Buprenorphine and Naloxone Sublingual Tablets(12mg+3mg)

Buprenorphine and Naloxone Sublingual Tablets (12mg+3mg) 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 (12mg+3mg)

What the Medicine Is & How It Works

Buprenorphine and Naloxone Sublingual Tablets (12mg+3mg) contain a dual-action combination:

• Buprenorphine (12 mg): A partial opioid agonist that reduces cravings and prevents withdrawal symptoms.

• Naloxone (3 mg): An opioid antagonist that blocks misuse and prevents euphoric effects if injected or abused.

This combination is clinically used to:

• Treat opioid addiction

• Support recovery during withdrawal

• Provide long-term dependence maintenance

• Reduce relapse and illicit opioid use

The formulation is administered sublingually for rapid absorption and effectiveness.

  Rising Global Demand for Buprenorphine and Naloxone Tablets

With increasing opioid dependence cases across USA, Canada, Europe, Africa, CIS countries, and Asia, demand for dependable pharmaceutical partners has surged.

Countries seek:

• WHO-GMP approved manufacturers

• High-quality controlled substance production

• Exporters able to meet regulatory and documentation requirements

Taj Pharma India has emerged as a preferred global supplier thanks to its robust infrastructure, regulatory compliance, and unmatched export capabilities.

  Complete Buyer & Importer Guide: Technical, Regulatory & Export Details

Taj Pharma provides every essential document and export support required by international buyers, ministries of health, tenders, and procurement agencies.

  Regulatory Documentation Provided

For Buprenorphine and Naloxone Sublingual Tablets (12mg+3mg), Taj Pharma supplies:

• WHO-GMP Certificate

• COPP (Certificate of Pharmaceutical Product)

• CTD/eCTD Dossier

• Stability Data (Zone II, IV A/B)

• MSDS

• Free Sale Certificate

• Batch Manufacturing Records

• COA (Certificate of Analysis)

• FSC + Manufacturing License

• Bioequivalence (where applicable)

 Packaging, Labeling & Export Customization

Taj Pharma offers:

• Custom export packaging (blister packs/aluminum foil)

• Outer cartons customized with buyer’s branding

• Language-specific labeling

• Moisture-protective, tamper-proof sealing

• Bulk shipping options

All packaging follows Good Distribution Practices (GDP).

 Shelf-Life, Storage & Dosage Form

• Dosage Form: Sublingual tablet

• Strength: Buprenorphine 12mg + Naloxone 3mg

• Shelf-life: 24–36 months

• Storage: Controlled room temperature, 20–25°C

• Presentation: 10×1, 10×10 blister packs

 Export Certifications & Approvals

Taj Pharma is certified with:

• WHO-GMP

• ISO 9001:2015

• EU-GMP aligned quality systems

• MOH approvals for multiple global markets

• Regulatory-compliant API sourcing

 Target Export Markets

Taj Pharma supplies Buprenorphine + Naloxone tablets to:

• South East Asia (Philippines, Vietnam)

• Africa (Kenya, Uganda, Tanzania, Ghana)

• Latin America (Peru, Brazil, Mexico)

• Middle East (UAE, Iraq, Yemen)

• CIS countries (Ukraine, Kazakhstan, Georgia)

• Europe (tender projects)

• USA & Canada (private label supply)

 Why Taj Pharma Is the Most Trusted Buprenorphine and Naloxone Sublingual Tablets (12mg+3mg) Manufacturer in India

1. State-of-the-Art Manufacturing Facilities

Taj Pharma operates from Vapi, Gujarat, equipped with:

• Fully automated manufacturing lines

• Cleanroom Class 100,000 environments

• International quality systems compliant with WHO-GMP

• Precision-controlled substance handling systems

2. Unmatched Quality & Purity Assurance

Each batch undergoes:

• Impurity profiling

• Dissolution and stability testing

• Microbial limit analysis

• Pharmacopoeial compliance (USP/EP/IP)

Taj Pharma guarantees purity, potency, and therapeutic reliability.

3. Competitive & Affordable Pricing

As a high-volume manufacturer, Taj Pharma offers:

• Lowest cost per unit

• Tender-friendly pricing

• Special distributor rates

• PAN India & international supply chain support

4. Global Presence: 

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

Technical Product Specification Table

 Call to Action  

Taj Pharma welcomes global buyers, government procurement agencies, tender suppliers, NGOs, and distributors to collaborate for long-term supply.

To place orders or request quotations:

📩 Email:  info@tajpharma.com
🌐 Website: www.tajpharma.com
📞 Contact:  +91 84484 44095 (Gen. Enq. 01)

Secure WHO-GMP certified, high-quality Buprenorphine and Naloxone Sublingual Tablets (12mg+3mg) at the best price directly from India’s leading manufacturer — Taj Pharma.

  Top 20 FAQs 

1. What is Buprenorphine and Naloxone (12mg+3mg) used for?

Used for opioid dependence treatment and withdrawal management.

2. How do these tablets work?

Buprenorphine reduces cravings; Naloxone prevents misuse.

3. Are these tablets safe?

Yes, when used under medical supervision.

4. Who manufactures the best Buprenorphine Naloxone tablets in India?

Taj Pharma India is the leading manufacturer and exporter.

5. What certifications does Taj Pharma hold?

WHO-GMP, ISO, COPP, CTD dossiers.

6. Is the medicine suitable for long-term maintenance therapy?

Yes, globally used for long-term opioid recovery.

7. What are common side effects?

Headache, sweating, nausea, vomiting, dizziness, constipation.

8. What is the shelf-life?

24–36 months.

9. Can Taj Pharma provide private-label branding?

Yes, full OEM/contract manufacturing support is available.

10. Does Taj Pharma export globally?

Yes, to 40+ countries worldwide.

11. Is this product MOH-registration friendly?

Yes, complete regulatory dossiers are supplied.

12. How are the tablets packaged?

Blister strips with export-grade cartons.

13. Is bulk supply available?

Yes, bulk and retail packaging both available.

14. Can NGOs or tender agencies source from Taj Pharma?

Absolutely, Taj Pharma is a preferred tender manufacturer.

15. What is the recommended dosage?

As prescribed by a certified addiction specialist.

16. Does Taj Pharma offer PCD Pharma Franchise?

Yes, across PAN India.

17. How quickly can export orders be shipped?

Usually within 2–3 weeks.

18. What is Taj Pharma’s quality guarantee?

100% compliance with international pharmacopoeias.

19. Can buyers request samples?

Yes, samples are provided upon regulatory approval.

20. Why choose Taj Pharma?

Quality, affordability, global presence, and top-tier compliance