Molecules / Gatifloxacin

Gatifloxacin API manufacturers

CAS 112811-59-3 ATC J01MA16 · Fluoroquinolones Updated 9 July 2026
8
manufacturers with an active filing 7 of them hold a US DMF or a CEP
5
shortage records on file across 2 countries
63
finished-dose makers across 23 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Apotex

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

Holds one active US DMF for gatifloxacin, filing since 2007. 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
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03

Lupin

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

Holds one active US DMF for gatifloxacin, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Apitoria Pharma

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

Holds one active US DMF for gatifloxacin, filing since 2012. 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

Matrix Pharmacorp

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

Holds one active US DMF for gatifloxacin, filing since 2003. 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
06

Kyorin Pharmaceutical

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

Holds one active US DMF for gatifloxacin, filing since 2001. Its GMP is recognised in 3 markets.

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

Sthree Chemicals

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

Holds one active US DMF for gatifloxacin, filing since 2024.

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
08

Registered with SFDA (Saudi Arabia) for gatifloxacin. 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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5 more manufacturers hold filings for gatifloxacin

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

Apitoria PharmaMatrix PharmacorpKyorin PharmaceuticalSthree ChemicalsHuanggang Yinhe Aarti Pharmaceutical Co.,Ltd
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Contract manufacturers (4)

Ciron Drugs & Pharmaceuticals India Acme Generics India Galentic Pharma India Yangtze River Pharmaceutical Group China

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

Finished-dose makers (18)

Abbvie United States Allergan Sales United States Caplin Steriles India Cipla India Sandoz Switzerland HIKMA ITALIA Italy Allergan Produtos Farmaceuticos Ltda Brazil Laboratorios Poen S.A.U Argentina Bristol-Myers Squibb United States Jamp Pharma Canada Jamjoom Pharmaceuticals Factory Saudi Arabia Allergan United States Delta Grand Pharma Egypt Grünenthal Germany Rising United States Jamjoom Pharmaceuticals Saudi Arabia Laboratorios Antillanos Edmar, S. A. (LAANED) Dominican Republic 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

Who makes gatifloxacin?

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

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Also on this molecule

Shortages 5 Recalls 6 Finished dose 18 Contract mfrs 4

By country

India 5