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

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

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Buprenorphine and Naloxone Sublingual Tablets USP 0.4mg+0.1mg
2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Buprenorphine and Naloxone Sublingual Tablets USP 0.4mg+0.1mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………0.4mg
Naloxone Hydrochloride IP
Eq. to anhydrous Naloxone…….0.1mg
Excipients…………………………q.s.

2. Buprenorphine and Naloxone Sublingual Tablets USP 2mg+0.5mg
Each un-coated sublingual tablet contains:
Buprenorphine Hydrochloride IP
Eq. to Buprenorphine ……………2mg
Naloxone Hydrochloride IP
Eq. to anhydrous Naloxone…….0.5mg
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 & SCHEDULE:

CAUTION: Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
DO NOT BREAK OR CRUSH TABLET.
Driving of vehicle and machine should be avoided after taking the medication.

SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a “Registered Medical Practitioner”.

STORAGE & DOSAGE:

STORAGE: Protect from Light & moisture at temperature not exceeding 30°C. Keep in cool & Dry place.
Keep medicine out of reach of children.
Read enclosed leaflet before use.

Dosage: AS DIRECTED BY THE PHYSICIAN.

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

Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) are a clinically approved combination used in the treatment of opioid dependence. The formulation combines Buprenorphine, a partial opioid agonist, with Naloxone, an opioid antagonist, providing effective maintenance therapy while reducing misuse potential. The 2mg+0.5mg strength is particularly effective for controlled induction and maintenance treatment phases.

Globally, the demand for Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) has surged as healthcare systems and addiction recovery programs adopt evidence-based pharmacotherapy for opioid use disorder (OUD). The U.S., U.K., Canada, Africa, and Asia-Pacific markets have recorded increasing demand due to the growing recognition of medication-assisted treatment (MAT) programs.

Taj Pharma, a well-known Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) manufacturer in India, stands as a pioneer in providing high-quality, affordable, and WHO-GMP-certified formulations trusted by global importers, hospitals, and government tenders.

About Buprenorphine + Naloxone Combination

Buprenorphine + Naloxone is a combination of two medicines used in opioid addiction therapy:

• Buprenorphine acts as a partial opioid agonist, reducing cravings and withdrawal symptoms.

• Naloxone acts as an opioid antagonist, preventing misuse by blocking opioid receptors.

This balanced formulation helps patients maintain long-term recovery without euphoria or dependence—making it an essential product in modern de-addiction therapy programs.

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

• Treatment of opioid dependence and addiction

• Reduces withdrawal symptoms

• Prevents misuse of opioids

• Improves patient compliance and recovery outcomes

• Used in induction and maintenance phases of opioid therapy

Common Side Effects:
Headache, nausea, vomiting, constipation, numbness in mouth, sleepiness, dizziness, and sweating. Taj Pharma ensures pharmaceutical-grade purity and bioavailability to minimize side effects and maximize patient safety.

Leading Manufacturer, Exporter, and Supplier of Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg)

Taj Pharma Ltd, headquartered in Vapi, Gujarat (India), is a WHO-GMP, ISO 9001:2015, and EU-GMP certified pharmaceutical manufacturer. The company is globally recognized for its innovative drug formulations, advanced manufacturing infrastructure, and export excellence in over 80 countries.

Taj Pharma specializes in Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg), offering end-to-end solutions from manufacturing to regulatory support, making it the preferred supplier for global importers and distributors.

Regulatory Documentation and Export Support for Importers/Buyers

Taj Pharma ensures complete regulatory compliance and documentation for smooth import registration.

Documentation Provided:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• CTD/eCTD Dossier

• Product Specification Sheet

• COA (Certificate of Analysis)

• Stability Data & Validation Reports

• Free Sale Certificate

Custom Packaging and Labeling:

• Export-oriented secondary packaging

• Multilingual labeling (English/French/Arabic/Spanish)

• Tamper-proof blister packs

• Custom branding support for distributors

Shelf Life: 24 to 36 months
Storage: Store below 25°C in a dry place, protected from light.
Dosage Form: Sublingual Tablets
Strength Available: 2mg + 0.5mg

Taj Pharma’s logistics and quality team ensures each shipment meets pharmacopoeial standards (IP/BP/USP) and complies with international shipping regulations.

Certifications and Quality Standards

Taj Pharma adheres to the highest pharmaceutical standards, maintaining full compliance with:

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

• EU-GMP

• ISO 9001:2015

• MHRA, FDA, and TGA export requirements

• PIC/S guidelines

Every batch undergoes rigorous in-process quality control, stability testing, and final release verification before export. Taj Pharma’s laboratories are equipped with HPLC, GC, and dissolution testing systems ensuring batch-to-batch consistency.

Why is the Most Trusted Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) Manufacturer in India

1. State-of-the-Art Manufacturing Facilities

Located in Vapi, Gujarat, Taj Pharma’s WHO-GMP-approved facility employs automated, aseptic production with advanced HVAC, cleanroom, and containment systems ensuring contamination-free production.

2. Affordable Pricing with Global Quality

Taj Pharma’s efficient cost structures allow competitive pricing for global importers without compromising quality. The company delivers cost-effective formulations that meet all international pharmacopoeial standards.

3. Global Presence and Distribution

Taj Pharma exports to more than 80 countries, including:

• Top 20 Export Destinations:
  USA, UK, Kenya, Nigeria, South Africa, UAE, Sri Lanka, Philippines, Myanmar, Cambodia, Vietnam, Yemen, Afghanistan, Iraq, Nepal, Bangladesh, Ghana, Peru, Colombia, and Sudan.

4. Strong Regulatory and Technical Support

Taj Pharma provides CTD dossiers, bioequivalence studies, and market authorization assistance to partners, simplifying the product registration process in multiple markets.

5. Proven Track Record of Trust

With over two decades of pharmaceutical expertise, Taj Pharma is recognized among the Top 10 Pharmaceutical Exporters from India, known for timely delivery, product reliability, and consistent quality.

Technical Product Specification

Global Export Markets

Taj Pharma has a robust presence in Asia, Africa, the Middle East, Latin America, and CIS regions. The company maintains strategic export partnerships with importers, NGOs, and government health programs worldwide.

Key Export Markets:

• Africa: Nigeria, Ghana, Kenya, Ethiopia

• Asia: Bangladesh, Nepal, Sri Lanka, Vietnam, Philippines

• Middle East: Yemen, Iraq, UAE

• Latin America: Peru, Colombia, Bolivia

PCD Pharma Franchise and Contract Manufacturing

Taj Pharma also offers PCD Pharma Franchise opportunities for Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) across India. With marketing support, promotional materials, and exclusive territorial rights, partners can build strong regional brands backed by Taj Pharma’s manufacturing expertise.

Contract Manufacturing Services Include:

• Private labeling

• Third-party manufacturing

• Regulatory dossier support

• Packaging customization

• End-to-end logistics management

For importers, distributors, hospitals, and procurement agencies, Taj Pharma offers unmatched reliability, regulatory compliance, and product quality.

Contact Taj Pharma today for the best pricing, regulatory documentation, and supply terms for Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg).

📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📍 Manufacturing Unit: Vapi, Gujarat, India

Top 20 FAQs 

1. What are Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg)?
A combination medicine used for the treatment of opioid dependence.

2. Who manufactures these tablets in India?
Taj Pharma is the leading WHO-GMP-certified manufacturer in India.

3. What is the use of Buprenorphine and Naloxone tablets?
They are used to treat opioid (narcotic) dependence or addiction.

4. What certifications does Taj Pharma have?
WHO-GMP, ISO 9001:2015, EU-GMP, and COPP.

5. Can importers get a full regulatory dossier?
Yes, Taj Pharma provides complete CTD/eCTD dossiers for registration.

6. What is the shelf life?
Typically 24 to 36 months under recommended storage.

7. What is the dosage form?
Sublingual tablets designed for absorption under the tongue.

8. Is the product export-ready?
Yes, fully compliant with international standards.

9. Does Taj Pharma offer private labeling?
Yes, with multilingual packaging and branding support.

10. Are there side effects?
Mild symptoms such as nausea, headache, or dizziness may occur.

11. Can it be used for induction therapy?
Yes, for both induction and maintenance of opioid therapy.

12. What is the packaging format?
Blister packs of 10 tablets, export cartons available.

13. What are the active ingredients?
Buprenorphine HCl 2mg and Naloxone HCl 0.5mg.

14. How should it be stored?
Store below 25°C, away from moisture and light.

15. What is the global demand?
High, especially in Europe, Africa, and South Asia.

16. Is Taj Pharma’s product WHO prequalified?
Manufactured under WHO-GMP standards and COPP certified.

17. Can buyers request custom branding?
Yes, for export and franchise partnerships.

18. What is the minimum order quantity (MOQ)?
Flexible MOQ depending on destination and regulatory needs.

19. How long does export documentation take?
Usually within 15–20 working days post-order confirmation.

20. Why choose Taj Pharma?
For consistent quality, regulatory compliance, and global export expertise.

Taj Pharma stands as the 1 Buprenorphine and Naloxone Sublingual Tablets (2mg+0.5mg) manufacturer and exporter in India, backed by WHO-GMP certification, advanced manufacturing, and global export capability. With a commitment to innovation, affordability, and patient well-being, Taj Pharma continues to lead the world in opioid dependence treatments and pharmaceutical exports.