Molecules / Diclofenac

Diclofenac API manufacturers

CAS 15307-86-5 ATC D11AX18 · Other dermatological preparations Updated 9 July 2026
27
manufacturers with an active filing 13 of them hold a US DMF or a CEP
$20.00
median export price per kg $12.00 to $38.00 · 57 exporters · 2025
193
shortage records on file across 15 countries
2,374
finished-dose makers across 53 regulators
Showing 20 of 27 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Amoli Organics

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

Holds 5 active US DMFs for diclofenac, filing since 2007. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
5 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
03

Macleods Pharmaceuticals

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

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

Henan Dongtai Pharm

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

Holds 2 active US DMFs for diclofenac, filing since 2011. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Dipharma Francis

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

Holds 2 active US DMFs for diclofenac, filing since 1986. 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
08

Cheng Fong Chemical

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

Holds 2 active US DMFs for diclofenac, filing since 1989. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Kreative Organics

India
Makes the API

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

US DMF
1 active
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
10

Cambrex Charles City

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

Holds one active US DMF for diclofenac, filing since 2012. 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
11

Hetero

India
Makes the API

Registered with SFDA (Saudi Arabia) for diclofenac. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
13

COSMA

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

Holds 2 active US DMFs for diclofenac, filing since 2014. Its 2022 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

AMSA

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

Holds one active US DMF for diclofenac, filing since 2000. Its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Arch Pharmalabs

India
Makes the API

Registered with SFDA (Saudi Arabia) for diclofenac. 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 Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Registered with DAV (Vietnam) for diclofenac. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Registered with DAV (Vietnam) for diclofenac. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18

CTCP Dược Đồng Nai

Vietnam
Makes the API

Registered with DAV (Vietnam) for diclofenac.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

Kairav Chemicals

India
Makes the API

Registered with SFDA (Saudi Arabia) for diclofenac.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
20

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for diclofenac. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

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.

Map diclofenac 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.

Export price by year

Year Median Exporters
2026 YTD $35.51 9
2025 $20.00 57
2024 $21.87 74
2023 $25.21 65

US dollars per kilogram, customs export unit values.