Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg)

Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg) 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: Understanding Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg)

Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg) are a globally essential combination medicine used for the treatment of opioid (narcotic) dependence or addiction. The formulation combines:

• Buprenorphine (8 mg) – a partial opioid agonist that helps suppress withdrawal symptoms by mimicking mild opioid effects.

• Naloxone (2 mg) – an opioid antagonist that blocks euphoric effects and prevents misuse.

This combination is widely recommended in induction and maintenance therapy for patients undergoing recovery from opioid dependence. It is administered sublingually (under the tongue) for quick absorption and optimum therapeutic action.

The worldwide demand for Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg) continues to rise as more nations adopt modern de-addiction therapies. Global health systems, rehabilitation centers, NGOs, and government programs rely on high-purity, WHO-GMP-compliant manufacturers from India.

Why India? Why Taj Pharma?

India is a trusted destination for high-quality, affordable psychiatric and addiction-management medicines. Taj Pharma, headquartered in Vapi, Gujarat, is among the most reputed manufacturers, suppliers, and exporters of Buprenorphine + Naloxone tablets globally.

2. Complete Guide for Importers, Distributors & Overseas Pharma Buyers

Global buyers require a dependable manufacturer who can supply regulatory-compliant, certified, stable, and export-ready medication formulations. Taj Pharma fulfills all critical requirements.

Regulatory Documentation Provided by Taj Pharma

Taj Pharma supplies a full regulatory package, including:

• WHO-GMP Certificate

• COAs (Certificate of Analysis)

• CTD Dossier (Modules 1–5)

• Free Sale Certificate (FSC)

• Certificate of Pharmaceutical Product (COPP)

• DMF (where applicable)

• Stability Data (Real-time & Accelerated)

• Batch Manufacturing Records (BMR)

• COO (Certificate of Origin)

These documents ensure seamless approvals for tenders, import licensing, and drug registration across Africa, Asia, Europe, Middle East, and Latin America.

Custom Packaging & Labeling Options

Taj Pharma offers tailor-made export packaging, including:

• Blister / Alu-Alu / Alu-PVC packing

• HDPE bottles

• Custom multilingual labeling

• Buyer-brand or neutral branding

• Anti-counterfeit measures (QR codes, holograms, barcodes)

This flexibility allows importers to meet country-specific branding guidelines and commercial preferences.

Shelf Life, Storage & Dosage Form

Export Certifications Ensuring Global Acceptance

Taj Pharma holds some of the most respected international certifications:

• WHO-GMP (World Health Organization Good Manufacturing Practices)

• ISO 9001:2015 Quality Management

• GLP-Compliant Labs

• EU-GMP aligned processes

• Regulatory Dossiers in CTD Format

• COPP for major markets

These certifications make Taj Pharma a preferred manufacturer for:

• Government tenders

• International NGOs

• Global hospitals

• Distributors & importers

• PCD franchise holders

Target Countries & Global Export Markets

Taj Pharma exports Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg) to 45+ countries, especially:

• UK, Germany, Romania, Poland

• South Africa, Kenya, Uganda, Ethiopia

• UAE, Saudi Arabia, Oman, Qatar

• Myanmar, Philippines, Thailand

• Chile, Peru, Bolivia, Mexico

• Afghanistan, Bangladesh, Nepal, Sri Lanka

The company maintains a robust supply chain ensuring timely delivery for bulk orders.

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

Taj Pharma stands out among Indian pharmaceutical manufacturers due to its commitment to quality, compliance, affordability, and global reach.

State-of-the-Art Manufacturing Facilities

• WHO-GMP, ISO-certified production units

• Clean-room manufacturing environments

• Fully automated lines & controlled manufacturing

• In-house microbiology & QC/QA departments

• Zero cross-contamination facility

Affordability Without Compromising Quality

Taj Pharma aims to deliver high-quality medicines at competitive export pricing. This is crucial for markets where affordability determines patient compliance.

Global Presence & Strong Supply Chain Support

• Multi-country product registrations

• Strong export logistics team

• Support for tenders, registrations, and supply programs

• Ability to supply small, medium, and large consignments

Top 20 Countries 

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

4. Technical Product Specification Table

5. Call to Action  

If you are a global importer, distributor, tender participant, or PCD franchise seeker, Taj Pharma is your most reliable partner for Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg).

📩 Contact for Business Enquiries:

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

6. Top 20 FAQs

1. What are Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg)?
A combination medicine for opioid dependence used under medical supervision.

2. Who manufactures the best Buprenorphine + Naloxone tablets in India?
Taj Pharma is among the top WHO-GMP certified manufacturers.

3. What is Buprenorphine’s role?
It reduces withdrawal symptoms and cravings.

4. What is Naloxone’s role?
It prevents misuse and blocks euphoric effects.

5. Are Taj Pharma’s products export compliant?
Yes—WHO-GMP, CTD dossiers, COPP provided.

6. Can international buyers request custom packaging?
Yes, including private labeling.

7. What is the shelf life?
24–36 months.

8. What certifications does Taj Pharma have?
WHO-GMP, ISO, GLP-compliance.

9. Do these tablets require cold storage?
No, store below 25°C.

10. Are they suitable for government tenders?
Yes, compliant with global regulatory standards.

11. Can Taj Pharma support product registration in other countries?
Yes—full regulatory support is provided.

12. What are common side effects?
Headache, sweating, nausea, dizziness, constipation, back pain, sleepiness.

13. Are bulk orders accepted?
Yes, Taj Pharma handles all order sizes.

14. Does Taj Pharma offer PCD Pharma Franchise?
Yes, PAN-India PCD franchise available.

15. Which countries does Taj Pharma export to?
Africa, Asia, Europe, Middle East, Latin America.

16. Is the product safe?
Yes, manufactured under strict WHO-GMP standards.

17. What is the mode of administration?
Sublingual (under the tongue).

18. Is naloxone necessary in the formulation?
Yes, to prevent misuse or overdose.

19. Can the tablets cause addiction?
No—when used as prescribed, they help treat addiction.

20. Why choose Taj Pharma as a supplier?
Quality, affordability, reliability, certifications, and global experience.

Taj Pharma stands as a leading Buprenorphine and Naloxone Sublingual Tablets (8mg+2mg) Manufacturer, Supplier & Exporter in India, trusted by hospitals, importers, and governments across the world. With top-quality certifications, robust manufacturing, global logistics, and affordable pricing, Taj Pharma consistently delivers excellence in addiction-treatment pharmaceuticals.

If you aim to source the best quality Buprenorphine + Naloxone tablets at competitive prices, Taj Pharma is your ideal partner.