Molecules / Indomethacin

Indomethacin API manufacturers

CAS 53-86-1 ATC C01EB03 · Other cardiac preparations Updated 9 July 2026
9
manufacturers with an active filing 9 of them hold a US DMF or a CEP
$51.86
median export price per kg $40.60 to $96.84 · 21 exporters · 2025
14
shortage records on file across 2 countries
553
finished-dose makers across 48 regulators
Showing 9 of 9 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Gland Pharma

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

Holds 2 active US DMFs for indomethacin, filing since 2011. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Hetero

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

Holds 2 active US DMFs for indomethacin, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

CSPC Ouyi Pharmaceutical

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

Holds one active US DMF for indomethacin, filing since 2008. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 11 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
11 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Solara Active Pharma Sciences

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

Holds one active US DMF for indomethacin, filing since 2009. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for indomethacin, filing since 1978. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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
07

Aurore Life Sciences

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

Holds one active US DMF for indomethacin, filing since 2022. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Agno Pharma Usa

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

Holds one active US DMF for indomethacin, filing since 2024.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

6 more manufacturers hold filings for indomethacin

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

Contract manufacturers (1)

Contract manufacturers make to order rather than holding their own filing for this molecule.

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
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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By country

Export price by year

Year Median Exporters
2025 $51.86 21
2024 $47.59 19
2022 $59.18 16

US dollars per kilogram, customs export unit values.