Buprenorphine Sublingual Tablets 1mg

Buprenorphine Sublingual Tablets 1mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Buprenorphine Sublingual Tablets IP 0.2mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride IP
Equivalent to
Buprenorphine……………………………0.2mg
Excipients……………………………………q.s
Colour: Titanium Dioxide IP

2. Buprenorphine Sublingual Tablets IP 0.4mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride IP
Equivalent to
Buprenorphine……………………………0.4mg
Excipients……………………………………q.s
Colour: Ponceau 2R

3. Buprenorphine Sublingual Tablets IP 1mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride IP
Equivalent to
Buprenorphine……………………………1mg
Excipients……………………………………q.s
Colour: Ponceau 4R

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

5. Buprenorphine Sublingual Tablets IP 8mg
Each Un-coated Sublingual tablet contains:
Buprenorphine Hydrochloride IP
Equivalent to
Buprenorphine……………………………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 & SCHEDULE:

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

SCHEDULE: SCHEDULE H1: 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 below 30°C.
Protect from Light and moisture.

Dosage: As directed by the Physician.

Introduction to Buprenorphine Sublingual Tablets 1mg

Buprenorphine Sublingual Tablets 1mg are a low-dose opioid partial agonist formulation primarily designed for:

• Moderate to severe pain management, including post-operative and cancer-related pain

• Long-term pain relief when weaker analgesics fail

• Opioid withdrawal management, preventing withdrawal symptoms by mimicking the effects of other opioid drugs

Mechanism of Action:
Buprenorphine acts on specific opioid receptors in the brain and spinal cord, reducing pain perception and easing withdrawal symptoms. Its partial agonist activity makes it safer than full opioid agonists, reducing the risk of abuse and severe respiratory depression.

Global Demand:
With a rising prevalence of chronic pain conditions and opioid dependence worldwide, the demand for high-quality Buprenorphine Sublingual Tablets 1mg is increasing among international buyers, hospitals, and healthcare providers.

Taj Pharma stands out as a reliable Buprenorphine Sublingual Tablets 1mg manufacturer in India, delivering quality products that meet international standards.

Established Manufacturer, Exporter, and Supplier

Based in Vapi, Gujarat, India, Taj Pharma Ltd is a trusted manufacturer, exporter, and supplier of Buprenorphine Sublingual Tablets 1mg.

Key Strengths:

• WHO-GMP and EU-GMP-certified manufacturing facilities

• High-quality tablets with consistent purity and potency

• Strong international logistics network for timely delivery

Advantages for Global Buyers:

• Customizable packaging and labeling for export

• Competitive pricing without compromising quality

• Comprehensive regulatory support for import compliance

Clinical Uses and Administration

Buprenorphine Sublingual Tablets 1mg are widely used for:

• Acute and chronic pain management

• Pain following surgery, injury, or cancer therapy

• Prevention and management of opioid withdrawal symptoms

Dosage and Administration Guidelines:

• Take at the same time every day for consistent drug levels

• Administer sublingually for optimal absorption

• Rise slowly from sitting or lying positions to prevent dizziness

• Adjust dosage under medical supervision

Common Side Effects:

• Withdrawal symptoms, dizziness, and vertigo

• Drowsiness, insomnia, headache, back pain

• Nausea, vomiting, sweating, constipation

• Abdominal pain, weakness, flu-like symptoms

Precautions:

• Avoid alcohol while taking the medication

• Monitor for severe allergic reactions

• Store in a cool, dry, and dark place

Details for Importers and Exporters

Regulatory Documentation Provided

• WHO-GMP, EU-GMP certification

• Certificate of Analysis (COA)

• Certificate of Pharmaceutical Product (COPP)

• CTD/DMF dossiers for international regulatory compliance

• Stability and batch-testing certificates

Custom Packaging & Labeling

• Blister packs, bottles, and strips

• Private labeling options for PCD franchises

• Export-ready packaging ensuring safe transit

Shelf-Life, Storage, and Dosage Form

• Dosage Form: Sublingual tablet

• Strength: 1mg

• Shelf-Life: 24–36 months

• Storage: Below 30°C, protected from moisture and light

Export Certifications

• WHO-GMP and EU-GMP certified

• ISO 9001:2015 quality management systems

• COPP, COA, CTD/DMF dossiers

• Compliance with international pharmaceutical standards

Target Export Markets

• Europe: Germany, UK, France, Italy, Spain

• Asia: UAE, Saudi Arabia, Malaysia, Philippines

• Africa: South Africa, Nigeria, Egypt, Kenya

• Americas: USA, Canada, Brazil, Mexico

Why is the Most Trusted Manufacturer and Exporter

1. State-of-the-Art Manufacturing

• Advanced, WHO-GMP-certified facilities

• Automated production for consistent quality

• Stringent quality control at every stage

2. Affordable Pricing & Quality Assurance

• Competitive bulk pricing

• High-quality tablets meeting global standards

• Continuous monitoring and batch testing

3. Global Presence & Supply Chain Support

• Exporting to over 40 countries worldwide

• Full logistics and regulatory support for international buyers

• Reliable delivery and PCD franchise assistance

4. Top Exporting Countries

• Europe, Asia, Africa, North America, and Latin America

• Strong partnerships with distributors and hospitals worldwide

Technical Product Specification Table

Call to Action – Partner with Taj Pharma

International buyers, importers, and PCD franchise partners looking for a Buprenorphine Sublingual Tablets 1mg manufacturer in India can benefit from:

• WHO-GMP-certified tablets

• Comprehensive export documentation

• Competitive pricing and reliable global supply

• Timely delivery and dedicated customer service

Contact Taj Pharma:
📍 Address: Taj Pharma Ltd, Vapi, Gujarat, India
🌐 Website: www.tajpharma.com
📧 Email: info@tajpharma.com
📞 Phone:+91 84484 44095 (Gen. Enq. 01)

Top 20 FAQs

1. What is Buprenorphine Sublingual Tablets 1mg used for?
   Pain management and opioid withdrawal.

2. Who manufactures it in India?
   Taj Pharma Ltd, Vapi, Gujarat.

3. Dosage form and strength?
   Sublingual tablet, 1mg.

4. How does Buprenorphine work?
   Partial opioid agonist reducing pain and preventing withdrawal.

5. Common side effects?
   Dizziness, insomnia, nausea, drowsiness, constipation.

6. Severe side effects?
   Rare; allergic reactions, respiratory depression.

7. Can it be taken with alcohol?
   No, avoid alcohol while taking this medication.

8. Storage conditions?
   Below 30°C, dry, away from light.

9. Shelf life?
   24–36 months.

10. Private labeling available?
    Yes, for PCD franchise and distributors.

11. Certifications provided?
    WHO-GMP, EU-GMP, ISO 9001:2015.

12. Is it safe during pregnancy?
    Only under strict medical supervision.

13. Export availability?
    Yes, globally to Europe, Asia, Africa, and the Americas.

14. Documentation included?
    COPP, COA, CTD/DMF, stability reports.

15. How should missed doses be handled?
    Take as soon as remembered; do not double next dose.

16. Who should use this medication?
    Patients with moderate to severe pain or opioid dependence.

17. Can it interact with other medications?
    Consult a doctor before combining with other drugs.

18. Lifestyle considerations?
    Avoid driving until aware of sedative effects.

19. PCD franchise support available?
    Yes, with full export documentation.

20. How to place an order?
    Contact Taj Pharma via website, email, or phone.

Buprenorphine Sublingual Tablets 1mg from Taj Pharma Ltd, India are a trusted choice for pain management and opioid withdrawal therapy.

With WHO-GMP certification, international compliance, competitive pricing, and global supply chain support, Taj Pharma is the preferred partner for importers, distributors, and PCD franchises worldwide.

Partner with Taj Pharma today to access high-quality Buprenorphine Sublingual Tablets 1mg, regulatory support, and reliable global supply.