Molecules / Loteprednol Etabonate

Loteprednol Etabonate API manufacturers

CAS 82034-46-6 ATC S01BA14 Updated 9 July 2026
7
manufacturers with an active filing 5 of them hold a US DMF or a CEP
$7000.00
median export price per kg $3241.76 to $8047.45 · 10 exporters · 2025
59
finished-dose makers across 26 regulators
Showing 7 of 7 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 loteprednol etabonate, filing since 2014. 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

Zach System

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

Holds one active US DMF for loteprednol etabonate, filing since 1994. Its 2021 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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03

Aarti Pharmalabs

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

Holds one active US DMF for loteprednol etabonate, filing since 2012. 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
04

Farmabios

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

Holds 2 active US DMFs for loteprednol etabonate, filing since 2013. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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

Industriale Chimica

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

Holds one active US DMF for loteprednol etabonate, filing since 2010. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 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
06

Crystal Pharma, S.A.U

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for loteprednol etabonate. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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07

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for loteprednol etabonate. 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

4 more manufacturers hold filings for loteprednol etabonate

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

FarmabiosIndustriale ChimicaCrystal Pharma, S.A.UCông ty Cổ phần Dược phẩm CPC1 Hà Nội
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Finished-dose makers (15)

Bausch & Lomb United States Gilead Sciences United States Lupin India Ajanta Pharma India HIKMA ITALIA Italy Padagis Us United States Alcon Laboratories United States Amneal Pharmaceuticals NY United States Sun Pharma Laboratories India Jamjoom Pharmaceuticals Factory Saudi Arabia Laboratorios Poen S.A.U Argentina Centurion India DEVA HOLDİNG A.Ş. (2020/3) (Hammadde) Turkey Jamjoom Pharmaceuticals Saudi Arabia Orchidia Pharmaceutical Industries 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 loteprednol etabonate?

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

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Also on this molecule

Price history 2 yrs Recalls 2 Finished dose 15 Contract mfrs 0

Export price by year

Year Median Exporters
2025 $7000.00 10
2024 $5305.49 8

US dollars per kilogram, customs export unit values.