Fasigyn (tinidazole), sold in the US as Tindamax, is a single-dose nitroimidazole for trichomoniasis, giardiasis, intestinal amoebiasis and bacterial vaginosis, and FDA-approved generic tinidazole tablets now stand alongside the originator brand in most regulated markets.
M Care Exports supplies Fasigyn (tinidazole), originated by Pfizer and marketed in the United States as Tindamax, a nitroimidazole antiprotozoal and antibacterial dosed as a single high-strength course rather than the multi-day regimen typical of its class-mate metronidazole. M Care is a merchant exporter: we source the originator brand where it still holds a marketing authorisation, and FDA-approved generic tinidazole tablets, through licensed Indian distribution and manufacturing channels, and dispatch on quote, not from our own manufacturing.
Tinidazole exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and tender-desk orders, M Care quotes tinidazole tablets against buyer specification: brand (Fasigyn) where a current local licence exists, or generic, strength mix (250 mg, 500 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because Fasigyn's market presence has thinned in several regulated markets including the UK, we confirm at enquiry stage whether the buyer needs a named-patient or Specials import route or a locally registered generic, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
5-nitroimidazole antiprotozoal and antibacterial, sourced and documented for export.
Tinidazole is a second-generation 5-nitroimidazole that is reduced inside anaerobic bacteria and protozoa to reactive intermediates that damage microbial DNA, giving it activity against Trichomonas vaginalis, Giardia duodenalis and Entamoeba histolytica as well as anaerobic bacteria implicated in bacterial vaginosis. Its defining clinical advantage over metronidazole is dosing convenience: the FDA label treats trichomoniasis and giardiasis with a single 2 g oral dose taken with food, rather than a five-to-seven-day course. Bacterial vaginosis is dosed as 2 g once daily for two days or 1 g once daily for five days, and intestinal amoebiasis or amoebic liver abscess as 2 g daily for three to five days, all in non-pregnant adults. Tindamax/Fasigyn tablets are supplied as 250 mg and 500 mg film-coated tablets; paediatric giardiasis and amoebiasis dosing in patients aged three and over is weight-based at 50 mg/kg, capped at 2 g.
Active ingredient
Tinidazole. 5-nitroimidazole antiprotozoal and antibacterial.
Forms and strengths
250 mg film-coated tablet; 500 mg film-coated tablet.
Indications
Tinidazole, a second-generation nitroimidazole indicated for trichomoniasis, giardiasis, intestinal amoebiasis and amoebic liver abscess, and bacterial vaginosis, dosed as a single or short high-strength course rather than a multi-day regimen. Supplied as originator Fasigyn/Tindamax and FDA-approved generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Film-coated 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.
Buyers for tinidazole are hospital and genitourinary medicine clinic pharmacists treating trichomoniasis and bacterial vaginosis, travel-medicine and gastroenterology services managing giardiasis and amoebiasis, NGO and outbreak-response procurement teams sourcing single-dose antiparasitic treatment for community distribution, national and regional MoH tender desks running antiparasitic and reproductive-health formulary lists, and licensed pharmaceutical wholesalers and importers rebuilding stock where Fasigyn's own market presence has thinned.
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 tinidazole.
Tinidazole's whole clinical value on a formulary is the single-dose course: 2 g once, with food, clears trichomoniasis and adult giardiasis without the multi-day adherence risk metronidazole carries, and the tablet needs no reconstitution, refrigeration or light-protected infusion set, only controlled room-temperature storage between 20 to 25 degrees Celsius, out of light. Two counselling points matter at dispensing: the boxed warning flags carcinogenicity seen in rodents given metronidazole, a structurally related nitroimidazole, so prescribers are directed to reserve tinidazole for its approved indications rather than off-label or repeated courses, and it is contraindicated in patients with Cockayne syndrome because of a documented risk of severe, sometimes fatal, hepatotoxicity in that population. First-trimester pregnancy is contraindicated on the US label, and interruption of breastfeeding is advised during therapy and for three days after the last dose. None of this changes the logistics: it is an ambient-stored oral tablet, not a cold-chain product.
The documentation pack a regulator actually asks for.
Tinidazole tablets travel on standard ambient-temperature logistics, not the cold-chain lanes M Care validates for biologics and insulins; what buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires local registration, CTD or eCTD-format dossier support. On brand versus generic, the picture has shifted: Fasigyn no longer returns an active SmPC or PIL on the UK's electronic Medicines Compendium, so UK buyers should plan on a named-patient or Specials import route or a licensed generic rather than assuming Fasigyn is stocked off-the-shelf. In the US, Tindamax remains FDA-listed alongside multiple FDA-approved generic tinidazole tablet manufacturers, giving buyers a genuine brand-or-generic choice there. Tinidazole is not on the WHO Model List of Essential Medicines; WHO's eEML documentation tracks it within the AWaRe antimicrobial stewardship framework, used to monitor antibiotic access and resistance globally, rather than listing it as a core essential medicine. It is not a controlled substance in the markets M Care serves. M Care does not manufacture tinidazole and does not hold WHO-GMP or WHO-PQ certification in its own name; sourcing is confirmed against the manufacturing partner's current WHO-GMP or EU-GMP status per shipment.
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.
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.
Adjacent lines procurement desks order alongside tinidazole.
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 tinidazole.
- 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.
Tinidazole supply, the specific questions.
Is Fasigyn still available, or has it been replaced by generics?
Fasigyn's market presence has thinned in several regulated markets. In the UK it no longer returns a current product licence on the electronic Medicines Compendium, so supply there runs through a named-patient or Specials import route or a licensed generic. In the US, Tindamax remains FDA-listed alongside FDA-approved generic tinidazole tablets from multiple manufacturers, so a genuine brand-or-generic choice still exists there. M Care checks current local status before quoting either option.
What strengths and pack formats does M Care supply?
250 mg and 500 mg film-coated tablets, matching the Tindamax/Fasigyn strengths. Tell us your indication (trichomoniasis, giardiasis, amoebiasis or bacterial vaginosis) and target dose and we quote the strength split and pack size against it.
Why would a formulary choose tinidazole over metronidazole?
Dosing convenience. The FDA label treats trichomoniasis and adult giardiasis with a single 2 g dose taken with food, versus the five-to-seven-day courses typical of metronidazole. That single-dose profile is attractive for outbreak-response and directly observed treatment settings where multi-day adherence is hard to guarantee, though metronidazole remains the WHO Essential Medicines List's core nitroimidazole and tinidazole is not itself EML-listed.
Is tinidazole safe in pregnancy or for children?
No, not in the first trimester: the US label contraindicates tinidazole in the first trimester of pregnancy, and interruption of breastfeeding is advised during therapy and for three days after the last dose. Tinidazole is licensed for giardiasis and intestinal amoebiasis in children aged three and over at a weight-based dose of 50 mg per kg, capped at 2 g, but is not indicated for trichomoniasis or bacterial vaginosis in that age group.
Does tinidazole carry a boxed warning?
Yes. The FDA label carries a boxed warning for carcinogenicity, based on findings in rodents given metronidazole, a structurally related nitroimidazole; such carcinogenicity data have not been reported for tinidazole itself, but prescribers are directed to reserve it for its approved indications rather than off-label or repeated courses because the two drugs are structurally related and share similar biologic effects. It is also contraindicated in patients with Cockayne syndrome because of a documented risk of severe, sometimes fatal, hepatotoxicity in that population.
What documentation does M Care provide with a tinidazole shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, CTD/eCTD-aligned dossier support where the destination regulator requires local registration, and confirmation of the sourcing partner's current WHO-GMP or EU-GMP status for that batch. We do not claim WHO-GMP or WHO-PQ certification for M Care itself; those credentials sit with the manufacturing partner.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
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.