Molecules / Dabigatran Etexilate

Dabigatran Etexilate API manufacturers

CAS 211915-06-9 ATC B01AE07 Updated 9 July 2026
28
manufacturers with an active filing 25 of them hold a US DMF or a CEP
$981.13
median export price per kg $760.00 to $1279.13 · 10 exporters · 2023
6
shortage records on file across 2 countries
378
finished-dose makers across 34 regulators
Showing 20 of 28 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Apotex

Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Dr. Reddy's Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dabigatran etexilate, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Hetero

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dabigatran etexilate, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Biocon

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Lupin

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Micro Labs

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Lee Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2021. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Zydus Lifesciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Alembic Pharmaceuticals

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Piramal Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Alkem Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2014. Its GMP is recognised in 21 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

MSN Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Alivus Life Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dabigatran etexilate, filing since 2022. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Boehringer Ingelheim Pharma Gmbh

Germany
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for dabigatran etexilate. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
42 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
15

Jiangxi Synergy Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2018. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Solara Active Pharma Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2016. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2014. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Srini Pharmaceuticals

India
Makes the API

Holds one active US DMF for dabigatran etexilate, filing since 2020. Its 2019 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Yabao Pharmaceutical Group

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dabigatran etexilate, filing since 2020. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Changzhou Pharmaceutical Factory

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for dabigatran etexilate, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

25 more manufacturers hold filings for dabigatran etexilate

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

BioconLupinMicro LabsLee PharmaZydus LifesciencesAlembic PharmaceuticalsPiramal PharmaAlkem LaboratoriesMSN LaboratoriesAlivus Life SciencesBoehringer Ingelheim Pharma GmbhJiangxi Synergy PharmaceuticalSolara Active Pharma SciencesApitoria PharmaSrini PharmaceuticalsYabao Pharmaceutical GroupChangzhou Pharmaceutical Factory
Open the full list with a free account

Finished-dose makers (29)

Viatris United States Zentiva, k.s Czech Republic Glenmark Pharmaceuticals s.r.o Czech Republic Olpha Latvia Sandoz Switzerland “Gedeon Richter” Hungary Laboratorios Liconsa Spain Orion Finland STADA Arzneimittel Germany Towa Pharmaceutical Europe, S.L Spain Boehringer Ingelheim Animal Health Usa United States Pharmathen Greece Aurobindo Pharma India Marcyrl Pharmaceutical Industries Egypt Zaklady Farmaceutyczne Polpharma Poland TEVA Israel Boehringer Ingelheim Do Brasil Quimica E Farmaceutica Ltda Brazil Mylan Laboratories Limited [Otl] India Pine Pharmaceuticals Pakistan Rowa Pharmaceuticals Ireland

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2023. These are export values rather than contract prices for regulated-market grade material, which are higher.

Map dabigatran etexilate for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Price history 1 yrs Shortages 6 Recalls 8 Finished dose 29 Contract mfrs 0

By country

India 28 China 6