Molecules / Ofloxacin

Ofloxacin API manufacturers

CAS 82419-36-1 ATC J01MA01 · Fluoroquinolones Updated 9 July 2026
17
manufacturers with an active filing 6 of them hold a US DMF or a CEP
$32.44
median export price per kg $27.65 to $62.35 · 30 exporters · 2025
301
shortage records on file across 15 countries
720
finished-dose makers across 48 regulators
Showing 17 of 17 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Quimica Sintetica

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

Holds one active US DMF for ofloxacin, filing since 2000. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Neuland Laboratories

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

Holds 2 active US DMFs for ofloxacin, filing since 2001. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for ofloxacin, filing since 2023. Its 2023 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
04

Cambrex Charles City

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

Holds one active US DMF for ofloxacin, filing since 2000. 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
05

Mahima Life Sciences

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

Holds one active US DMF for ofloxacin, filing since 2013.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Imexpharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ofloxacin. 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
08

Công ty cổ phần dược phẩm Boston Việt Nam

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ofloxacin. 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
09

Registered with PMDA (Japan) for ofloxacin.

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
10

Cty Tnhh Dược Phẩm Usa-Nic

Vietnam
Makes the API

Registered with DAV (Vietnam) for ofloxacin.

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

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ofloxacin. 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

Công Ty TNHH Dược Phẩm Hạnh Thái

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ofloxacin. 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
14

Registered with DAV (Vietnam) for ofloxacin. 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
15

Registered with DAV (Vietnam) for ofloxacin. 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
16

Công ty TNHH Mekophar

Vietnam
Makes the API

Registered with DAV (Vietnam) for ofloxacin.

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
17

Công ty: CP US Pharma USA

Vietnam
Makes the API

Registered with DAV (Vietnam) for ofloxacin.

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

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 ofloxacin 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.

By country

Export price by year

Year Median Exporters
2025 $32.44 30
2024 $33.39 29
2023 $44.17 22
2022 $41.09 21

US dollars per kilogram, customs export unit values.