Levofloxacin, Indian WHO-GMP supply of the respiratory fluoroquinolone for pneumonia, drug-resistant TB and more.
Levofloxacin is the L-isomer of ofloxacin. The FDA label lists it for community-acquired and nosocomial pneumonia, sinusitis, bronchitis exacerbations, skin, urinary and prostate infections, and post-exposure anthrax and plague, one dose every 24 hours. Next to ciprofloxacin, its distinct place is tuberculosis: the WHO Essential Medicines List 2023 carries it among medicines for multidrug-resistant TB, and WHO's 2022 TB guidelines place it in Group A. Quoted as 250, 500 and 750 mg tablets and as infusion. M Care Exports is an Indian merchant exporter and does not manufacture.
Also marketed as Quinsair.
Levofloxacin exporter and bulk supplier from India.
M Care Exports quotes bulk levofloxacin to importers, distributors and tender buyers in any country that licenses the import, with the GCC, Africa and Europe as priority markets. The partner manufacturer's line, strength and pack are written on every quote.
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 are confirmed in the written quote; pre-alert documents go out before dispatch.
250, 500 and 750 mg tablets and infusion · on the WHO EML 2023 MDR-TB list · AWaRe Watch · exporter, not manufacturer.
Active ingredient
Levofloxacin is the L-isomer of the racemate ofloxacin and acts on bacterial topoisomerase IV and DNA gyrase (FDA label, section 12.4). ATC J01MA12; WHO AWaRe 2023 group: Watch. Made by partner manufacturers; M Care does not manufacture.
Strengths stocked
Film-coated tablets of 250, 500 and 750 mg (the three strengths on the FDA label and the WHO EML 2023 MDR-TB entry, which adds a 100 mg dispersible tablet for children) and infusion at 5 mg/ml (the FDA premix label lists 250 mg/50 mL, 500 mg/100 mL and 750 mg/150 mL). One dose every 24 hours: label Table 1 gives 750 mg for 5 days in one pneumonia regimen, 500 mg for 7 to 14 days in the other, and 250 mg for 3 days in uncomplicated UTI.
Indications
Community-acquired pneumonia (two regimens), nosocomial pneumonia, acute bacterial sinusitis, bronchitis exacerbation, skin infections, chronic bacterial prostatitis, complicated and uncomplicated UTI, pyelonephritis, and post-exposure inhalational anthrax and plague (FDA label, section 1). In TB, WHO guidance uses it for MDR/RR-TB and for rifampicin-susceptible, isoniazid-resistant TB.
Safety signals
FDA boxed warning: disabling, potentially irreversible reactions (tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together, and worsening of myasthenia gravis. Label section 5.13: symptomatic hypo- and hyperglycaemia, mostly in diabetics on insulin or an oral agent, with coma and death reported. Section 5.11: avoid with known QT prolongation, uncorrected hypokalaemia or class IA and III antiarrhythmics. Dose adjustment below creatinine clearance 50 mL/min.
Storage and pack
Labelled storage differs by product, so the quote states it for the line offered. The FDA tablet label says 20 to 25°C in well-closed containers; the UK SmPC for a 500 mg tablet says do not store above 25°C in the original package, 4-year shelf life, PVC/aluminium blister; the FDA premix label says at or below 25°C, protect from light and freezing, in a PVC-free flexible container. No cold chain.
Patent & lawful supply
DailyMed, the US National Library of Medicine label index, lists levofloxacin tablet and injection labels from many labellers. Patent status is checked per destination when we quote. We do not supply into India.
Hospital, respiratory, tender and TB-programme channels across the regulated and semi-regulated lanes.
India is our origin. We do not sell into the Indian market. Levofloxacin is exported only.
Sub-Saharan African tender and TB programmes
NAFDAC Nigeria, KEMSA and PPB Kenya and SAHPRA South Africa each have a market page with the route for that country. Levofloxacin is listed in section 6.2.5 of the WHO EML 2023 (antituberculosis medicines, Complementary list for MDR-TB). Where a bid asks for WHO prequalification, the quote says whether the offered line has a WHO reference number.
GCC hospital and ministry supply
Hospital and ministry buying in the Gulf is routed through licensed importers. The registration file (Module 3 and Arabic artwork) follows MoH registration or GCC central registration, whichever the importer's route needs.
UK and the Specials route
The UK SmPC reviewed for this page (emc 12153, levofloxacin 500 mg tablets, PL 28278/0002) covers a 500 mg tablet and contraindicates use under 18 years. A strength or form without a UK licence can go through the named-patient import or MHRA Specials routes.
ASEAN, South Asia and LATAM
Destinations here include the Philippines, Vietnam, Indonesia, Bangladesh, Sri Lanka, Brazil and Mexico, with the registration route agreed per destination. For Indonesia, the WHO prequalified list already holds levofloxacin 500 mg tablets from PT Dankos Farma and PT Sanbe Farma. Germany is served through the import channels.
The respiratory niche, the once-daily IV-to-oral switch, the drug-resistant-TB role, and the class-safety profile.
Levofloxacin's label differs from ciprofloxacin in ways a hospital pharmacy can check. Pneumonia: the FDA label carries community-acquired pneumonia as 750 mg for 5 days or 500 mg for 7 to 14 days (the longer regimen covers multidrug-resistant Streptococcus pneumoniae), nosocomial pneumonia at 750 mg, and names Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae among the organisms. Absorption: absolute bioavailability of the 500 mg and 750 mg tablets is approximately 99%, and tablets can be taken without regard to food. Kidney: the drug is substantially excreted by the kidney, so below creatinine clearance 50 mL/min the dose is adjusted (for the 750 mg regimen, 750 mg every 48 hours at 20 to 49 mL/min). Interactions: give tablets at least two hours before or after magnesium or aluminium antacids, sucralfate, iron or zinc multivitamins; the label found no significant effect on theophylline in healthy volunteers, but the UK SmPC still warns of a lowered seizure threshold with theophylline or NSAIDs; warfarin effect may be enhanced, so INR is monitored. Safety: besides the boxed warning, the label advises blood-glucose monitoring in diabetics, QT caution (section 5.11) and notes severe hepatotoxicity, mostly in the first 14 days (section 5.8). Age: the UK SmPC contraindicates use under 18; the FDA label allows children from 6 months only for post-exposure anthrax and plague. The FDA label restricts use to patients with no alternative in uncomplicated UTI, bronchitis exacerbation and sinusitis. The destination SmPC carries the full text.
The documentation pack a regulator actually asks for.
Partner manufacturers are Indian. M Care holds no WHO-GMP certificate or prequalification of its own; the quote names the producing line, its licence and, if prequalified, its WHO reference number.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.
CTD Module 3
The quality module covers the tablet specification and, for the infusion, sterility and bacterial-endotoxin data. Stability data are submitted for the climatic zone of the destination.
Bioequivalence
A bioequivalence report is supplied for new tablet registrations when the regulator asks for one, with the reference product named.
WHO-PQ and TB-programme
The WHO prequalified list holds levofloxacin tablets under tuberculosis (checked 11 November 2026): film-coated 250 and 500 mg from Micro Labs and Macleods, 250, 500 and 750 mg from MSN Laboratories, 500 mg from PT Dankos Farma and PT Sanbe Farma, 250 mg from Remington Pharmaceutical Industries, and dispersible 100 mg from Macleods and Micro Labs. No infusion is listed. If a tender requires prequalification, the quote gives the WHO reference number of the offered line, or says it has none.
Class-safety + stewardship annex
The destination-language pack insert reproduces the label boxed warning, the two-hour antacid spacing, the renal dose table and the QT caution, so the receiving pharmacy has them with the stock.
CoA + WHO-GMP per batch
Batch CoA against the pharmacopoeial monograph named on the quote, with sterility and bacterial-endotoxin results for the infusion. The CoPP and any WHO-GMP certificate come from the Indian state drug regulator, apostilled if the destination asks.
Pharmacovigilance
A PV contact is named in the destination market where registration needs one. Signals to route under the label: tendon rupture, neuropathy, blood-glucose disturbance, QT prolongation, severe hepatotoxicity (section 5.8) and C. difficile-associated diarrhoea (section 5.10).
Neighbouring antibacterials and the dossier service.
Ciprofloxacin, azithromycin and ceftriaxone, linked below, are also in the WHO AWaRe Watch group (2023).
Ciprofloxacin
A fluoroquinolone in the antibacterial Watch group of the WHO EML 2023 (section 6.2.2). Tablets and IV infusion.
Azithromycin
A macrolide, also in the WHO Watch group (EML 2023, section 6.2.2). Tablet and suspension.
Ceftriaxone
A third-generation cephalosporin, also in the WHO Watch group. IV / IM injection.
NGO and UN procurement
Global Fund, Stop TB Global Drug Facility, UNICEF Supply Division and ministry tender support for TB-programme lines, levofloxacin among them.
CTD / eCTD dossier preparation
CTD Module 3, comparative bioequivalence and the WHO-PQ record assembled for new levofloxacin registrations and tender bids.
Moxifloxacin (Avelox, Vigamox)
Fluoroquinolone · WHO AWaRe Watch · tablets, infusion, eye drops
Fosfomycin
Phosphonic antibiotic · uncomplicated urinary tract infection · WHO AWaRe Watch
Ofloxacin
Fluoroquinolone antibiotic · respiratory, urinary and skin infections · WHO AWaRe Watch
Anti-infectives portfolio →
Every anti-infective line on the site, from antibacterials to antifungals.
Molecule, form, volume, destination: what we need to quote.
- Send us the specifics. Tablet strength (250, 500 or 750 mg) or infusion, monthly volume, destination and buyer type. Say if the tender names WHO prequalification or a pharmacopoeia.
- We name the source line. The producing site, its licence and its WHO reference number if it has one, matched to the destination's requirements.
- Commercial and regulatory offer. Price terms, lead time from the source manufacturer, dossier and bioequivalence status, and the pack insert text.
- Order, release, ship. The source manufacturer releases the batch, then we handle export documents, freight and a pre-alert.
- After delivery. Batch records and CoA are kept for the shelf life of the lot, and the PV contact is opened where registration needs one.
Levofloxacin supply, the specific questions.
What strengths and forms of levofloxacin do you supply?
Film-coated tablets of 250, 500 and 750 mg, and infusion at 5 mg/ml. The FDA label runs one dose every 24 hours: 750 mg for 5 days in one community-acquired pneumonia regimen, 500 mg for 7 to 14 days in the other, 750 mg for 7 to 14 days in nosocomial pneumonia, 500 mg for 28 days in chronic bacterial prostatitis and 250 mg for 3 days in uncomplicated UTI. The UK SmPC for a 500 mg tablet gives 500 mg once daily for 10 to 14 days in acute bacterial sinusitis. Labelled storage differs by product (20 to 25°C on the FDA tablet label, do not store above 25°C on the UK SmPC), so the quote states the storage and pack of the line offered.
Is M Care a levofloxacin manufacturer?
No. M Care Exports is an Indian merchant exporter. Partner manufacturers make and release the product, and M Care handles quotation, export documents and shipping. The quote names the producing line. M Care does not claim WHO-GMP certification or WHO prequalification of its own.
How does levofloxacin differ from ciprofloxacin?
Both are Watch group fluoroquinolones in the WHO AWaRe classification 2023. Their listings differ: the 2023 WHO Essential Medicines List carries levofloxacin in its antituberculosis section for MDR-TB, while ciprofloxacin sits among the Watch group antibacterials. On the FDA label levofloxacin carries community-acquired and nosocomial pneumonia and is dosed once every 24 hours. The choice between them is the prescriber's, and we quote either.
What are the fluoroquinolone class-safety warnings and the reserve-use advisory?
The FDA boxed warning for levofloxacin names disabling and potentially irreversible reactions that can occur together (tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects) and worsening of myasthenia gravis. The label also says to reserve levofloxacin for patients with no alternative in uncomplicated UTI, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis. Tendon risk is higher over 60 years, with corticosteroids and after kidney, heart or lung transplant. The UK SmPC for a 500 mg tablet says the product must only be prescribed when other antibiotics commonly recommended for the infection are inappropriate, for example because of resistance, contraindication, side effects that stopped treatment, or treatment failure. We carry this wording into the destination-language pack insert.
Do you supply levofloxacin for MDR-TB programmes?
Yes. WHO's 2022 Module 4 update puts levofloxacin or moxifloxacin in Group A for longer MDR/RR-TB regimens (a strong recommendation to include one of them) and names levofloxacin or moxifloxacin in the 9-month all-oral regimen. The 6-month BPaLM regimen uses moxifloxacin, and WHO says levofloxacin cannot be recommended as its replacement. For rifampicin-susceptible, isoniazid-resistant TB, WHO suggests rifampicin, ethambutol, pyrazinamide and levofloxacin for 6 months. These are the 2022 recommendations, so check the current WHO edition for the regimen in force. The WHO prequalified list holds levofloxacin tablets from Micro Labs, Macleods and MSN Laboratories among others; if a bid requires prequalification, the quote gives the WHO reference number of the offered line or says it has none. We do not supply into India.
Which markets can you ship levofloxacin into?
Any country that licenses the import. The GCC, Africa and Europe are priority markets, but supply is not limited to them. The registration route, importer licence and artwork are agreed per destination, see the markets pages. We do not supply into India.
What documentation ships with a levofloxacin consignment?
Batch Certificate of Analysis and method of analysis, a bioequivalence report for new tablet registrations, the Certificate of Pharmaceutical Product from the Indian state drug regulator, the source line's WHO-GMP certificate and WHO reference number where it has one, manufacturing licence, Certificate of Origin, and a destination-language pack insert reproducing the label boxed warning, the antacid spacing, the renal dose table and the QT caution. A CTD Module 3 dossier is available, see dossier preparation. Lead time follows the source manufacturer's batch schedule and is given on the quote.
Who stands behind this page.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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 and we will quote.
Strength or infusion, monthly volume, destination, buyer type, and whether the tender names WHO prequalification. We reply with the source line, documents and terms.