Dabigatran Etexilate Mesilate Capsules 110mg

Dabigatran Etexilate Mesilate Capsules 110mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Dabigatran Etexilate Mesilate Capsules 75mg
2. Dabigatran Etexilate Mesilate Capsules 110mg
3. Dabigatran Etexilate Mesilate Capsules 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Dabigatran Etexilate Mesilate Capsules 75mg
Each hard Cellulose Capsule contains:
Dabigatran Etexilate Mesilate 86.48mg
Equivalent to
Dabigatran Etexilate……………….75mg
Excipients……………………………….q.s.
Approved colors used in capsule shells.

2. Dabigatran Etexilate Mesilate Capsules 110mg
Each hard Cellulose Capsule contains:
Dabigatran Etexilate Mesilate 126.83mg
Equivalent to
Dabigatran Etexilate……………….110mg
Excipients……………………………….q.s.
Approved colors used in capsule shells.

3. Dabigatran Etexilate Mesilate Capsules 150mg
Each hard Cellulose Capsule contains:
Dabigatran Etexilate Mesilate 172.95mg
Equivalent to
Dabigatran Etexilate……………….150mg
Excipients……………………………….q.s.
Approved colors used in capsule shells.

THERAPEUTIC INDICATIONS:

Dabigatran is used to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem called nonvalvular atrial fibrillation. Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery.

CAUTION & WARNING:

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

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A CARDIOLOGISTS, ORTHOPADIC SURGEONS, NEUROLOGISTS, INTENSIVE CARE SPECIALISTS, SURGEONS AND HEMATOLOGIST ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Protect from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction: Understanding Dabigatran Etexilate Mesilate Capsules 110mg

Dabigatran Etexilate Mesilate Capsules 110mg are a vital anticoagulant (blood thinner) used globally to prevent and treat blood clots, reduce stroke risk, and protect against heart attacks. The medicine works by inhibiting thrombin, a critical enzyme involved in clot formation. By doing so, it effectively prevents dangerous clots in veins, lungs, brain, and heart.

Taj Pharma, the most trusted Dabigatran Etexilate Mesilate Capsules 110mg manufacturer in India, ensures each capsule meets stringent international standards of quality, purity, and efficacy. This formulation is widely used for patients with atrial fibrillation, and post-operative care in knee and hip replacement surgeries.

The growing global incidence of cardiovascular diseases and venous thromboembolism has made Dabigatran Etexilate Mesilate Capsules 110mg an essential part of modern medical therapy. As a result, its global demand is on a consistent rise, especially in emerging markets.

What is Dabigatran Etexilate Mesilate Capsules 110mg?

Dabigatran Etexilate Mesilate Capsules 110mg belong to the Direct Thrombin Inhibitor (DTI) class of drugs. Unlike traditional anticoagulants like warfarin, Dabigatran does not require routine INR monitoring, offering convenience and consistent efficacy for long-term use.

• Brand Equivalent: Pradaxa

• Therapeutic Category: Anticoagulant / Antithrombotic

• Dosage Form: Capsule

• Strength: 110mg

• Route of Administration: Oral

Taj Pharma’s Dabigatran Etexilate Mesilate Capsules 110mg are produced under WHO-GMP-certified facilities in Vapi, Gujarat, India, ensuring global export compliance with EU-GMP equivalent standards.

Clinical Uses and Benefits

• Prevents Stroke and Systemic Embolism: Especially in patients with non-valvular atrial fibrillation.

• Reduces Risk of Deep Vein Thrombosis (DVT): Common after orthopedic surgeries.

• Prevents Pulmonary Embolism (PE): Life-threatening clots in the lungs.

• Maintains Smooth Blood Flow: Reduces clotting risks during chronic heart conditions.

Taj Pharma’s Dabigatran Etexilate Mesilate Capsules 110mg are trusted by doctors worldwide for their consistent pharmacokinetic performance, bioavailability, and stringent batch quality control.

Why Choose Dabigatran Etexilate Mesilate Capsules 110mg from Taj Pharma India?

Taj Pharma Ltd India is a WHO-GMP, ISO 9001:2015, and COPP certified pharmaceutical company renowned for its excellence in cardiovascular and anticoagulant drug manufacturing. Located in Vapi, Gujarat, the company delivers quality-driven formulations to over 45 countries.

Taj Pharma’s Quality Highlights

• 100% WHO-GMP Compliant Manufacturing

• EU-GMP Equivalent Quality Assurance Systems

• Validated Manufacturing & Testing Protocols

• Comprehensive CTD/ACTD Dossiers for Regulatory Submission

• End-to-End Export Support

Each batch of Dabigatran Etexilate Mesilate Capsules 110mg undergoes microbiological, analytical, and stability testing before dispatch.

Detailed Information for Importers, Exporters, and PCD Buyers

Regulatory Documentation Provided

Taj Pharma provides full regulatory support for international registration, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• Certificate of Analysis (COA)

• Stability Data (As per ICH Guidelines)

• CTD/ACTD Dossier

• Master Formula Record (MFR)

• Analytical Method Validation

Custom Packaging & Labeling

Taj Pharma provides customized export packaging and labeling options as per importer’s regulatory requirements. Blister, Alu-Alu, and HDPE bottle formats are available with multi-language labeling.

Shelf Life and Storage

• Shelf Life: 24–36 months

• Storage: Store below 30°C, away from moisture and sunlight.

• Dosage Form: Hard Gelatin Capsules

Export Certifications

• WHO-GMP Certified

• EU-GMP Equivalent Standards

• ISO 9001:2015

• COPP Approved for Multiple Countries

• CTD/ACTD Dossier Ready

Target Export Markets

Taj Pharma is a prominent exporter of Dabigatran Etexilate Mesilate Capsules 110mg to:

• Asia

• Africa

• Middle East

• Latin America

• CIS & Eastern Europe

Key export destinations include Vietnam, Nigeria, Kenya, Myanmar, Philippines, Iraq, Yemen, UAE, and Mexico.

Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

1. Advanced Manufacturing Infrastructure

Taj Pharma’s state-of-the-art manufacturing plant in Vapi, Gujarat, includes:

• Automated encapsulation units

• Dedicated cleanroom facilities

• In-house analytical and microbiology labs

• Zero contamination and cross-contamination policies

2. Quality Assurance and Affordability

Taj Pharma ensures premium quality at globally competitive prices. Each capsule is tested for uniformity, dissolution rate, and purity, meeting stringent Pharmacopeial standards (IP/BP/USP).

3. Global Presence and Supply Chain Support

Taj Pharma maintains a robust international logistics network, offering:

• On-time delivery

• Temperature-controlled shipments

• Assistance with customs documentation

4. Proven Trust Across Continents

The company’s reputation as a WHO-GMP-certified Dabigatran Etexilate Mesilate Capsules 110mg manufacturer in India makes it a preferred partner for government tenders, hospitals, and distributors worldwide.

Top 20 Export 

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Technical Product Specification Table

PAN India & Global Presence

Taj Pharma is a PAN India Manufacturer and Supplier of Dabigatran Etexilate Mesilate Capsules 110mg, offering:

• PCD Pharma Franchise Opportunities

• Contract Manufacturing for Global Companies

• Third-Party Manufacturing for Hospitals and Brands

From Mumbai to Vapi, and across Asia, Africa, and LATAM, Taj Pharma delivers unmatched product reliability, price competitiveness, and export compliance.

Call to Action for Importers and Buyers

Are you looking for a trusted Dabigatran Etexilate Mesilate Capsules 110mg manufacturer, supplier, or exporter in India?

Partner with Taj Pharma Ltd, India’s leading WHO-GMP-certified pharmaceutical company. We ensure affordable, high-quality anticoagulant products that meet international registration and tender requirements.

📞 Contact Taj Pharma Ltd India
Email: info@tajpharma.com
Website: www.tajpharma.com
Manufacturing Unit: Vapi, Gujarat, India
Head Office: Mumbai, Maharashtra, India

Top 20 FAQs  

1. What are Dabigatran Etexilate Mesilate Capsules 110mg used for?
They are anticoagulant capsules used to prevent and treat blood clots, stroke, and heart attack.

2. Who is the top manufacturer in India?
Taj Pharma Ltd, Vapi, Gujarat, is India’s leading WHO-GMP-certified manufacturer.

3. Are these capsules WHO-GMP certified?
Yes, Taj Pharma’s products meet WHO-GMP and ISO 9001:2015 standards.

4. What is the shelf life?
Typically 24–36 months under recommended storage conditions.

5. Is routine blood testing required?
No, unlike warfarin, Dabigatran doesn’t require regular INR tests.

6. What are common side effects?
Stomach upset, bleeding, bruising, and mild headaches.

7. Can it be taken with food?
Yes, with or without food, at the same time daily.

8. Can pregnant women use this medicine?
Consult your physician before use during pregnancy or breastfeeding.

9. What packaging is available?
Alu-Alu, blister, or HDPE bottle packaging.

10. What export documentation is provided?
COA, COPP, CTD Dossier, FSC, and Stability Data.

11. Does Taj Pharma offer private labeling?
Yes, for global distributors and contract manufacturers.

12. Is it available for PCD franchise?
Yes, PAN India PCD franchise opportunities are available.

13. How can importers get registration samples?
By contacting Taj Pharma’s export department.

14. Which markets import this product?
Africa, Asia, Middle East, and Latin America.

15. Does Taj Pharma supply hospital tenders?
Yes, the company supplies both government and NGO tenders globally.

16. What is the dose strength?
110mg (available in 75mg and 150mg on request).

17. How is it stored?
Below 30°C, in a cool, dry environment.

18. Is it available in bulk quantities?
Yes, Taj Pharma supports large-scale export orders.

19. How can I verify certifications?
All certifications are verifiable upon request.

20. How do I contact Taj Pharma?
Through www.tajpharma.com or email at info@tajpharma.com