WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Pradaxa (dabigatran etexilate) is an oral direct thrombin inhibitor capsule, taken twice daily without routine coagulation monitoring, and it is bought as originator Pradaxa or as a registered generic depending on the destination.

M Care Exports supplies Pradaxa (dabigatran etexilate), made by Boehringer Ingelheim, and Indian-made generic dabigatran capsules, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Pradaxa 75 mg, 110 mg or 150 mg, tell us the destination and the registration route, and we quote the brand or a generic that your regulator accepts.

WhatsApp a dabigatran etexilate enquiry → Send enquiry by form
WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Dabigatran etexilate exporter and bulk supplier from India.

"We need a partner for dabigatran" is a typical importer enquiry. M Care is a merchant-exporter: we quote Pradaxa capsules and Indian-made generics (for example Dabigat and Dabigo lines) against your specification. The quote depends on originator or generic, strength, pack type (bottle or blister), quantity and what your regulator will register. Generic lines are offered only for destinations whose registration accepts them. Dabigatran is a room-temperature product with no cold chain, so the logistics question is moisture protection and shelf life at arrival, not temperature lanes.

Source

WHO-GMP-certified Indian manufacturing line, named on every quote.

Minimum order

No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.

Pricing

On request. Indicative FOB or CIF quote, formal proforma on confirmation.

Incoterms

EXW, FOB, CIF, CIP or DAP.

Payment

Letter of credit (sight or usance) and telegraphic transfer.

Documentation

WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.

Shelf-life

Minimum remaining shelf-life agreed per order and confirmed on the proforma.

Response

Availability and CoPP status within two working days; pre-alert documents before dispatch.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Direct thrombin inhibitor (oral anticoagulant), sourced and documented for export.

Dabigatran etexilate is a prodrug of dabigatran, a direct thrombin inhibitor. Per the FDA label, Pradaxa capsules are indicated to reduce the risk of stroke and systemic embolism in adults with non-valvular atrial fibrillation, to treat deep venous thrombosis (DVT) and pulmonary embolism (PE) after 5 to 10 days of parenteral anticoagulant, to reduce recurrence of DVT and PE, to prevent DVT and PE after hip replacement surgery, and to treat and reduce recurrence of venous thromboembolism in paediatric patients aged 8 to under 18 years. The EU SmPC splits the indications by strength: the 150 mg capsule carries atrial fibrillation, DVT/PE and paediatric VTE; the 110 mg capsule carries those plus post-operative prevention after hip or knee replacement; and the 75 mg capsule carries the post-operative indication and paediatric VTE. Capsules come in 75 mg, 110 mg and 150 mg. In the US there is also a Pradaxa oral pellets presentation for children aged 3 months to under 12 years, which is a separate dosage form that must not be swapped milligram for milligram with capsules.

Active ingredient

Dabigatran etexilate mesilate. Direct thrombin inhibitor (oral anticoagulant).

Forms and strengths

75 mg hard capsule; 110 mg hard capsule; 150 mg hard capsule.

Indications

Dabigatran etexilate, an oral direct thrombin inhibitor indicated for stroke prevention in non-valvular atrial fibrillation and for treatment and prevention of DVT and PE. Supplied as originator Pradaxa and Indian-made generic capsules to regulated and semi-regulated markets outside India.

Administration

Oral. Hard capsule.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Buyers are hospital pharmacists and cardiology or haematology formulary leads, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Pradaxa 150 mg" or "We need a partner for dabigatran capsules for a tender". Dabigatran is dispensed to outpatients on long-term therapy for atrial fibrillation, so volume buyers care about continuity of supply, pack type and remaining shelf life at delivery. Each destination has its own registration route, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on dabigatran etexilate.

Three points matter at the counter. First, dosing is strength-specific. The EU SmPC gives 150 mg twice daily for atrial fibrillation and recommends 110 mg twice daily in patients aged 80 or over or on verapamil, with a case-by-case choice between 150 mg and 110 mg for ages 75 to 80, moderate renal impairment (CrCl 30 to 50 mL/min) or gastritis, oesophagitis or reflux. CrCl below 30 mL/min is a contraindication in the EU. The US label instead gives 75 mg twice daily for CrCl 15 to 30 mL/min. Second, handling: capsules must not be broken, chewed or opened. The US label notes higher bioavailability if the pellets are taken alone, and the EU SmPC warns that opening the capsule may increase bleeding risk. Per the US label, an opened bottle must be used within 4 months, the capsules stay in the original bottle or package against moisture, and they must not go into pill boxes or organisers. Third, a specific reversal agent, idarucizumab, exists for adults. The boxed warnings cover premature discontinuation and spinal or epidural haematoma. Mechanical prosthetic heart valves are a contraindication.

Regulatory & quality

The documentation pack a regulator actually asks for.

Dabigatran needs no cold chain. The US label sets storage at 20 to 25 C with excursions to 15 to 30 C; the EU SmPC specifies protection from moisture, a shelf life of 3 years in blister or bottle, and use within 4 months of opening a bottle. For a bulk order that means checking remaining shelf life on arrival and keeping stock sealed in original packs. For originator Pradaxa the EU marketing authorisation holder is Boehringer Ingelheim International GmbH, and the product has been authorised in the EU since March 2008. For generics, the EMA lists Dabigatran Etexilate Accord as a generic of Pradaxa, authorised in May 2023, and the FDA has approved generic dabigatran etexilate capsules, so buyers can see both originator and generic supply. M Care documentation covers batch certificates of analysis, CDSCO export documents and destination-aligned dossier support where the regulator requires it. The manufacturer's WHO-GMP status is confirmed per line before quoting.

CoA and MoA, per batch

Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.

CoPP, WHO-GMP, MFG licence

Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.

CTD Module 3

Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.

Pack insert, labels, artwork

Destination-language patient information and labelling to the local regulator's standard, locked before shipment.

Pharmacovigilance

A named PV contact arranged in the destination market where the registration requires one.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for dabigatran etexilate.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Dabigatran etexilate supply, the specific questions.

Is there a generic Pradaxa, and what is the situation in the US, EU and India?

Yes. In the US, the FDA's 2023 first-generic approvals list includes Apotex dabigatran etexilate capsules in 75, 110 and 150 mg, with Pradaxa as the reference product. In the EU, the EMA lists Dabigatran Etexilate Accord as a generic of Pradaxa, with the marketing authorisation issued on 26 May 2023. For India, we cite no Indian regulator page here; what we can say is that Indian-made dabigatran lines (for example Dabigat and Dabigo) are on the M Care supplier roster for destinations whose registration accepts them. We do not claim any of these brands is registered in a given destination.

What is the Pradaxa price, and what sets it for an importer?

We do not publish a Pradaxa price, because the landed cost depends on the destination. The main drivers are originator Pradaxa or a generic, strength and pack type (bottle or blister), order quantity, the registration route in your country, shelf life required at arrival, and the Incoterms. Dabigatran needs no cold chain, which removes one cost line that biologics carry. M Care Exports quotes per destination. Send the strength, quantity and port, and we return an offer.

Pradaxa vs Eliquis: which one do tenders ask for?

They are different molecules and are not interchangeable on a milligram basis. Dabigatran is a direct thrombin inhibitor with a specific reversal agent, idarucizumab, described in the Pradaxa label. Eliquis is apixaban, which M Care also quotes as a separate enquiry. The choice is made by the prescriber and the formulary, not by the supplier. What we can tell a tender desk is the supply picture for dabigatran: originator and generic capsules, room-temperature storage, and registration status per destination. Please send the formulary wording you must match.

What are the Pradaxa 75 mg, 110 mg and 150 mg capsules used for?

In the EU SmPC, the 150 mg capsule is for stroke prevention in non-valvular atrial fibrillation, for treating and preventing recurrence of DVT and PE in adults, and for paediatric VTE. The 110 mg capsule covers those uses and also post-operative prevention after hip or knee replacement, and it is the reduced dose for patients aged 80 or over or on verapamil. The 75 mg capsule is listed for the post-operative prevention indication and for paediatric VTE. Labelling differs by country, so we confirm the destination label before quoting a strength.

Is Pradaxa a tablet, and how should it be dosed?

Pradaxa is a hard capsule, not a tablet, and it must be swallowed whole. For atrial fibrillation the EU SmPC gives 150 mg twice daily, with 110 mg twice daily recommended for patients aged 80 or over or on verapamil. Renal function is estimated with the Cockcroft-Gault method, and CrCl below 30 mL/min is a contraindication in the EU. The US label differs and gives 75 mg twice daily for CrCl 15 to 30 mL/min. Dosing is the prescriber's decision, and our role is to supply to the destination's label.

Can M Care supply both originator Pradaxa and Indian generics to Africa, the GCC or the UK?

Yes. M Care resells originator brands as well as generics. We can quote Pradaxa capsules and Indian-made dabigatran generics, and we say clearly which one each offer is. The route differs by market, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA for the UK, so we confirm what your regulator accepts first. Because there is no cold chain, shipping is standard ambient freight with moisture-protected packs. M Care is a merchant-exporter, not a manufacturer.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.

This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.

Dabigatran etexilate enquiry

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