Molecules / Levofloxacin

Levofloxacin API manufacturers

CAS 100986-85-4 ATC J01MA12 · Fluoroquinolones Updated 9 July 2026
49
manufacturers with an active filing 25 of them hold a US DMF or a CEP
$110.00
median export price per kg $32.65 to $165.00 · 59 exporters · 2025
111
shortage records on file across 11 countries
1,728
finished-dose makers across 53 regulators
Showing 20 of 49 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF and one valid CEP for levofloxacin, filing since 2003. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
02

Macleods Pharmaceuticals

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

Holds one active US DMF and 2 valid CEPs for levofloxacin, filing since 2008. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
03

MSN Life Sciences

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

Holds one active US DMF and one valid CEP for levofloxacin, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
05

Zydus Lifesciences

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

Holds one active US DMF and one valid CEP for levofloxacin, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Neuland Laboratories

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

Holds 2 active US DMFs and one valid CEP for levofloxacin, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
07

Teva

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

Holds one active US DMF for levofloxacin, filing since 2003. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
42 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Apotex

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

Holds one active US DMF for levofloxacin, filing since 2006. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Hetero

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

Holds 2 active US DMFs for levofloxacin, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Cipla

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

Holds 2 active US DMFs for levofloxacin, filing since 2002. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Quimica Sintetica

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

Holds one active US DMF for levofloxacin, filing since 2014. 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
14

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 levofloxacin, filing since 2008. 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
15

Shaoxing Jingxin Pharmaceutical

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

Holds one valid CEP for levofloxacin, filing since 2026. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
16

Itf Chemical Ltda

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

Holds one active US DMF for levofloxacin, filing since 2004. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Orbion Pharmaceuticals

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

Holds one active US DMF for levofloxacin, filing since 2010.

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
18

Zhejiang Starry Pharmaceutical

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

Holds one valid CEP for levofloxacin, filing since 2023. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
19

Hec Pharm

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

Holds one active US DMF for levofloxacin, filing since 2012. Its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Viatris

United States
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for levofloxacin. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
18 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

Contract manufacturers (10)

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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Export price by year

Year Median Exporters
2026 YTD $100.64 12
2025 $110.00 59
2024 $110.00 49
2023 $120.00 39

US dollars per kilogram, customs export unit values.