Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg)

Buprenorphine and Naloxone Sublingual Tablets  (2mg+0.5mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
2. Buprenorphine and Naloxone Sublingual Tablets USP 8mg+2mg
3. Buprenorphine and Naloxone Sublingual Tablets USP 12mg+3mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride USP
Eq. to Buprenorphine ……………2mg
Naloxone Hydrochloride dihydrate USP
Eq. to anhydrous Naloxone…….0.5mg
Excipients…………………………q.s.

2. Buprenorphine and Naloxone Sublingual Tablets USP 8mg+2mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride USP
Eq. to Buprenorphine ……………8mg
Naloxone Hydrochloride dihydrate USP
Eq. to anhydrous Naloxone…….2mg
Excipients…………………………q.s.

3. Buprenorphine and Naloxone Sublingual Tablets USP 12mg+3mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride USP
Eq. to Buprenorphine ……………12mg
Naloxone Hydrochloride dihydrate USP
Eq. to anhydrous Naloxone…….3mg
Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Buprenorphine and naloxone sublingual tablet are used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet is used for induction and maintenance treatment of opioid (narcotic) dependence.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Driving of vehicle and machine should be avoided after taking the medication.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Store in dry place protected from light and moisture.

DOSAGE: As directed by the Physician.

Attach dispensing label as per end country.

Introduction to Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg)

Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) are widely prescribed globally for the treatment of opioid dependence. This life-saving formulation is recommended for both induction and maintenance therapy in patients undergoing withdrawal from narcotic drugs.

The combination contains:

• Buprenorphine 2mg – a partial opioid agonist that helps reduce cravings and withdrawal symptoms.

• Naloxone 0.5mg – an opioid antagonist that prevents misuse by blocking opioid receptors.

This strength is ideal for dose tapering, maintenance therapy, and controlled treatment programs.

With rising opioid dependence worldwide, there is significant global demand for high-quality, regulatory-compliant manufacturers—especially from India. Among them, Taj Pharma stands out as a trusted name.

India’s Leading Manufacturer of Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg)

Taj Pharma is a well-known Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) manufacturer in India, offering unmatched consistency, purity, and regulatory standards. Manufactured in WHO-GMP certified facilities in Vapi, Gujarat, these tablets meet stringent global quality benchmarks.

Taj Pharma’s formulation is widely used in:

• De-addiction centers

• Government opioid treatment programs

• Rehabilitation hospitals

• Global NGO supply chains

• International tenders

The company ensures every batch adheres to pharmacopoeial standards, making it a preferred choice for importers, distributors, and treatment centers worldwide.

2. Complete Guide for Importers / Exporters / Global Buyers

If you’re sourcing Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg), Taj Pharma provides comprehensive support that simplifies registration, import approval, and large-scale procurement.

Regulatory Documentation Provided by Taj Pharma

Taj Pharma provides a complete regulatory dossier for smooth international registration:

• WHO-GMP Certificate

• COPP (Certificate of Pharmaceutical Product)

• CTD/ACTD Dossier – Module 1–5

• Stability Studies (Accelerated & Real-Time)

• COA – Certificate of Analysis

• Free Sale Certificate (FSC)

• Certificate of Origin

• BMR/BPR

• MSDS

This helps importers receive swift clearance from their national regulatory authorities, making Taj Pharma ideal for tender submissions.

Custom Packaging & Labeling Options for Exporters

Taj Pharma offers fully customizable packaging:

• Alu-Alu / Alu-PVC blister packs

• HDPE bottles or bulk packs

• Custom branding with buyer’s label

• Multilingual packs (Arabic, French, Spanish, Russian, etc.)

• Tamper-proof & anti-counterfeit layers

• Export-strength cartons

This ensures compliance with individual country requirements.

Shelf-Life, Storage & Dosage Form Details

Export Certifications Available

Taj Pharma is fully certified to manufacture and export regulated medication globally:

• WHO-GMP Certified

• ISO 9001:2015 Quality System

• GLP Certified Laboratory

• EU-GMP compliant production standards

• Regulatory-compliant packaging & testing

This makes Taj Pharma a globally accepted manufacturer for government procurement and private distribution.

Target Countries & Export Markets

Taj Pharma supplies Buprenorphine and Naloxone Tablets to:

• Africa: Nigeria, Kenya, Ethiopia, Uganda, South Africa

• Middle East: UAE, Oman, Kuwait, Qatar, Bahrain, Yemen

• CIS Nations: Kazakhstan, Armenia, Georgia

• South Asia: Nepal, Sri Lanka, Afghanistan, Bangladesh

• Southeast Asia: Myanmar, Cambodia, Philippines

• Latin America: Chile, Peru, Mexico, Bolivia

Export demand for Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) continues to surge due to increasing global opioid rehabilitation needs.

3. Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

State-of-the-Art WHO-GMP Manufacturing Facilities

Taj Pharma’s production facilities are equipped with:

• Controlled contamination-free zones

• Automated production lines

• Modern analytical testing equipment

• High-precision granulation, mixing, and tablet compression systems

• In-house microbiology & stability chambers

This ensures every tablet meets global quality expectations.

Affordable Pricing & Guaranteed Quality

Taj Pharma offers competitive pricing that supports:

✔ Government health tenders
✔ NGO-run programs
✔ Private distributors
✔ Bulk importers

Every batch undergoes physicochemical, microbial, stability, and dissolution testing before release.

Global Presence & Supply Chain Strength

Taj Pharma excels in:

• Fast documentation support

• Efficient export logistics

• Product registration assistance

• Bulk and small-batch supply

• Consistent stock availability

With a strong export network in 40+ countries, Taj Pharma ensures timely delivery and seamless coordination.

Top 20 Countries 

Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia

4. Technical Product Specification Table

5. Call to Action  

If you are seeking a reliable, certified, and globally trusted manufacturer for Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg), Taj Pharma is your ideal partner.

📩 Business Enquiries – Contact Taj Pharma

Taj Pharma India Ltd.
Vapi, Gujarat – India
🌐 Website: www.tajpharma.com
📧 Email:  info@tajpharma.com

6. Top 20 FAQs

1. What are Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg)?

A combination medicine used to treat opioid addiction and withdrawal.

2. Who is the best manufacturer in India?

Taj Pharma is one of the leading WHO-GMP certified manufacturers.

3. How does Buprenorphine work?

It reduces cravings and withdrawal symptoms by acting as a partial opioid agonist.

4. What does Naloxone do?

It blocks opioid effects and prevents misuse.

5. What certifications does Taj Pharma have?

WHO-GMP, ISO 9001:2015, GLP compliance, CTD dossiers.

6. Can Taj Pharma export globally?

Yes, to 40+ countries.

7. Does Taj Pharma provide custom packaging?

Yes—private label and multilingual packs.

8. What is the shelf life?

2–3 years depending on climate zone.

9. Are samples available?

Yes—subject to regulatory permissions.

10. Does Taj Pharma provide PCD Pharma Franchise?

Yes, PAN-India.

11. Is this formulation safe?

Yes, when used under medical supervision.

12. What are the common side effects?

Headache, sweating, nausea, dizziness, constipation, tongue pain.

13. Can it be used for long-term maintenance?

Yes, as recommended by doctors.

14. What packaging options are available?

Blister, Alu-Alu, bulk, and custom labeling.

15. Is Taj Pharma affordable for tenders?

Yes—competitive pricing for tenders and NGOs.

16. Is a CTD dossier available?

Yes, including stability data.

17. Does Taj Pharma supply bulk quantities?

Yes, from 50,000–10 million tablets.

18. Can the product be branded for the distributor?

Yes.

19. What dosage form is available?

Sublingual film-coated tablets.

20. Why choose Taj Pharma?

Quality, certifications, pricing, global presence, and reliability.

Taj Pharma stands as a leading Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) Manufacturer Supplier in India, trusted by governments, hospitals, and distributors worldwide. With advanced WHO-GMP facilities, robust documentation support, and competitive pricing, Taj Pharma is the ideal partner for global buyers seeking reliable opioid-dependence treatment medicines.