WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Xylocaine (lidocaine hydrochloride) is the amide local anaesthetic behind most infiltration, nerve-block and epidural procedures on a theatre list, and it sits on the WHO Essential Medicines List.

M Care Exports supplies Xylocaine, AstraZeneca's originator lidocaine hydrochloride injection, alongside multi-manufacturer generic lidocaine that already covers most hospital formularies. It anaesthetises by blocking sodium channels along the nerve fibre, and at a lower systemic dose the same drug treats ventricular arrhythmia. M Care is a merchant exporter: we source Xylocaine and generic lidocaine through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

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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
Bulk supply and export terms

Lidocaine exporter and bulk supplier from India.

For hospital pharmacy, day-surgery and MoH tender orders, M Care quotes lidocaine hydrochloride injection against buyer specification: brand (Xylocaine) or generic, plain or with epinephrine, and strength (0.5%, 1%, 1.5% or 2%), drawn from licensed WHO-GMP manufacturer lines on the M Care roster. We confirm current lot availability and pack format before quoting, 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.

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At a glance

Amide-type local anaesthetic; Class Ib antiarrhythmic (at lower systemic dose), sourced and documented for export.

Lidocaine is an amide-type local anaesthetic that blocks voltage-gated sodium channels in nerve membranes, stopping the initiation and conduction of the nerve impulse that carries pain signals. The same channel-blocking action, at lower systemic doses, suppresses ectopic ventricular activity, which is why the same molecule appears twice on a hospital formulary under two different uses. The originator's US labelling covers infiltration, peripheral nerve block and intravenous regional anaesthesia; the UK SmPC additionally covers epidural and caudal use and adds treatment of ventricular extrasystoles and ventricular tachycardia at the 2% strength. It is dosed by weight, with a standard adult ceiling of 4.5 mg/kg or 300 mg for infiltration and nerve block without epinephrine, rising to 7 mg/kg or 500 mg with epinephrine. Lidocaine hydrochloride is supplied as 0.5%, 1%, 1.5% and 2% w/v solutions for injection in single-dose and multi-dose ampoules or vials, plain or with epinephrine 1:100,000 or 1:200,000.

Active ingredient

Lidocaine hydrochloride. Amide-type local anaesthetic; Class Ib antiarrhythmic (at lower systemic dose).

Forms and strengths

0.5 % w/v (5 mg/mL) solution for injection; 1 % w/v (10 mg/mL) solution for injection; 1.5 % w/v (15 mg/mL) solution for injection; 2 % w/v (20 mg/mL) solution for injection.

Indications

Lidocaine hydrochloride, amide local anaesthetic used for infiltration, nerve block, epidural and caudal anaesthesia, and at lower systemic dose for ventricular arrhythmia. Supplied as originator Xylocaine and licensed generic injection from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.

Administration

Infiltration, Nerve block, Epidural, Intravenous. Solution for injection.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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 lidocaine are hospital anaesthesia and day-surgery pharmacies stocking a theatre-list local anaesthetic, emergency and cardiac units holding the antiarrhythmic strength for peri-arrest use, national and regional MoH tender desks running essential-medicines and surgical-list procurement, licensed pharmaceutical wholesalers and importers covering dermatology, dental, ophthalmic and podiatry clinics, and NGO or field-surgery programmes that treat lidocaine as a baseline theatre-kit item rather than a discretionary purchase.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on lidocaine.

Lidocaine dosing is weight-based and route-specific: infiltration and nerve block cap at 4.5 mg/kg or 300 mg in adults without epinephrine, rising to around 7 mg/kg or 500 mg when epinephrine is co-administered to slow systemic absorption (UK SmPC guidance sets a lower 200 mg ceiling without epinephrine, so buyers should check the destination label), while the antiarrhythmic strength is dosed by a separate, much lower bolus-and-infusion protocol that should never be confused pack-for-pack with the anaesthetic strength on a crash-cart shelf. Plain solutions and epinephrine-containing solutions should be stored and labelled distinctly, since the wrong pick during a nerve block can precipitate cardiovascular collapse rather than the intended vasoconstriction. Xylocaine's labelling carries a standing warning that infiltration and nerve-block use should only be undertaken where oxygen, resuscitative drugs and cardiopulmonary equipment are immediately to hand, reflecting the real risk of local anaesthetic systemic toxicity (LAST) from inadvertent intravascular injection. No reconstitution is required and no cold chain applies; ampoules and vials store below 25°C, protected from light, with a shelf life of 36 months from manufacture per the UK SmPC.

Regulatory & quality

The documentation pack a regulator actually asks for.

As a ready-to-use ampoule or vial, lidocaine travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Lidocaine hydrochloride with epinephrine injection is on the WHO Model List of Essential Medicines in 1% and 2% strengths, making it a standing tender-list item across GCC and African MoH essential-medicines schedules rather than a discretionary line. On the brand-versus-generic question, Xylocaine remains the AstraZeneca originator, but FDA-approved and MHRA/EMA-licensed generic lidocaine hydrochloride injection from several manufacturers is already the dominant hospital purchase in most markets, so buyers genuinely have a brand-or-generic choice, subject to current lot availability.

Buyers new to sourcing from India usually read the licensed import route explainer first, then the product 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.

How the enquiry works

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

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for lidocaine.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Lidocaine supply, the specific questions.

Does a generic version of Xylocaine exist?

Yes, and it already accounts for most hospital purchasing. FDA-approved and MHRA/EMA-licensed generic lidocaine hydrochloride injection is manufactured by several companies alongside the originator Xylocaine brand from AstraZeneca. Registration status and current lot availability vary by destination country and by manufacturer, so M Care checks both before quoting brand or generic against a specific tender.

Why is lidocaine injection sometimes hard to source?

Injectable lidocaine sits on a structurally thin supply base: a small number of manufacturers hold most of the market, none of the active pharmaceutical ingredient is made domestically in several buyer markets, and margins on a decades-old generic are low relative to demand. M Care works from multiple WHO-GMP sourcing lines precisely because a single-manufacturer position is fragile for this molecule.

What strengths of lidocaine injection does M Care supply?

0.5%, 1%, 1.5% and 2% w/v solutions for infiltration, nerve block, epidural and intravenous regional anaesthesia, plain or with epinephrine 1:100,000 or 1:200,000. Tell us your procedure mix and pack format, ampoule or vial, single-dose or multi-dose, and we quote accordingly.

Is lidocaine on the WHO Essential Medicines List?

Yes. Lidocaine hydrochloride with epinephrine injection appears on the WHO Model List of Essential Medicines in 1% and 2% strengths, with a 2% strength also listed for dental cartridge use. This makes it a standing item on most MoH essential-medicines tenders rather than a discretionary purchase.

Can plain lidocaine and lidocaine-with-epinephrine be mixed up on a shelf?

They should never be. Both come in visually similar ampoules at the same percentage strengths, but epinephrine-containing solutions carry separate contraindications, including intraocular and digit or appendage use, where vasoconstriction can compromise blood supply. We recommend destination-market labelling and shelf segregation follow the same distinct-storage practice hospital pharmacies already apply, and we flag the plain-versus-epinephrine split clearly on every shipment.

What documentation does M Care provide with a lidocaine 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 which brand or generic product and which strength, plain or with epinephrine, a shipment contains.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.

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.

Lidocaine enquiry

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.

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