Ofloxacin is the racemic parent of levofloxacin, and WHO's own tuberculosis treatment guidance has already shifted second-line regimens onto that single active enantiomer.
Ofloxacin is the racemic compound that gave rise to levofloxacin, its more active single enantiomer. WHO's programmatic guidance for drug-resistant tuberculosis has largely moved on to levofloxacin, whose active S-enantiomer carries roughly double the in vitro antibacterial activity per milligram of the ofloxacin racemate. That shift narrowed ofloxacin's largest institutional demand channel but did not remove the molecule from clinical use. M Care Exports supplies ofloxacin 100mg, 200mg and 400mg oral tablets, sourced from WHO-GMP certified Indian manufacturers, to regulatory affairs teams and procurement desks across UK/EU, Gulf, Africa, Latin America, Southeast Asia and CIS markets.
Ofloxacin exporter and bulk supplier from India.
M Care exports ofloxacin 100mg, 200mg and 400mg oral tablets in standard pharmaceutical trade packing, typically blister strips inside cartons, sized and labelled to the importing country's requirements. Each shipment carries a batch-specific certificate of analysis tested against the applicable pharmacopoeial monograph, along with the manufacturer's stability data, since fluoroquinolone tablets are formulated for storage below 30 degrees Celsius and protected from the excess humidity common on tropical export lanes to Africa, the Gulf and Southeast Asia. Export documentation includes the CDSCO export NOC, packing list, commercial invoice and certificate of origin, plus a certificate of pharmaceutical product where the destination regulator requires one. M Care coordinates with the sourcing manufacturer on any additional dossier documents a specific import authority requests before shipment.
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.
Fluoroquinolone antibacterial, sourced and documented for export.
Ofloxacin is the racemic parent of levofloxacin: the fluoroquinolone splits into two mirror-image forms, and only the S-enantiomer, levofloxacin, carries most of the antibacterial activity. WHO's guidance for longer MDR-TB regimens has accordingly shifted toward levofloxacin, and WHO's TB technical documentation now states there is little reason for programmes to continue choosing ofloxacin. That leaves ofloxacin's remaining global demand concentrated outside tuberculosis: general second-line treatment of susceptible urinary, respiratory and selected gastrointestinal infections, largely in formularies that have not fully transitioned to levofloxacin. Clinically, ofloxacin carries the same class-wide fluoroquinolone boxed warning as levofloxacin (tendinitis, tendon rupture, peripheral neuropathy, CNS effects) and the same 2019 EU restriction against first-line use for mild or moderate infections. M Care stocks the molecule strictly as oral tablets.
Active ingredient
Ofloxacin. Fluoroquinolone antibacterial.
Forms and strengths
100 mg; 200 mg; 400 mg.
Indications
Ofloxacin is a second-generation fluoroquinolone antibacterial administered as a racemate; its active S-enantiomer is marketed separately as levofloxacin. M Care Exports supplies ofloxacin strictly as oral tablets, sourced from WHO-GMP certified Indian manufacturers.
Administration
Oral. 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.
Ofloxacin tablets move through regulatory affairs teams, hospital and institutional pharmacy procurement, and licensed importers preparing tender submissions across the UK, the EU, Gulf and GCC states, African national and regional buyers, Latin America, Southeast Asia and CIS markets. Because the EU's 2019 fluoroquinolone-wide restriction confines ofloxacin to second-line prescribing, EU buyers are typically formulary teams stocking it as a reserve option rather than a first-line volume line. Gulf and African tender desks more often carry it as a standard general-purpose fluoroquinolone within broader anti-infective lots. Buyers are expected to hold, or be applying for, the import and marketing authorisations their own jurisdiction requires. M Care does not supply into India, which is the country of manufacture, not a served market.
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 ofloxacin.
Ofloxacin is administered as the full racemate: both the S-enantiomer that carries most of the antibacterial activity and the R-enantiomer that contributes comparatively little. A reviewing pharmacist comparing ofloxacin to levofloxacin on a formulary should weigh that a levofloxacin dose delivers similar exposure to active drug from roughly half the total milligram load, part of why levofloxacin has displaced ofloxacin in higher-value programmatic use. On the ofloxacin product itself, checks that matter include renal function, since the drug is cleared substantially unchanged by the kidney and requires dose interval adjustment in renal impairment; concurrent use of QT-prolonging agents, given the fluoroquinolone class effect on cardiac repolarisation; co-administration timing against antacids, iron, zinc or calcium products, which chelate ofloxacin and reduce oral absorption if dosed together; glucose monitoring in patients on sulfonylureas or insulin, since fluoroquinolones can disturb glucose homeostasis in either direction; and a tendon and neurologic history, given the class's boxed warning for tendinopathy and peripheral neuropathy that can persist after the course ends.
The documentation pack a regulator actually asks for.
Ofloxacin tablets ship with a documentation pack built around three anchors: M Care's own ISO 9001:2015 quality management certification, its CDSCO export licence, and batch-specific quality evidence from the sourcing manufacturer, which holds WHO-GMP certification for the facility producing the tablets. Per batch, that evidence includes a certificate of analysis tested against the relevant pharmacopoeial monograph (assay, dissolution, related substances and content uniformity for a fluoroquinolone tablet), a certificate of origin, and stability data supporting the labelled shelf life under the storage conditions specified on the pack. Because ofloxacin's product information has been revised in several jurisdictions to reflect the EU's 2019 fluoroquinolone-wide prescribing restriction and its class boxed warning, buyers reviewing the dossier should expect current, narrowed-indication labelling rather than older, broader-use versions. Where a destination regulator requires a certificate of pharmaceutical product or free-sale certificate, M Care coordinates that request with the sourcing manufacturer ahead of shipment rather than after an order is placed.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
FDA and EU boxed warning: fluoroquinolones including ofloxacin carry risk of tendinitis, tendon rupture, peripheral neuropathy and CNS effects that can be disabling and persist after the course ends
2019 EU Article 31 referral restricts systemic fluoroquinolones, including ofloxacin, to second-line use; not indicated for mild, self-limiting or non-severe bacterial infections
Ofloxacin is a racemic mixture; its single active enantiomer, levofloxacin, is WHO's preferred fluoroquinolone for longer MDR-TB regimens, and WHO documentation states there is little reason for programmes to continue choosing ofloxacin
Caution or avoidance advised in myasthenia gravis due to risk of exacerbation
QT-interval prolongation risk; caution with other QT-prolonging medicines
Chelation with antacids, iron, zinc and calcium products reduces oral absorption if co-administered
Adjacent lines procurement desks order alongside ofloxacin.
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 ofloxacin.
- 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.
Ofloxacin supply, the specific questions.
Why has global demand for ofloxacin shifted toward levofloxacin?
Levofloxacin is the single active S-enantiomer of racemic ofloxacin, carrying roughly double the in vitro antibacterial activity per milligram of the ofloxacin racemate. WHO's technical guidance for longer multidrug-resistant tuberculosis regimens has moved toward levofloxacin accordingly, and WHO's own TB documentation now states there is little reason for programmes to continue choosing ofloxacin. That shift concentrated in tuberculosis procurement, not in ofloxacin's other established uses.
What restrictions apply to ofloxacin's use in the EU?
A 2019 EU-wide referral under Article 31 restricted all systemic fluoroquinolones, including ofloxacin, to second-line use. They should not be prescribed for infections that are mild, self-limiting, or treatable with commonly recommended antibiotics, and carry a boxed warning for tendinitis, tendon rupture, peripheral neuropathy and central nervous system effects. Buyers should expect current, narrowed-indication labelling.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. M Care holds ISO 9001:2015 quality management certification and a CDSCO export licence, and sources ofloxacin tablets from WHO-GMP certified Indian manufacturers, whose facility-level certification and batch documentation accompany each shipment.
What dosage forms and strengths of ofloxacin does M Care supply?
M Care supplies ofloxacin only as oral tablets, in 100mg, 200mg and 400mg strengths, across 30 stocked lines. M Care does not supply ofloxacin capsules, injections, oral suspension, ophthalmic, otic, topical or inhaled forms; those forms exist clinically but sit outside M Care's current catalogue.
Can ofloxacin tablets be supplied for hospital or government tender procurement?
Yes. M Care supports tender and institutional procurement with batch-specific certificates of analysis, stability data, and export documentation including the CDSCO export NOC and certificate of origin. Buyers should confirm in advance whether their tender specification requires ofloxacin specifically or accepts levofloxacin, since many institutional formularies have moved toward the latter.
Which markets does M Care supply ofloxacin to?
M Care supplies licensed importers, hospital and institutional pharmacy buyers and tender desks across the UK, the EU, Gulf and GCC states, Africa, Latin America, Southeast Asia and CIS markets. India is the country of manufacture and is not a served market.
Is ofloxacin still an appropriate first-line choice for uncomplicated infections?
No, not under current EU and US labelling. Fluoroquinolones including ofloxacin are reserved for infections where other commonly recommended antibiotics are unsuitable, following 2016 and 2019 regulatory reviews that found the disabling, potentially irreversible side-effect profile outweighs the benefit in mild or self-limiting infections.
What pharmacopoeial standard does M Care test ofloxacin tablets against?
Each batch carries a certificate of analysis tested against the pharmacopoeial monograph applicable to the shipment (assay, dissolution, related substances, content uniformity), supplied by the sourcing manufacturer. Buyers requiring testing against a specific pharmacopoeia should confirm that requirement before order confirmation.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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. 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.