Gemifloxacin never reached the EU market and was discontinued in the US, but it stayed registered and prescribed across parts of the GCC, Africa and Asia, which is where M Care's supply lines for it are built.
M Care Exports supplies gemifloxacin, a once-daily oral fluoroquinolone for acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia, to hospital pharmacies and tender desks in the markets where it still holds registration. Originator Factive was developed by LG Life Sciences and never gained an EU authorisation; we source WHO-GMP generic gemifloxacin mesylate tablets from Indian manufacturing partners against buyer specification, not from our own production.
Gemifloxacin exporter and bulk supplier from India.
Gemifloxacin sits outside the moxifloxacin/levofloxacin mainstream that dominates most Western respiratory formularies, so demand runs through specific registered markets rather than broad multi-country tenders. M Care quotes 320 mg gemifloxacin mesylate tablets against confirmed buyer registration status and purchase order, sourced through WHO-GMP Indian manufacturing partners, with batch-specific certificates of analysis and CDSCO export documentation compiled per shipment. We confirm the destination regulator's current registration position before quoting, since gemifloxacin's market footprint is narrower and more country-specific than older fluoroquinolones.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Fourth-generation fluoroquinolone antibacterial (DNA gyrase / topoisomerase IV inhibitor), sourced and documented for export.
Gemifloxacin is a fourth-generation oral fluoroquinolone. It inhibits bacterial DNA gyrase and topoisomerase IV, giving it activity against the Streptococcus pneumoniae, Haemophilus influenzae and atypical organisms that drive most community-acquired respiratory infections.
The FDA label covers two indications: acute bacterial exacerbation of chronic bronchitis (ABECB) and community-acquired pneumonia (CAP) of mild to moderate severity, caused by susceptible organisms, in patients 18 years and older. It carries the standard fluoroquinolone-class boxed warning on tendinitis, tendon rupture and exacerbation of myasthenia gravis, alongside label warnings on peripheral neuropathy, CNS effects, QT prolongation and Clostridioides difficile-associated diarrhoea.
It is supplied as a single-strength 320 mg film-coated tablet, taken orally once daily, with or without food. There is no injectable or IV presentation and no reconstitution step; it is an ambient-temperature oral solid, not a cold-chain product.
Active ingredient
gemifloxacin mesylate. Fourth-generation fluoroquinolone antibacterial (DNA gyrase / topoisomerase IV inhibitor).
Forms and strengths
320 mg film-coated tablet.
Indications
Oral fluoroquinolone indicated for acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia of mild to moderate severity caused by susceptible organisms, in adults 18 years and older.
Administration
oral. Film-coated tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for gemifloxacin through M Care are hospital pharmacists and MoH tender desks in the specific GCC and African markets where it remains registered, licensed importers who already hold or are pursuing local registration for the molecule, and NGO or programme procurement officers building out a respiratory antibiotic line where gemifloxacin sits on the local formulary. Because registration is narrower than for ciprofloxacin or levofloxacin, we confirm a buyer's country and current authorisation status before quoting, rather than assuming universal availability.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on gemifloxacin.
Gemifloxacin is dosed at 320 mg orally once daily: 5 days for ABECB, 5 to 7 days for CAP depending on clinical judgement. In patients with creatinine clearance at or below 40 mL/min, including those on haemodialysis or CAPD, the dose halves to 160 mg once daily; no adjustment is needed above that threshold. Counsel dispensing staff on the class-typical cation interaction: antacids containing magnesium or aluminium, and iron or zinc supplements, chelate gemifloxacin and cut absorption, so gemifloxacin must not be taken within 3 hours before or 2 hours after these products. Gemifloxacin carries the standard fluoroquinolone boxed warning for tendinitis and tendon rupture, with added caution in patients on concomitant corticosteroids, plus label warnings for peripheral neuropathy, CNS effects (tremor, confusion, hallucination), QT-interval prolongation and Clostridioides difficile-associated diarrhoea. Rash is a distinctive signal for this particular fluoroquinolone: it drove a meaningful share of discontinuations in registration trials and is the reason clinicians are told to stop the drug immediately if a rash develops rather than wait it out. As an oral solid with a single 320 mg strength, there is no reconstitution or cold-chain handling to manage; storage is standard controlled room temperature.
The documentation pack a regulator actually asks for.
Gemifloxacin's regulatory history is unusual for a fluoroquinolone: Menarini withdrew the centralised EU marketing authorisation application for Factive in 2009 after the EMA's scientific committee could not establish a positive benefit-risk balance, largely on rash frequency, so the molecule has no EU authorisation to reference. In the US, Factive was FDA-approved and an ANDA for generic gemifloxacin mesylate 320 mg tablets was approved in 2015, but the FDA's own records now list the branded product as discontinued, explicitly not for safety or effectiveness reasons, and no generic is currently marketed there either. It is not carried on the WHO Essential Medicines List, where ciprofloxacin, levofloxacin and moxifloxacin remain the listed respiratory-relevant fluoroquinolones.
What gemifloxacin does have is a genuine, ongoing footprint outside the US and EU: it remains registered and marketed in a number of GCC, African, Latin American and Asian markets, where local MoH and drug-regulatory authorities have not withdrawn its authorisation the way the EMA did. M Care sources WHO-GMP generic gemifloxacin mesylate tablets from Indian manufacturing partners for buyers in markets where it holds current registration, with CTD/eCTD dossier support, batch-specific certificates of analysis and CDSCO export documentation compiled per shipment. We confirm a destination market's registration status with the buyer before quoting rather than assuming coverage, given how country-specific gemifloxacin's authorisation picture is compared with older-generation fluoroquinolones.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside gemifloxacin.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for gemifloxacin.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Gemifloxacin supply, the specific questions.
Is gemifloxacin available in the UK or EU?
No. The EU marketing authorisation application for Factive (gemifloxacin) was withdrawn by the applicant in 2009 after the EMA's scientific committee could not establish a positive benefit-risk balance, so gemifloxacin has never held an EU authorisation. It is not marketed in the UK either. M Care's gemifloxacin supply lines run to the GCC, African and other markets where it remains registered.
Is gemifloxacin still available in the US?
The originator, Factive, was FDA-approved and a generic ANDA was approved in 2015, but FDA records now list the branded product as discontinued, and not for safety or effectiveness reasons, and no generic is currently marketed there either. Gemifloxacin remains registered and in active use in a number of other markets, including parts of the GCC and Africa, which is where M Care sources and ships it.
Is a generic version of gemifloxacin available?
Yes. M Care sources generic gemifloxacin mesylate 320 mg tablets from WHO-GMP Indian manufacturing partners. The originator brand, Factive (LG Life Sciences), is not part of our supply chain; we quote the generic against confirmed buyer registration and purchase order.
What is gemifloxacin licensed to treat?
The FDA label covers two indications: acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia of mild to moderate severity, both caused by susceptible organisms, in adults 18 years and older. Confirm licensed indications against your own destination-country labelling before finalising a tender specification.
Does gemifloxacin need cold-chain shipping?
No. It is a 320 mg film-coated tablet stored at standard controlled room temperature. There is no injectable presentation, no reconstitution step and no cold-chain requirement, which keeps freight and warehousing straightforward for tender-lot orders.
Can M Care supply gemifloxacin to our market?
Where gemifloxacin holds current local registration, yes. Because its authorisation footprint is narrower and more country-specific than older fluoroquinolones such as ciprofloxacin or levofloxacin, we confirm your market's registration status before quoting rather than assuming coverage; contact the Mumbai desk with your country and licence status.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.