Molecules / Fluorometholone

Fluorometholone API manufacturers

CAS 426-13-1 ATC C05AA06 Updated 9 July 2026
5
manufacturers with an active filing 4 of them hold a US DMF or a CEP
15
shortage records on file across 5 countries
152
finished-dose makers across 40 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Curia Spain S.A.U

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

Holds one active US DMF for fluorometholone, filing since 2022. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

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

Henan Lihua Pharmaceutical

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

Holds one active US DMF for fluorometholone, filing since 2023. Its 2021 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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03

Euroapi France

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

Holds 2 active US DMFs for fluorometholone, filing since 1982. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Farmabios

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

Holds one active US DMF for fluorometholone, filing since 2021. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Registered with DAV (Vietnam) for fluorometholone. 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
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2 more manufacturers hold filings for fluorometholone

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

FarmabiosCông ty cổ phần Tập đoàn Merap
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Contract manufacturers (1)

Galentic Pharma India

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

Finished-dose makers (32)

Abbvie United States Allergan Sales United States Sandoz Switzerland Divine Laboratories India Amneal Pharmaceuticals NY United States Cipla India Gilead Sciences United States Micro Labs India Novartis Switzerland Sanofi France Théa PHARMA France Ursapharm Arzneimittel Germany Adcock Ingram South Africa Aristopharma Bangladesh Laboratórios Sophia S.A. De C.V Mexico Indiana Ophthalmics India Laboratório Edol - Produtos Farmacêuticos Portugal Sunways (India) Pvt.Ltd India Samchundang Pharm South Korea Binex Co.,ltd South Korea

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

Who makes fluorometholone?

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

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Also on this molecule

Shortages 15 Finished dose 32 Contract mfrs 1