Molecules / Dapagliflozin / India

Dapagliflozin API manufacturers in India

CAS 461432-26-8 ATC A10BK01 Updated 9 July 2026
35
India-based manufacturers with an active filing of 46 worldwide
$1005.99
median export price per kg, all origins $688.37 to $1880.62 · 42 exporters · 2025
Showing 19 of 35 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

MSN Laboratories

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

Holds 4 active US DMFs for dapagliflozin, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 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 3 active US DMFs for dapagliflozin, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
3 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

Harman Finochem

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

Holds one active US DMF for dapagliflozin, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
3 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 2 active US DMFs for dapagliflozin, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
2 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 APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dapagliflozin, filing since 2017. 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

Macleods Pharmaceuticals

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

Holds one active US DMF for dapagliflozin, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Micro Labs

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

Holds one active US DMF for dapagliflozin, filing since 2017. 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
08

Lee Pharma

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

Holds one active US DMF for dapagliflozin, filing since 2023. 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
09

Alembic Pharmaceuticals

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

Holds 2 active US DMFs for dapagliflozin, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
2 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

Laurus Labs

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

Holds 2 active US DMFs for dapagliflozin, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

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

Piramal Pharma

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

Holds one active US DMF for dapagliflozin, filing since 2018. 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
12

USV

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

Holds one active US DMF for dapagliflozin, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Granules India

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

Holds 2 active US DMFs for dapagliflozin, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

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

Zydus Lifesciences

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

Holds 2 active US DMFs for dapagliflozin, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
2 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
15

Alivus Life Sciences

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

Holds 2 active US DMFs for dapagliflozin, filing since 2017. 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
16

Amoli Organics

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

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

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Raks Pharma

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

Holds one active US DMF for dapagliflozin, filing since 2017. 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
18

Ami Lifesciences

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

Holds 2 active US DMFs for dapagliflozin, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 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
19

Cohance Lifesciences

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

Holds 2 active US DMFs for dapagliflozin, filing since 2019. 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

16 more manufacturers in India hold filings for dapagliflozin

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

This page filters the worldwide Dapagliflozin 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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