guidelines.

Start Manufacturing Buprenorphine + Naloxone Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Buprenorphine + Naloxone across all dosage forms. PCD franchise and export orders welcome.

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