Molecules / Dabigatran Etexilate Mesilate / India

Dabigatran Etexilate Mesilate API manufacturers in India

Updated 9 July 2026
9
India-based manufacturers with an active filing of 12 worldwide
Showing 9 of 9 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based 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

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
08

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
09

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

How this list is built

This page filters the worldwide Dabigatran Etexilate Mesilate manufacturer list to companies based in India. 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. Read the full method.

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All Dabigatran Etexilate Mesilate manufacturers