Dabigatran Etexilate Mesilate Capsules 110mg 

Dabigatran Etexilate Mesilate Capsules 110mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Dabigatran Etexilate Mesilate Capsules 110mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1.Dabigatran Etexilate Mesilate Capsules 110mg
Each hard Cellulose Capsule contains:
Dabigatran Etexilate Mesilate 126.83mg
Equivalent to
Dabigatran Etexilate……………….110mg
Excipients……………………………….q.s.
Approved colours 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 & SCHEDULE:

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

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

Dosage: As directed by the Physician.

Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer in India

We understand that buyers searching for a Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer in India require more than a product name and quotation. They need a pharmaceutical partner capable of supporting commercial procurement with appropriate product information, documentation, packaging coordination, and supply planning.

Dabigatran etexilate belongs to the direct oral anticoagulant category. The active metabolite, dabigatran, inhibits thrombin, an enzyme central to coagulation. Current European regulatory information confirms that 110mg dabigatran etexilate capsules are used for several thromboembolic indications, depending on the specific approved product and patient population.

We position Taj Medico as an India-based pharmaceutical manufacturer, supplier, and exporter associated with Vapi, Gujarat, providing a sourcing channel for domestic and international pharmaceutical businesses.

Dabigatran Etexilate Mesilate Capsules 110mg Supplier from Vapi, Gujarat

As a Dabigatran Etexilate Mesilate Capsules 110mg Supplier, we understand the importance of consistency throughout the procurement cycle. Buyers may require specific quantities, packaging configurations, destination-market documentation, product specifications, and shipment schedules.

Vapi, Gujarat, is an established pharmaceutical and industrial location. From this base, we serve pharmaceutical procurement requirements for buyers evaluating Indian suppliers.

For businesses searching for Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer Vapi, Gujarat, we recommend confirming the exact manufacturing arrangement, current product availability, regulatory status, certificates, and commercial terms before placing an order.

Global Demand for Dabigatran 110mg Capsules

The international market for anticoagulant medicines is driven by the ongoing need to manage thromboembolic conditions. Dabigatran etexilate is an established direct oral anticoagulant, and regulatory agencies maintain detailed product information concerning its approved uses, precautions, and quality requirements.

The EMA’s current product-specific guidance specifically addresses bioequivalence for dabigatran etexilate hard capsules in 75mg, 110mg, and 150mg strengths, highlighting the technical importance of demonstrating appropriate pharmaceutical equivalence for generic products.

This makes quality-focused manufacturing, analytical control, documentation, and regulatory preparedness particularly relevant for pharmaceutical buyers.

Dabigatran Etexilate Mesilate Capsules 110mg Export from India

We support inquiries from international buyers seeking Dabigatran Etexilate Mesilate Capsules 110mg export from India. Export transactions should be evaluated according to the regulatory requirements of both the exporting country and the destination market.

Depending on the country, importers may require documentation such as:

• Certificate of Analysis (CoA)
• Product specification
• Batch information
• Manufacturing documentation
• Certificate of Pharmaceutical Product (where applicable)
• Stability information
• Product registration documentation
• Packaging and labeling details
• Commercial invoice and shipping documentation
• Country-specific regulatory documents
• CTD or other dossier documentation where required

The exact documents available and required should be confirmed for each product and destination.

Regulatory Documentation for Pharmaceutical Importers and Buyers

We recognize that professional pharmaceutical importers frequently conduct detailed supplier qualification before purchasing medicinal products. A buyer may request information about the product, manufacturing site, quality-control procedures, stability, packaging, labeling, and regulatory authorization.

For markets requiring a CTD dossier, documentation should be prepared according to the relevant regulatory framework. Similarly, a Certificate of Pharmaceutical Product (CPP/COPP) may be required in certain regulatory pathways.

Claims regarding WHO-GMP, EU-GMP, or other certifications should always be verified against current certificates applicable to the specific manufacturing facility and product. We do not recommend assuming that a certification applies merely because a supplier operates in the pharmaceutical industry.

Custom Packaging and Labeling for Dabigatran 110mg

Packaging is an important consideration for pharmaceutical exporters. We work with buyers to evaluate packaging requirements according to the intended market, product configuration, and regulatory specifications.

Potential requirements can include:

Primary packaging: Capsules may be supplied using packaging configurations appropriate to the approved product.

Secondary packaging: Cartons and printed materials can be designed according to approved specifications where permitted.

Labeling: Destination-country requirements may determine the language, mandatory information, storage instructions, batch details, expiry information, and other label elements.

Export packaging: International shipments require packaging suitable for transportation and handling while maintaining product integrity.

Any custom packaging or private-label arrangement should be confirmed against the relevant regulatory authorization before production.

Shelf Life, Storage and Dosage Form

Dabigatran Etexilate Mesilate Capsules 110mg are an oral hard-capsule dosage form. Exact shelf life and storage requirements should be taken from the approved product specification and packaging supplied for the particular product.

The EMA product information for Pradaxa identifies 110mg as a hard-capsule presentation containing dabigatran etexilate as the mesilate salt.

Dabigatran capsules should be handled according to their approved packaging and storage instructions. Patients should also follow the product-specific instructions provided by their healthcare professional and package leaflet.

Technical Product Specification – Dabigatran Etexilate Mesilate Capsules 110mg

Why Choose Taj Medico for Dabigatran Etexilate Mesilate Capsules 110mg?

We aim to provide pharmaceutical buyers with a professional sourcing experience centered on product quality, commercial transparency, documentation, and supply coordination.

Quality-Oriented Pharmaceutical Supply

Quality assurance is fundamental when supplying anticoagulant medicines. We focus on appropriate product specifications, documentation, batch-related information, and controlled pharmaceutical supply processes.

Competitive Pharmaceutical Pricing

We understand the importance of commercial competitiveness for importers, distributors, hospitals, pharmaceutical companies, and institutional buyers. Pricing can depend on quantity, packaging, destination, documentation, freight, and other commercial conditions.

Supply Chain Support

International pharmaceutical orders require coordination across procurement, documentation, packaging, logistics, and import requirements. We work with buyers to establish the requirements before commercial confirmation.

International Buyer Support

We serve inquiries from pharmaceutical businesses across multiple regions and evaluate orders according to destination-country requirements.

Top 20 Export Markets for Pharmaceutical Buyers

India , Bangladesh, Nepal, Sri Lanka, Vietnam, Philippines, Cambodia, Nigeria, Kenya, Ghana, Egypt, Ethiopia, Morocco, Peru, Colombia, Ecuador, Bolivia , Ukraine, Uzbekistan, Kazakhstan

Dabigatran Capsules 110mg Manufacturer for PAN India Supply

We also support businesses searching for a Dabigatran Etexilate Mesilate Capsules 110mg PAN India Manufacturer and Supplier. Pharmaceutical distribution within India requires dependable coordination between manufacturers, distributors, wholesalers, hospitals, pharmacies, and other authorized channels.

Mumbai, Maharashtra, remains an important commercial and pharmaceutical distribution center. Therefore, businesses searching for Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer from Mumbai can also evaluate manufacturers and suppliers based in other Indian pharmaceutical hubs such as Gujarat.

For buyers specifically searching for Dabigatran Etexilate Mesilate Capsules 110mg Best Price in Mumbai Maharashtra, quotations should be compared using the complete commercial package rather than unit price alone.

Dabigatran Etexilate Mesilate Capsules 110mg PCD Pharma Franchise

We can also address business inquiries relating to a Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer Supplier and PCD Pharma Franchise.

Potential franchise partners should evaluate territory availability, product authorization, pricing, minimum order quantities, packaging, promotional requirements, documentation, and distribution responsibilities.

Because Dabigatran is a prescription anticoagulant, all marketing and promotional activities must remain consistent with approved indications and applicable pharmaceutical advertising regulations.

Dabigatran 110mg Safety Information

Dabigatran is an anticoagulant and can increase the risk of bleeding. Patients should take it only according to their healthcare professional’s instructions. Treatment decisions can depend on factors including kidney function, age, other medicines, bleeding risk, and the clinical indication.

Patients should not independently discontinue anticoagulant treatment. They should inform their healthcare professional before surgery, dental procedures, invasive procedures, or spinal procedures.

The current EMA product information contains detailed warnings, precautions, contraindications, interactions, and dosing recommendations for dabigatran products.

Top 20 FAQs About Dabigatran Etexilate Mesilate Capsules 110mg

1. What are Dabigatran Etexilate Mesilate Capsules 110mg?

They are oral hard capsules containing 110mg-strength dabigatran etexilate as the mesilate salt, an anticoagulant prodrug converted to active dabigatran.

2. What is Dabigatran used for?

Approved uses can include prevention of stroke/systemic embolism in eligible patients with non-valvular atrial fibrillation and treatment or prevention of DVT and PE, depending on the product and market.

3. Is Dabigatran a blood thinner?

Yes. It is commonly described as a blood thinner or anticoagulant, although technically it works by directly inhibiting thrombin.

4. What is the 110mg strength used for?

The 110mg strength has specific approved uses and dosing regimens that depend on the indication and patient characteristics.

5. Is Dabigatran available in India?

Dabigatran etexilate products may be marketed in India subject to applicable regulatory authorization and product registration.

6. Who manufactures Dabigatran Capsules in India?

We supply pharmaceutical buyers seeking Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer in India, subject to product availability and regulatory requirements.

7. Where is Taj Medico located?

Taj Medico is associated with Vapi, Gujarat, India.

8. Can international buyers import Dabigatran from India?

Importability depends on the destination country’s pharmaceutical regulations, product registration, import authorization, and applicable documentation.

9. Can custom packaging be arranged?

Packaging requirements can be discussed according to the approved product, destination-market regulations, and commercial requirements.

10. What documents can pharmaceutical buyers request?

Depending on the market, buyers may require CoA, product specifications, manufacturing information, regulatory documents, stability information, and other supporting documentation.

11. Is Dabigatran suitable for everyone?

No. Appropriate use depends on the patient’s medical circumstances and approved prescribing information.

12. Can Dabigatran cause bleeding?

Yes. Increased bleeding is an important safety consideration with anticoagulant treatment.

13. Does kidney function matter with Dabigatran?

Yes. Kidney function is clinically important because dabigatran exposure is substantially affected by renal function.

14. Can patients stop Dabigatran suddenly?

Patients should not discontinue prescribed anticoagulant therapy without medical advice because interruption may increase thromboembolic risk.

15. Is Dabigatran prescription-only?

It is a prescription anticoagulant in many markets, and its use should be supervised by an appropriate healthcare professional.

16. Can Dabigatran interact with other medicines?

Yes. Certain medicines can affect dabigatran exposure or increase bleeding risk, so healthcare professionals should review concomitant medicines.

17. Is Dabigatran available for export from India?

Export arrangements depend on product authorization, destination-country regulations, documentation, and commercial requirements.

18. Can distributors request bulk quantities?

Commercial buyers can submit their required quantity and destination so appropriate supply arrangements can be evaluated.

19. Does Taj Medico offer PAN India supply?

We address inquiries from pharmaceutical buyers throughout India, with supply subject to product availability and commercial terms.

20. How can global buyers request a quotation?

Buyers can provide the required quantity, destination country, packaging requirements, and documentation needs to initiate a commercial inquiry.

 Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer and Exporter in India

We serve pharmaceutical businesses searching for a dependable Dabigatran Etexilate Mesilate Capsules 110mg Manufacturer in India, supplier, exporter, and PCD Pharma Franchise partner.

With our association with Vapi, Gujarat, we support domestic and international procurement requirements involving product information, commercial quotations, packaging discussions, documentation, and supply coordination.

For global pharmaceutical buyers, successful procurement depends on verified product quality, appropriate regulatory documentation, destination-market compliance, reliable logistics, and transparent commercial communication. We therefore encourage importers and distributors to provide complete product and destination requirements before finalizing an order.

Dabigatran Etexilate Mesilate Capsules 110mg are prescription anticoagulants and should be supplied and used according to applicable regulatory requirements and professional medical guidance. For commercial inquiries, buyers can request information regarding Dabigatran Etexilate Mesilate Capsules 110mg export from India, bulk supply, packaging, documentation, and destination-market requirements.