Molecules / Linagliptin / India

Linagliptin API manufacturers in India

CAS 668270-12-0 ATC A10BH05 Updated 9 July 2026
27
India-based manufacturers with an active filing of 36 worldwide
$886.88
median export price per kg, all origins $540.00 to $2310.00 · 65 exporters · 2025
Showing 15 of 27 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Biocon

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

Holds 2 active US DMFs for linagliptin, filing since 2021. 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
02

Macleods Pharmaceuticals

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

Holds one active US DMF for linagliptin, filing since 2018. 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
03

Dr. Reddy's Laboratories

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

Holds one active US DMF for linagliptin, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 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
04

Lee Pharma

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

Holds one active US DMF for linagliptin, 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
05

Harman Finochem

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

Holds one active US DMF for linagliptin, filing since 2023. 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
06

Alembic Pharmaceuticals

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

Holds 2 active US DMFs for linagliptin, 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
07

Centaur Pharmaceuticals

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

Holds one active US DMF for linagliptin, filing since 2022. 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
08

Apitoria Pharma

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

Holds one active US DMF for linagliptin, filing since 2015. 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
09

Granules India

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

Holds 2 active US DMFs for linagliptin, filing since 2024. 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
10

Zydus Lifesciences

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

Holds one active US DMF for linagliptin, filing since 2015. 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
11

Alivus Life Sciences

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

Holds 2 active US DMFs for linagliptin, filing since 2014. 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
12

Morepen Laboratories

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

Holds 2 active US DMFs for linagliptin, filing since 2019. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

CTX Lifesciences

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

Holds one active US DMF for linagliptin, filing since 2025. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Honour Lab

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

Holds 2 active US DMFs for linagliptin, filing since 2015. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

MSN Pharmachem

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

Holds 4 active US DMFs for linagliptin, filing since 2014. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
4 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

12 more manufacturers in India hold filings for linagliptin

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 Linagliptin 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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