Molecules / Entacapone

Entacapone API manufacturers

CAS 130929-57-6 ATC N04BX02 Updated 9 July 2026
14
manufacturers with an active filing 11 of them hold a US DMF or a CEP
$161.05
median export price per kg $120.00 to $220.74 · 8 exporters · 2025
53
shortage records on file across 5 countries
223
finished-dose makers across 30 regulators
Showing 14 of 14 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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

Holds one active US DMF and one valid CEP for entacapone, filing since 2012. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
03

Piramal Pharma

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

Holds one active US DMF and one valid CEP for entacapone, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
06

Fermion Oy

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

Holds one active US DMF and one valid CEP for entacapone, filing since 1997. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
07

Hec Pharm

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

Holds one active US DMF and one valid CEP for entacapone, filing since 2013. Its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
4 markets
08

Ipca Laboratories

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

Holds 2 valid CEPs for entacapone, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
How this listing is sourced EDQM certificate database
View profile
09

Apitoria Pharma

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

Holds one active US DMF and one valid CEP for entacapone, filing since 2010. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for entacapone, filing since 2010. 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
11

Suven Pharmaceuticals

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

Holds 4 active US DMFs for entacapone, filing since 2006. Its GMP is recognised in 1 market.

US DMF
4 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
12

Ra Chem Pharma

India
Makes the API

Registered with SFDA (Saudi Arabia) for entacapone. 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
13

Aurobindo Pharma Limited, Unit I

India
Makes the API

Registered with SFDA (Saudi Arabia) for entacapone.

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
14

Registered with SFDA (Saudi Arabia) for entacapone.

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

11 more manufacturers hold filings for entacapone

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 (4)

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

Sold in these combinations

Fixed-dose combinations containing entacapone. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2025 $161.05 8
2024 $201.89 7
2023 $190.00 10
2022 $195.00 7

US dollars per kilogram, customs export unit values.