Molecules / Dabigatran Etexilate Mesilate

Dabigatran Etexilate Mesilate API manufacturers

Updated 9 July 2026
12
manufacturers with an active filing 12 of them hold a US DMF or a CEP
4
shortage records on file across 1 countries
53
finished-dose makers across 6 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
View profile
02

Biocon

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
How this listing is sourced EDQM certificate database
View profile
03

Alembic Pharmaceuticals

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

Holds 2 valid CEPs for dabigatran etexilate mesilate, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced EDQM certificate database
View profile
04

MSN Laboratories

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

Holds 2 valid CEPs for dabigatran etexilate mesilate, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
View profile
05

Piramal Pharma

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced EDQM certificate database
View profile
06

Zydus Lifesciences

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced EDQM certificate database
View profile
07

Zhejiang Tianyu Pharmaceutical

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
08

Krka

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its GMP is recognised in 5 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced EDQM certificate database
View profile
09

Metrochem API

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2026. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
10

Aurore Life Sciences

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
11

Hikal

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
12

Zhejiang Huahai Pharmaceutical

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

Holds one valid CEP for dabigatran etexilate mesilate, filing since 2025. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile

9 more manufacturers hold filings for dabigatran etexilate mesilate

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

Open the full list with a free account

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

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