Metronidazole — Indian supplier of 500mg/100ml IV infusion and 200mg / 400mg tablets to UK, GCC and African tender desks.

A nitroimidazole on the WHO Essential Medicines List core list — anaerobic and protozoal cover in a molecule every hospital formulary and public-sector tender expects. Ready-to-use 500mg/100ml IV infusion bags and 200mg / 400mg film-coated tablets from Indian WHO-GMP partner lines, with the CTD dossier and WHO-PQ pathway documentation on file.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
At a glance

Multiple WHO-GMP partner lines · 500mg/100ml IV, 200mg and 400mg tablets · WHO EML core.

Active ingredient

Metronidazole. Nitroimidazole antibacterial and antiprotozoal — a prodrug reduced inside anaerobes to a cytotoxic nitro-radical anion that breaks DNA strands. Inactive against aerobic organisms, which keeps spectrum tight and collateral damage to commensal flora lower than broad-spectrum alternatives.

Strengths stocked

Three SKUs in scope for this spoke. 500mg/100ml polyolefin infusion bag (5mg/ml), ready-to-use, no reconstitution required. 200mg and 400mg film-coated tablets in PVC/PVdC-Aluminium blisters or HDPE bottles. Topical gel, vaginal gel, suspension and suppository forms are quoted separately.

Indications

Anaerobic infections (Bacteroides, Clostridium), surgical prophylaxis for colorectal, gynaecological and abdominal procedures, intestinal and hepatic amoebiasis, giardiasis, trichomoniasis, bacterial vaginosis, pelvic inflammatory disease, and H. pylori eradication in triple or quadruple therapy. Retained in the WHO EML for C. difficile where vancomycin or fidaxomicin are unavailable.

Storage

IV infusion: 15-25°C, protected from light in the outer wrap. Do not refrigerate — metronidazole precipitates out of cold solution. Tablets: below 25°C in original blister or bottle, protected from moisture. Both forms ship at controlled ambient; some IV lines may specify temperature-controlled transit on the destination regulator's terms.

Shelf life

24 months for the IV infusion bag; 36 months for the film-coated tablet. Minimum 18 months residual shelf life at dispatch across both forms, or the consignment does not leave Mumbai. Longer residuals negotiable against firm tender awards.

Pack format

IV: polyolefin infusion bag with tamper-evident overwrap, single-bag carton; Type II glass bottle available where the destination still prefers it. Tablets: PVC/PVdC-Aluminium blisters of 10 or 20, 100-tablet tender cartons, or HDPE bottles of 500 / 1000 for bulk public-sector supply.

Who we supply

Hospital pharmacies, importers and tender desks across twenty markets.

India is our origin. We do not sell into the Indian market. Metronidazole is exported only.

United Kingdom

NHS hospital pharmacies and specialist importers under the MHRA (Medicines and Healthcare products Regulatory Agency) licensed-product and specials routes. Metronidazole IV and tablets are both on UK formularies; we support wholesaler and hospital-group supply and the MHRA Specials documentation pack where an unlicensed import is required for a named patient.

Named-patient import, UK →

GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)

Through local licensed importers, against MoH tender awards and hospital-pharmacy purchase orders. CTD dossiers prepared for SFDA (Saudi Food & Drug Authority), MOHAP (UAE Ministry of Health and Prevention) and GCC central registration. Apostilled CoPP and WHO-GMP certificate included; Arabic-language patient information leaflet and regulator-style artwork prepared before dispatch.

MoH registration, GCC →

Nigeria, Kenya, Ghana, South Africa

Metronidazole is a tender workhorse. Public-sector supply through NAFDAC (Nigeria), PPB (Pharmacy and Poisons Board, Kenya), Ghana FDA and SAHPRA (South African Health Products Regulatory Authority), plus NGO and Global Fund emergency-aid procurement (MSF field hospitals, UNICEF SD). WHO-PQ (WHO Prequalification) pathway supported for the lines that carry it.

Germany

Supply via licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD Module 3 and Module 2 quality overall summary prepared for BfArM (German federal institute for drugs) recognition. Apostilled CoPP, CDSCO (Central Drugs Standard Control Organization, India) manufacturing licence and chamber-attested Certificate of Origin travel with every consignment.

Pharmacist's note

Alcohol, warfarin, and a peripheral-neuropathy ceiling — the three things to counsel on.

Three counselling points drive every metronidazole dispense. Disulfiram-like reaction with alcohol — flushing, tachycardia, nausea, vomiting within minutes; counsel strict alcohol avoidance during therapy and for 48 hours after the final dose, and check mouthwash and cough-syrup excipients. CYP2C9 and CYP3A4 inhibition — warfarin INR climbs, phenytoin and cyclosporin levels rise, lithium accumulates; check concomitant therapy and dose-adjust. Peripheral and CNS neuropathy above a cumulative 2g dose or beyond ten days of therapy — flag for review and do not roll into a second extended course without neurology input. Metallic taste in about ten per cent of patients is expected, not a toxicity signal. The IV infusion is ready-to-use at 5mg/ml and does not require reconstitution — keep the outer overwrap on for prolonged storage to protect the bag from light. Avoid in the first trimester of pregnancy unless no alternative exists.

Regulatory & quality

The documentation pack a regulator actually asks for.

Our role is manufacturer-facing. We sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides.

CTD Module 3

Full chemistry, manufacturing and controls section for both the infusion bag and the tablet, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included; Module 1 administrative sections in destination format.

CoA and MoA, per batch

HPLC assay, related substances (including 2-methyl-5-nitroimidazole impurity), dissolution for tablets, sterility and bacterial endotoxin for the IV bag, pH and particulate matter — signed by the manufacturer's authorised QC head. Per batch, not per consignment.

CoPP, WHO-GMP, MFG licence

Certificate of Pharmaceutical Product and WHO-GMP certificate issued by CDSCO (Central Drugs Standard Control Organization, India), apostilled where destination requires it. WHO-PQ prequalification records provided for lines that carry it. Notarised copies travel in the shipping pack.

Pack insert, labels, artwork

Destination-language patient information leaflet — English for the UK and anglophone Africa, Arabic for the GCC, French for francophone Africa, German for BfArM. Regulator-style labelling (MHRA SmPC style, MoH style, SAHPRA, BfArM). Artwork QC before print, not after.

Temperature control

Pre-shipment thermal validation for controlled-ambient shippers; in-transit logging where the destination regulator specifies it. Excursion protocol defined before dispatch — IV bags frozen in transit trigger a QP hold (precipitation risk), not a quiet release.

Pharmacovigilance

Local PV partner or named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Signal-detection outputs — neuropathy, C. difficile treatment failures, resistance — shared with the marketing-authorisation holder.

How the enquiry works

Molecule · strength · form · volume · destination. One working day to a quote.

  1. Send us the specifics. Form (IV infusion bag, tablet or both), strength, total bag or tablet volume, destination market, whether it is tender, hospital pharmacy or NGO emergency-aid procurement, and the target delivery window.
  2. We route to the right line. Multiple Indian WHO-GMP partner lines on the M Care roster carry metronidazole IV and tablets — some of the tablet lines are WHO-PQ listed. Registered-market preference goes to facilities with in-country dossier status; public-sector tender work goes to lines with the right price point.
  3. Commercial and regulatory offer. FOB / CIF price per form, lead time, a dossier-status note per destination (including WHO-PQ status where relevant), and the documentation pack you can expect with the shipment. Inside one working day for live enquiries.
  4. Order, produce, release, ship. QC release on the Indian side with form-specific methods (sterility and endotoxin for the IV bag, dissolution for the tablet). Ambient pharmaceutical freight; some IV lines may specify temperature-controlled transit. Arrival inspection; photo evidence of seal and overwrap integrity on request.
  5. After delivery. Batch records, CoA and transit logs archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; counselling reference for alcohol interaction, CYP interactions and neuropathy ceiling shared with the receiving pharmacy on request.
Frequently asked

Metronidazole supply — the specific questions.

What strengths and forms of metronidazole do you supply?

This spoke covers three SKUs: metronidazole 500mg/100ml solution for infusion (5mg/ml) in polyolefin ready-to-use infusion bags, and metronidazole 200mg and 400mg film-coated tablets. Tablets ship in PVC/PVdC-Aluminium blisters or HDPE bottles (100-tablet tender cartons typical; 500 / 1000-tablet bulk bottles available for public-sector supply). The topical gel, vaginal gel, oral suspension and suppository presentations are separate M Care SKUs and quoted separately.

Is the IV infusion ready-to-use or does it need reconstitution?

It is ready-to-use. The 500mg/100ml polyolefin bag contains a 5mg/ml aqueous solution — hang and infuse, no reconstitution required (unlike vancomycin or imipenem, which do). Keep the outer overwrap on the bag in prolonged storage to protect the solution from light. Do not refrigerate — metronidazole precipitates out of cold solution. Store and transport at 15-25°C; a standard controlled-ambient shipper covers most lanes.

What should a pharmacy counsel patients about alcohol while on metronidazole?

Strict alcohol avoidance during therapy and for 48 hours after the final dose. Metronidazole inhibits aldehyde dehydrogenase, and any alcohol exposure can trigger a disulfiram-like reaction within minutes — flushing, tachycardia, nausea, vomiting and headache. Check routinely-missed sources: alcohol-containing mouthwash, some cough syrups, tinctures, and food sauces reduced with wine. The reaction is unpleasant but not usually dangerous in a healthy adult; it is dose-dependent and frightens patients, so counselling is essential at dispense and again in the discharge summary.

Is metronidazole WHO-PQ listed for public-sector tender submissions?

Metronidazole tablets are on the WHO Essential Medicines List core list, and specific Indian generics are WHO-Prequalified under the WHO-PQ programme — particularly the 200mg and 400mg tablet presentations that are tender workhorses across Global Fund, UNICEF Supply Division, MSF and ministry-of-health procurements in Africa. M Care supplies from lines that carry WHO-PQ status where the tender terms specify it, and provides the prequalification record with the bid pack. Where a specific tender requires a non-PQ manufacturer, we route to an alternate WHO-GMP line and supply the equivalent dossier.

Which drug interactions should we flag for the receiving pharmacy?

Four interactions matter clinically. Warfarin — metronidazole inhibits CYP2C9, INR climbs, reduce warfarin dose and monitor. Phenytoin and cyclosporin — levels rise, check concentrations. Lithium — levels rise, consider dose reduction or alternative antibacterial. Alcohol — disulfiram-like reaction, counsel strict avoidance during and for 48 hours after therapy. Peripheral or CNS neuropathy above a cumulative 2g dose or beyond ten days of therapy is a separate flag — review before any second extended course. Full interaction reference shared with the receiving pharmacy on request.

Which markets can you ship metronidazole into?

The UK (wholesaler and hospital supply, MHRA Specials where an unlicensed import is needed for a named patient), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain — through licensed local importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Egypt — tender, hospital and NGO supply), the Philippines, and Germany (§72 AMG import channels). We do not supply into India. Full list under markets.

What are typical lead times for metronidazole orders?

For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order on both the IV bag and the tablet. Made-to-order batches run 6-10 weeks for the IV bag (sterile fill-and-finish, plus QC release) and 4-8 weeks for tablets, inclusive of destination artwork and regulator-style labelling. Air-freight transit to the UK or GCC runs 3-5 days; sea-freight to Africa, 18-28 days. Both forms travel at controlled ambient; no cold-chain surcharge applies.

Metronidazole enquiry

Send the specifics. You'll have a price inside one working day.

Form, strength, volume, destination, tender or hospital pharmacy, target delivery. That's the enquiry. WHO-PQ pathway paperwork, dossier, counselling reference — on us.

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