Buprenorphine Sublingual Tablets 8mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Buprenorphine Sublingual Tablets 0.2mg
2. Buprenorphine Sublingual Tablets 0.4mg
3. Buprenorphine Sublingual Tablets 2mg
4. Buprenorphine Sublingual Tablets 8mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Buprenorphine Sublingual Tablets 0.2mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride USP
Equivalent to
Buprenorphine Base ………………….0.2mg
Excipients……………………………………q.s
Colour: Tartrazine

2. Buprenorphine Sublingual Tablets 0.4mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride USP
Equivalent to
Buprenorphine Base ………………….0.4mg
Excipients……………………………………q.s
Colour: Riboflavin

3. Buprenorphine Sublingual Tablets 2mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride USP 2.16mg
Equivalent to  Buprenorphine Base ………………….2mg
Excipients……………………………………q.s
Colour: Sunset yellow lake

4. Buprenorphine Sublingual Tablets 8mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride USP 8.64
Equivalent to
Buprenorphine Base……………………8mg
Excipients……………………………………q.s
Colour: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Buprenorphine is FDA-approved for acute pain, chronic pain, and opioid dependence. It is an agent used in agonist substitution treatment, which is a process for treating addiction by using a substance (such as buprenorphine or methadone) to substitute for a stronger full agonist opioid (such as heroin).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in tight container with child resistant closure.

WARNING: PRESCRIPTION DRUG CAUTION- IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH THE MEDICAL ADVICE.

NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

1. Introduction to Buprenorphine Sublingual Tablets 8mg

What Are Buprenorphine Sublingual Tablets 8mg?

Buprenorphine Sublingual Tablets 8mg is a partial opioid agonist widely used for:

• Treatment of opioid use disorder (OUD)

• Detoxification and maintenance therapy

• Management of severe chronic pain

• Preventing withdrawal symptoms in opioid-dependent patients

The tablet is placed under the tongue (sublingual route), ensuring fast absorption and effective therapeutic action.

Why Is It in Global Demand?

The global opioid crisis has led to an exponential rise in the demand for Buprenorphine Sublingual Tablets 8mg across the USA, EU, Africa, Southeast Asia, and LATAM. Ministries of Health, NGOs, rehabilitation centers, and importers rely heavily on certified manufacturers.

Why Taj Pharma?

Taj Pharma is a WHO-GMP, FDA-compliant pharmaceutical manufacturer known for its high-quality formulations, stringent quality processes, reliable exports, and competitive pricing.

Being a trusted Buprenorphine Sublingual Tablets 8mg supplier in India, Taj Pharma ensures:

• Accurate dosage

• Compliance with international pharmacopeias

• Batch-to-batch consistency

• Superior packaging and long shelf-life

2. In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided by Taj Pharma

Taj Pharma provides a complete export-friendly regulatory dossier, including:

• WHO-GMP Certificate

• COA (Certificate of Analysis)

• COPP (Certificate of Pharmaceutical Product)

• CTD/ACTD Dossier (Modules 1–5)

• MOH Registration Support

• Free Sale Certificate

• Stability Data (Zone II & IVB)

• GMP Site Master File

• FDA Compliance Documents

• BMR/BPR, Batch Validation, and QA Documentation

This makes Taj Pharma one of the most preferred exporters of Buprenorphine Sublingual Tablets 8mg from India.

Custom Packaging & Private Labeling

Importers can choose:

• Blister packs / Alu-Alu / PVC-PVDC packaging

• HDPE bottles

• Customized carton design

• Multilingual labels (French, Arabic, Spanish, Russian)

• Buyer-specific branding (OEM/White Label Manufacturing)

Shelf-Life, Storage & Dosage Form

• Dosage Form: Sublingual tablet

• Strength: Buprenorphine 8mg

• Shelf Life: 24–36 months

• Storage: Store below 30°C, protect from light & moisture

Export Certifications Held by Taj Pharma

Taj Pharma holds multiple national and international certifications:

• WHO-GMP

• EU-GMP-equivalent standards

• ISO 9001:2015

• ISO 14001

• COPP from various authorities

• GLP certification

• MOH approvals across multiple countries

This makes Taj Pharma one of the most compliant Buprenorphine Sublingual Tablets 8mg manufacturers in India.

Target Countries & Export Markets

Taj Pharma exports Buprenorphine to:
USA, UK, South Africa, Kenya, Nigeria, Ghana, UAE, Oman, Qatar, Vietnam, Philippines, Myanmar, Sri Lanka, Afghanistan, Iraq, Peru, Chile, Colombia, Dominican Republic, Haiti, Yemen, Tanzania, Uganda, Zambia, Nepal, Bangladesh, and many others.

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

State-of-the-Art Manufacturing Facility

Taj Pharma’s Vapi facility includes:

• WHO-GMP compliant production lines

• Automated tablet compression units

• Temperature & humidity-controlled clean rooms

• High-end blister packing lines

• Microbiology & analytical testing labs

Affordable Pricing with Assured Quality

Taj Pharma delivers the best cost advantage due to:

• In-house API sourcing

• High-production capacity

• Economies of scale

• Low wastage & lean manufacturing

This allows competitive prices for international tenders and bulk orders.

Global Supply Chain Strength

Taj Pharma ensures:

• Door-to-port and door-to-door shipping

• Cold-chain logistics where required

• Export documentation support

• 24/7 order tracking

Top 20 Countries Taj Pharma Exports To

India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile

4. Technical Product Specification Table

5. Call to Action for Buyers, Importers & Distributors

Looking for a reliable WHO-GMP-certified Buprenorphine Sublingual Tablets 8mg Manufacturer in India?
Want competitive pricing, top-quality products, and fast export support?

➡ Contact Taj Pharma Today

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

 6. Top 20 FAQs  

1. What is Buprenorphine Sublingual Tablet 8mg used for?

It is used for treating opioid use disorder and severe pain management.

2. Is Taj Pharma a WHO-GMP certified manufacturer?

Yes, Taj Pharma is WHO-GMP, ISO-certified, and globally trusted.

3. Does Taj Pharma provide regulatory dossiers?

Yes, full CTD/ACTD dossiers and COPP can be provided.

4. Can I order custom packaging?

Yes, multilingual and private-label packaging is available.

5. What is the shelf life?

24–36 months depending on buyer requirements.

6. Does Taj Pharma export worldwide?

Yes, Taj Pharma exports to more than 40+ countries.

7. Is Buprenorphine 8mg a controlled drug?

Yes. Export requires compliance with narcotic regulations.

8. How is it administered?

Placed under the tongue for quick absorption.

9. Is Taj Pharma’s price competitive?

Yes, pricing is highly competitive due to in-house manufacturing.

10. Can small distributors place orders?

Yes, MOQ can be customized.

11. Do you offer samples for registration?

Yes, sample supply is available.

12. What pharmacopeia standard is used?

USP / EP depending on buyer request.

13. Do you assist with MOH product registration?

Yes, full technical support is provided.

14. Can you export to Africa and the Middle East?

Yes, Taj Pharma is established in these markets.

15. Are stability studies available?

Yes, real-time & accelerated data.

16. Can orders be shipped urgently?

Express dispatch is available depending on stock.

17. Do you provide third-party manufacturing?

Yes, OEM and private label services are offered.

18. Does Buprenorphine 8mg cause side effects?

Common effects include dizziness, nausea, drowsiness, and constipation.

19. What documentation is required for import?

Import permit, narcotics license, and MOH approval.

20. Why is Taj Pharma the best exporter?

Quality, compliance, competitive pricing, global trust, and end-to-end export support.