Ciprofloxacin, Indian WHO-GMP supply of the broad-spectrum fluoroquinolone with Gram-negative and Pseudomonas cover.

Film-coated tablets in 250, 500 and 750 mg, and ready-to-use intravenous infusion as 200 mg/100 ml and 400 mg/200 ml (2 mg/ml). The 500 mg tablet twice daily is the common adult oral dose; the 750 mg supports high-dose indications such as bone and joint infection and Pseudomonas; the IV bags cover the inpatient phase before the early switch to oral. Tablets ship in Alu-Alu or PVC/PVdC blisters and HDPE bottles (100-tablet tender cartons typical, 500 or 1000-tablet bulk bottles for public-sector supply). Oral suspension and the otic and ophthalmic presentations are separate SKUs and quoted separately. All from Indian WHO-GMP-certified facilities.

No. M Care is a merchant exporter. We supply ciprofloxacin from Indian WHO-GMP-certified manufacturers, including WHO-Prequalified lines 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.

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 (seizures, confusion, psychosis), aortic aneurysm and dissection, exacerbation of myasthenia gravis, and dysglycaemia, alongside QT prolongation, phototoxicity and Clostridioides difficile colitis. The reserve-use advisory is to avoid ciprofloxacin in uncomplicated urinary tract infection, acute sinusitis and acute bronchitis where another antibiotic is available, and to keep it for infections where its Gram-negative and Pseudomonas activity is genuinely needed. We supply the class-safety and antimicrobial-stewardship annex with the consignment so the receiving pharmacy and stewardship team have the framework alongside the product.

Two mechanisms dominate. First, chelation: ciprofloxacin absorption is markedly reduced by divalent and trivalent cations, so antacids, calcium, iron, zinc and magnesium supplements, sucralfate and dairy must be separated from the oral dose, taken either 2 hours before or 6 hours after, or the antibiotic fails silently. Second, CYP1A2 inhibition: ciprofloxacin raises theophylline to toxic levels (monitor or avoid), is contraindicated with tizanidine, and raises caffeine and clozapine. It also potentiates warfarin, so the INR climbs, and adds to the QT effect of other QT-prolonging drugs. NSAID co-administration may lower the seizure threshold. The full interaction reference ships with the consignment for the receiving pharmacy.

Ciprofloxacin is a broad-spectrum fluoroquinolone whose strength is aerobic Gram-negative cover, including Pseudomonas aeruginosa, Enterobacterales and Haemophilus, with useful activity against atypical organisms but unreliable activity against Streptococcus pneumoniae, so it is not a first choice for community-acquired pneumonia. Its established uses are complicated and uncomplicated urinary tract infection and pyelonephritis, intra-abdominal infection in combination with metronidazole for the anaerobic cover, enteric infections such as typhoid fever and shigellosis, bone and joint infection, complicated skin and soft-tissue infection, Pseudomonas infections including respiratory exacerbations in bronchiectasis and cystic fibrosis, and inhalational anthrax. Its high oral bioavailability of around 70 percent supports an early switch from the intravenous to the oral route, a frequent driver of earlier hospital discharge. An antimicrobial-stewardship medicine throughout.

Because ciprofloxacin is long off-patent, the lawful lanes are unrestricted by patent and the molecule is a tender workhorse. 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, tender, hospital and NGO supply against Global Fund, UNICEF Supply Division and ministry procurements), 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 ciprofloxacin 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 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 and CYP1A2 interaction 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.