Molecules / Mesalamine / India

Mesalamine API manufacturers in India

CAS 89-57-6 ATC A07EC02 Updated 9 July 2026
24
India-based manufacturers with an active filing of 30 worldwide
$44.10
median export price per kg, all origins $36.33 to $55.70 · 41 exporters · 2025
Showing 13 of 24 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Divi's Laboratories

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

Holds one valid CEP for mesalamine, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
2 markets
04

MSN Life Sciences

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

Holds one valid CEP for mesalamine, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
07

Maithri Drugs

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

Holds one valid CEP for mesalamine, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
08

Alkem Laboratories

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

Its GMP is recognised in 21 markets.

US DMF
None on file
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
09

Amoli Organics

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

Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
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
10

Apitoria Pharma

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

Its 2025 FDA inspection closed as VAI.

US DMF
None on file
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
11

CTX Lifesciences

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

Holds one valid CEP for mesalamine, filing since 2021. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
12

Dasami Lab

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

Its 2025 FDA inspection closed as VAI.

US DMF
None on file
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
13

Optimus Drugs

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

Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

11 more manufacturers in India hold filings for mesalamine

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 Mesalamine 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.

Map mesalamine 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.

All Mesalamine manufacturers