Levofloxacin, Indian WHO-GMP supply of the respiratory fluoroquinolone for pneumonia, drug-resistant TB and more.

Film-coated tablets in 250, 500 and 750 mg, and ready-to-use intravenous infusion as 500 mg/100 ml and 750 mg/150 ml (5 mg/ml). Levofloxacin is dosed once daily: the 500 mg tablet is the common dose for community-acquired pneumonia, sinusitis and complicated UTI, the 750 mg supports the high-dose short-course regimens, and the 250 mg covers lower-dose and renally adjusted indications. Tablets ship in Alu-Alu or PVC/PVdC blisters and HDPE bottles (100-tablet tender cartons typical, bulk bottles for public-sector and TB-programme supply). The oral solution is a separate SKU. All from Indian WHO-GMP-certified facilities.

No. M Care is a merchant exporter. We supply levofloxacin from Indian WHO-GMP-certified manufacturers, including WHO-Prequalified lines and the formulations used in MDR-TB programmes where a tender requires it, and handle export, documentation, registration support, freight and pharmacovigilance set-up. We do not run a manufacturing plant ourselves. For a buyer that means we route each order to the right WHO-GMP line for the destination, including an EU-GMP-capable line where the destination requires it, and carry the regulatory and logistics paperwork including the fluoroquinolone class-safety and stewardship annexes.

Both are fluoroquinolones, but they occupy different niches. Levofloxacin is a respiratory fluoroquinolone with reliable activity against Streptococcus pneumoniae and the atypical respiratory pathogens (Legionella, Mycoplasma, Chlamydophila), which makes it a genuine option for community-acquired pneumonia and sinusitis where ciprofloxacin is unreliable. Ciprofloxacin is stronger against Pseudomonas aeruginosa and is the better choice for that and for urinary and intra-abdominal Gram-negative infections. Levofloxacin is dosed once daily with near-complete (around 99 percent) oral bioavailability, and unlike ciprofloxacin it does not significantly inhibit CYP1A2, so it lacks the theophylline and tizanidine interaction, though it is renally cleared and needs dose adjustment in renal impairment. Levofloxacin also has a defined role as a WHO Group A agent in drug-resistant tuberculosis regimens. The prescriber selects on the target organism and the clinical setting; we supply either.

Medicines regulators including the FDA and EMA have restricted fluoroquinolone use because of disabling and potentially irreversible adverse reactions. The recognised signals are tendinitis and tendon rupture (most often the Achilles, with higher risk over 60 years, on corticosteroids, or after organ transplant), peripheral neuropathy, central nervous system effects, aortic aneurysm and dissection, exacerbation of myasthenia gravis, and dysglycaemia, to which levofloxacin is particularly prone in older and diabetic patients, alongside QT prolongation (somewhat greater than ciprofloxacin), phototoxicity and Clostridioides difficile colitis. The reserve-use advisory is to avoid levofloxacin in uncomplicated infections where another antibiotic is available and to keep it for community-acquired pneumonia, drug-resistant TB and other settings where its profile is genuinely needed. We supply the class-safety and antimicrobial-stewardship annex with the consignment so the receiving pharmacy and stewardship or TB-programme team have the framework alongside the product.

Yes. Levofloxacin is a WHO Group A fluoroquinolone in the treatment of multidrug-resistant and rifampicin-resistant tuberculosis, used within a combination regimen and often at the higher daily dose, and it is one of the high-volume lines in national TB programmes and Global Fund, Stop TB Partnership Global Drug Facility and ministry procurements across the high-burden markets of sub-Saharan Africa and Asia. We supply from WHO-Prequalified and WHO-GMP lines that carry the programme-acceptable specification, provide the prequalification record with the bid pack, and support the registration and tender documentation. We do not supply into India.

Because levofloxacin is off-patent, the lawful lanes are unrestricted by patent and the molecule is both a respiratory-infection workhorse and a TB-programme line. The UK (wholesaler and hospital supply, and MHRA Specials where an unlicensed import is needed for a named patient), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain through licensed importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Egypt, hospital, tender, NGO and TB-programme supply), ASEAN and South Asia (Philippines FDA, Vietnam DAV, Indonesia BPOM, Bangladesh DGDA, Sri Lanka NMRA) and Germany through the import channels. We do not supply into India. Full list under markets.

Batch-specific Certificate of Analysis (HPLC levofloxacin assay, related substances per Ph.Eur./USP, dissolution profile, content uniformity, water content; sterility, bacterial endotoxin and particulate matter for the IV infusion), Method of Analysis, bioequivalence study report for new tablet registrations, Certificate of Pharmaceutical Product (CoPP) from CDSCO India, WHO-GMP certificate and WHO-PQ record where the tender or TB programme specifies it, manufacturing licence, Certificate of Origin, and a destination-language pack insert carrying the fluoroquinolone class-safety warnings, the reserve-use advisory, the chelation interaction and renal-dose-adjustment notes and the QT caution. CTD Module 3 dossier available against an NDA, see dossier preparation. For registered markets with stock, dispatch is typically 5-10 working days; made-to-order tablet batches run 4-8 weeks and the sterile IV infusion 6-10 weeks. Both forms travel at controlled ambient with no cold-chain surcharge.