Molecules / Nepafenac

Nepafenac API manufacturers

CAS 78281-72-8 ATC S01BC10 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
$13000.00
median export price per kg $8500.00 to $13598.94 · 7 exporters · 2025
6
shortage records on file across 3 countries
96
finished-dose makers across 43 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

FDC

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

Holds one active US DMF for nepafenac, filing since 2024. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 16 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
16 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Medichem

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

Holds one active US DMF for nepafenac, filing since 2014. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Carbogen Amcis

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

Holds one active US DMF for nepafenac, filing since 2004. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Siegfried

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

Holds one active US DMF for nepafenac, filing since 2009. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Matrix Pharmacorp

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

Holds 2 active US DMFs for nepafenac, filing since 2016. Its 2025 FDA inspection closed as VAI.

US DMF
2 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

3 more manufacturers hold filings for nepafenac

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

SiegfriedMatrix PharmacorpAlp Pharm Beijing
Chat with Fred, your AI analyst

Finished-dose makers (20)

Ajanta Pharma India Novartis Manufacturing United States Alcon Laboratories, Inc. Usa United States Novartis Switzerland Stallion Laboratories India Akums Drugs & Pharmaceuticals India Aristopharma Bangladesh Novartis Farmacéutica, S. A Spain S.A. Alcon - Couvreur Belgium Alcon Laboratórios Do Brasil Ltda Brazil General Pharmaceuticals Bangladesh Marcyrl Pharmaceutical Industries Egypt Alcon Laboratories United States Appasamy Ocular Devices Pvt.Ltd India Atco Laboratories Pakistan Sunways Rohto Pharmaceutical Private Limited 803,804,805 India Công ty Cổ phần Dược phẩm CPC1 Hà Nội Vietnam Laboratorios L O Oftalmi C A Venezuela Orchidia Pharmaceutical Industries Egypt Rameda Egypt

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.

Who makes nepafenac?

Ask Fred which manufacturers are on record for nepafenac and what filings they hold.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Also on this molecule

Price history 4 yrs Shortages 6 Recalls 1 Finished dose 20 Contract mfrs 0

Export price by year

Year Median Exporters
2025 $13000.00 7
2024 $12323.22 8
2023 $16241.54 7
2022 $18892.49 12

US dollars per kilogram, customs export unit values.