Ciprofloxacin, Indian WHO-GMP supply of the broad-spectrum fluoroquinolone with Gram-negative and Pseudomonas cover.
A Watch-group fluoroquinolone on the WHO Model List of Essential Medicines (2023), where it is named first choice for acute invasive bacterial diarrhoea or dysentery, enteric fever and mild to moderate pyelonephritis or prostatitis. M Care Exports offers it as 250, 500 and 750 mg film-coated tablets and as 200 mg/100 ml and 400 mg/200 ml infusion bags, the generic equivalent of Cipro, from Indian partner manufacturers. M Care is an exporter, not a manufacturer.
Also marketed as Ciloxan and Cetraxal.
Ciprofloxacin exporter and bulk supplier from India.
Bulk ciprofloxacin for importers, distributors and tender buyers, quoted by dosage form, strength and pack. M Care is not the manufacturer: each quote names the Indian source line the order is placed with.
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 on the quote; pre-alert documents are sent before dispatch.
Watch-group fluoroquinolone · WHO Model List 2023 · tablets and 2 mg/ml infusion · generic equivalent of Cipro · exporter, not manufacturer.
Active ingredient
Ciprofloxacin, a fluoroquinolone antibacterial. The UK SmPC lists lower respiratory tract and skin and soft-tissue infections due to Gram-negative bacteria, together with urinary tract, intra-abdominal, and bone and joint infections, and advises against it in streptococcal infections including Streptococcus pneumoniae because of inadequate efficacy. Supplied from Indian partner plants; M Care does not manufacture.
Strengths stocked
Film-coated tablets 250, 500 and 750 mg; infusion bags 200 mg/100 ml and 400 mg/200 ml (2 mg/ml, the strength on the WHO Model List). Adult oral doses in the FDA label run from 250 mg every 12 hours for 3 days in acute uncomplicated cystitis to 500 to 750 mg every 12 hours for 4 to 8 weeks in bone and joint infection. The infusion label gives 200 to 400 mg every 8 to 12 hours for urinary infection and 400 mg for most other indications, each infused over 60 minutes.
Indications
The FDA label lists skin and skin structure, bone and joint, complicated intra-abdominal (with metronidazole), infectious diarrhoea, typhoid fever, gonorrhoea, post-exposure inhalational anthrax, plague, chronic bacterial prostatitis, lower respiratory tract, urinary tract infections and acute sinusitis. The UK SmPC adds broncho-pulmonary infection in cystic fibrosis or bronchiectasis.
Safety signals
FDA boxed warning: tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects and exacerbation of myasthenia gravis. Tizanidine is contraindicated and theophylline is marked avoid. Antacids, sucralfate and other multivalent cation products reduce absorption: the FDA label says take ciprofloxacin at least 2 hours before or 6 hours after them.
Storage and pack
Tablets: 20 to 25°C in a well-closed container in the FDA label; the UK SmPC states no special storage conditions. Infusion bags: 5 to 25°C, protect from light, avoid excessive heat, protect from freezing (FDA infusion label). No cold chain. Pack type and remaining shelf life are agreed per order and shown on the proforma.
Patent & lawful supply
No patent restricts supply of ciprofloxacin. The WHO prequalification list carries two ciprofloxacin tablet entries from one Indian applicant: 250 mg (HA716, listed 18 December 2018) and 500 mg (HA738, listed 11 June 2019), both under the HIV/AIDS therapeutic area. They are third-party listings; M Care does not hold prequalification. We do not supply into India.
Where ciprofloxacin goes: hospital pharmacies, ministry stores and programme buyers.
Export only: M Care does not sell ciprofloxacin into India.
Sub-Saharan African tender and NGO supply
Nigeria (NAFDAC), Kenya (KEMSA and PPB), South Africa (SAHPRA), Ghana, Ethiopia, Tanzania and Uganda national regulators. Each quote names the strength and pack so the importer can match it to the product registered with its regulator. Where a bid asks for WHO prequalification, the HA716 and HA738 entries above are the reference points.
GCC hospital and ministry supply
Gulf ministries and hospital groups buy through licensed importers. Our support files are described under MoH registration and GCC central registration, with bilingual Arabic artwork prepared for the destination.
UK and the Specials route
UK supply is by wholesaler or hospital, or through the named-patient import and MHRA Specials routes when an unlicensed product is needed for one patient. The UK SmPC opens by limiting ciprofloxacin to cases where other commonly recommended antibacterials are inappropriate, because of the risk of prolonged, disabling and potentially irreversible reactions, so expect the receiving pharmacy to ask for that framing.
ASEAN, South Asia and LATAM
Brazil (ANVISA) and Mexico (COFEPRIS) in Latin America; Bangladesh (DGDA), Sri Lanka (NMRA), the Philippines (FDA), Vietnam (DAV) and Indonesia (BPOM) in Asia; Germany by import channel. Always through licensed importers, with registration support scoped per destination on the quote.
What the WHO list and the product labels say about ciprofloxacin.
Ciprofloxacin sits in the Watch group of the AWaRe classification on the 2023 WHO Model List. The list names it first choice for acute invasive bacterial diarrhoea or dysentery, enteric fever, low-risk febrile neutropenia and mild to moderate pyelonephritis or prostatitis, and second choice for cholera and mild to moderate complicated intra-abdominal infection; it also lists a 100 mg solid oral form and a 250 mg/5 ml oral liquid for children. The FDA label says it is not a drug of first choice for pneumonia secondary to Streptococcus pneumoniae, and the UK SmPC advises against it in streptococcal infections because of inadequate efficacy; the levofloxacin page covers the neighbouring fluoroquinolone. Absolute oral bioavailability is approximately 70 percent in the FDA label and 70 to 80 percent in the UK SmPC. The FDA boxed warning covers tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects and exacerbation of myasthenia gravis, and says to avoid ciprofloxacin in patients with a known history of myasthenia gravis; it reserves the drug for patients with no alternative treatment option in acute exacerbation of chronic bronchitis, acute uncomplicated cystitis and acute sinusitis. The warnings section also covers aortic aneurysm and dissection, QT prolongation, photosensitivity, Clostridium difficile-associated diarrhoea and blood glucose disturbances, including severe hypoglycaemia resulting in coma or death. Tizanidine is contraindicated; the FDA interaction table marks theophylline, duloxetine, zolpidem and other QT-prolonging drugs as avoid, and warfarin, clozapine, methotrexate, phenytoin, ciclosporin and NSAIDs as use with caution. For antacids, sucralfate and other multivalent cation products the FDA label says 2 hours before or 6 hours after, while the UK SmPC says 1 to 2 hours before or at least 4 hours after. In children the FDA label indicates ciprofloxacin only for complicated urinary tract infection and pyelonephritis (1 to 17 years), post-exposure inhalational anthrax and plague, and states it is not a drug of first choice in the paediatric population. The receiving pharmacy should work from the product information of the registered product it holds.
Documents that travel with a ciprofloxacin order.
Ciprofloxacin comes from Indian partner plants that hold WHO-GMP certification; the certificate and the CoPP of the source line are provided with the quote. Where a tender names WHO prequalification, the exact product and site are checked against the WHO list before a bid is made.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.
CTD Module 3
The quality section is built separately for the film-coated tablet and for the infusion bag, because the two dosage forms carry different specifications. Stability data are matched to the climatic zone of the destination.
Bioequivalence
For tablet registrations the bioequivalence requirement is set by each destination regulator, so it is confirmed per country on the quote rather than assumed.
WHO-PQ where specified
Prequalification attaches to a named product and site. The WHO list shows ciprofloxacin film-coated tablets 250 mg (HA716) and 500 mg (HA738), made at a finished-product site in Gujarat with active ingredient from Telangana. A bid that asks for prequalification is checked against these entries; where the tender accepts a WHO-GMP manufacturer without prequalification, the dossier is supplied for that line instead.
Label safety extract
A short extract of the boxed warning and the interaction table, taken from the product information of the registered product and given in the destination language. It follows the label of the product on your order and does not replace it.
CoA + WHO-GMP per batch
Each batch ships with its Certificate of Analysis against the specification of the registered product, covering the tests that dosage form requires. The CoPP comes from the Indian state drug regulator and is apostilled where the destination asks.
Pharmacovigilance
A named pharmacovigilance contact is set up in the destination market once registration is in place. Adverse-reaction routing follows the boxed-warning reactions: tendon, neuropathy, central nervous system and myasthenia gravis reports, plus aortic events and severe hypoglycaemia.
Pairings and neighbours of ciprofloxacin on the shelf.
The FDA label gives ciprofloxacin with metronidazole for complicated intra-abdominal infection. The other cards are neighbouring antibacterial pages and the dossier services.
Metronidazole
The nitroimidazole anaerobe agent paired with ciprofloxacin for intra-abdominal and gynaecological cover. IV infusion and 200 / 400 mg tablets.
Azithromycin
The macrolide for atypical and community respiratory cover, a different spectrum to ciprofloxacin's Gram-negative niche. Tablet and suspension.
Ceftriaxone
The third-generation cephalosporin workhorse for empirical Gram-negative and respiratory cover. IV / IM injection.
CTD / eCTD dossier preparation
CTD Module 3, comparative bioequivalence and the WHO-PQ record assembled for new ciprofloxacin registrations and tender bids.
NGO and UN procurement
UN and NGO procurement support for essential-medicine lines such as ciprofloxacin, which is on the 2023 WHO Model List.
Moxifloxacin (Avelox, Vigamox)
Fluoroquinolone · WHO AWaRe Watch · tablets, infusion, eye drops
Anti-infectives portfolio →
Every antibacterial, antiviral and antifungal page in one hub.
Four details to start a ciprofloxacin quote.
- Tell us what is needed. Tablet strength (250, 500 or 750 mg) or infusion bag (200 mg/100 ml or 400 mg/200 ml), annual volume, destination, and whether the buyer is a hospital, a ministry store, a tender or a programme. Say if the tender asks for WHO prequalification.
- We match a source line. The line is chosen against the destination's requirements and named on the quote; where a tender names prequalification, the HA716 and HA738 listings are checked first.
- Quote and document list. Price on the Incoterm you choose, lead time, dossier and bioequivalence status, and the document list for your regulator.
- Order and shipment. After release by the source manufacturer's QC, tablets and infusion bags are shipped to the storage condition on their label (see Storage and pack above). Lead time is quoted per order and per dosage form.
- After delivery. Batch records and the CoA stay on file for follow-up queries, and the pharmacovigilance contact handles adverse-reaction reports.
Ciprofloxacin supply, the specific questions.
What strengths and forms of ciprofloxacin do you supply?
Film-coated tablets in 250, 500 and 750 mg, and ready-to-use infusion bags of 200 mg/100 ml and 400 mg/200 ml, which is the 2 mg/ml strength on the WHO Model List. The WHO list also names a 100 mg solid oral form and a 250 mg/5 ml oral liquid for children; oral liquids and the otic and ophthalmic presentations are separate products and are quoted separately. In the FDA label adult tablet doses run from 250 to 750 mg depending on the infection, usually every 12 hours, and the infusion is given over 60 minutes. Pack type is stated on each quote.
Is M Care a ciprofloxacin manufacturer?
No. M Care is a merchant exporter and does not run a manufacturing plant. Ciprofloxacin is bought from Indian partner manufacturers that hold WHO-GMP certification, the source line is named on every quote, and M Care handles export documents, registration support, freight and the pharmacovigilance contact. M Care does not hold WHO prequalification itself; where a tender requires it, the product and site on the WHO list are checked against the line offered.
What are the fluoroquinolone class-safety warnings and the reserve-use advisory?
The FDA boxed warning for ciprofloxacin covers tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects and exacerbation of myasthenia gravis, and says to avoid the drug in patients with a known history of myasthenia gravis. It tells prescribers to reserve ciprofloxacin for patients with no alternative treatment option in acute exacerbation of chronic bronchitis, acute uncomplicated cystitis and acute sinusitis. The label warnings also include aortic aneurysm and dissection, QT prolongation, photosensitivity, Clostridium difficile-associated diarrhoea and blood glucose disturbances. The UK SmPC opens its indications with a restriction because of the risk of prolonged, disabling and potentially irreversible reactions. A short label extract in the destination language can accompany the consignment.
Which drug interactions should we flag for the receiving pharmacy?
Tizanidine is contraindicated with ciprofloxacin in both the FDA label and the UK SmPC. The FDA interaction table marks theophylline, duloxetine, zolpidem and other QT-prolonging medicines as avoid, and warfarin, clozapine, methotrexate, phenytoin, ciclosporin and NSAIDs as use with caution. Antacids, sucralfate, multivitamins and other products containing multivalent cations such as calcium, iron, zinc or magnesium reduce absorption: the FDA label says take ciprofloxacin at least 2 hours before or 6 hours after them, while the UK SmPC says 1 to 2 hours before or at least 4 hours after, so the receiving pharmacy should follow the leaflet of the product it holds.
What is ciprofloxacin used for clinically?
The FDA label lists skin and skin structure infections, bone and joint infections, complicated intra-abdominal infections (with metronidazole), infectious diarrhoea, typhoid fever, uncomplicated gonorrhoea, post-exposure inhalational anthrax, plague, chronic bacterial prostatitis, lower respiratory tract infections, urinary tract infections and acute sinusitis. The UK SmPC adds broncho-pulmonary infections in cystic fibrosis or bronchiectasis. The WHO Model List (2023) places it in the Watch group and names first-choice use in acute invasive bacterial diarrhoea or dysentery, enteric fever, low-risk febrile neutropenia and mild to moderate pyelonephritis or prostatitis. The FDA label says it is not a drug of first choice for pneumonia secondary to Streptococcus pneumoniae.
Which markets can you ship ciprofloxacin into?
M Care ships to importers in any country where the product can be lawfully imported, other than India. Priority destinations are the Gulf (Saudi Arabia, the UAE, Kuwait, Oman, Qatar, Bahrain), Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Egypt) and Europe (the UK by wholesaler, hospital supply and MHRA Specials, and Germany by import channel), with Asian and Latin American importers also served. Registration status and the importer licence are checked per destination before a quote. Full list under markets.
What documentation ships with a ciprofloxacin consignment?
A batch Certificate of Analysis and method of analysis against the specification of the registered product, the Certificate of Pharmaceutical Product from the Indian state drug regulator (apostilled where the destination asks), the WHO-GMP certificate of the source line, the manufacturing licence, a Certificate of Origin and a destination-language leaflet that follows the registered product information. WHO prequalification records are included only where the line offered is itself on the WHO list. A CTD Module 3 dossier can be prepared for registration, see dossier preparation. Lead time depends on the dosage form and the source line and is stated 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.
Sources for the medical and regulatory statements above: the FDA label for ciprofloxacin tablets and for ciprofloxacin injection (DailyMed), the UK SmPC, the WHO Model List of Essential Medicines (23rd list, 2023) and the WHO prequalification entries HA716 and HA738.
Send the specifics and we will come back with a quote.
Strength or bag size, volume, destination, channel, and whether the tender asks for WHO prequalification. We reply with the source line, the document list and the price basis.