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

Panadol (paracetamol), sold in the United States as Tylenol (acetaminophen), is licensed for pain and fever across oral, rectal and intravenous routes, and it remains one of the most extensively genericised molecules on any hospital formulary, with tablets, paediatric suspension and IV infusion all available as licensed generic lines alongside the originator brands.

M Care Exports supplies paracetamol, marketed internationally as Panadol by Haleon (formerly GSK Consumer Healthcare) and in the United States as Tylenol by Kenvue, an oral, rectal and intravenous non-opioid analgesic and antipyretic that sits on almost every hospital, tender and retail formulary. M Care Exports is a merchant exporter: we source Panadol/Tylenol and licensed generic paracetamol tablets, paediatric suspension and intravenous solution for infusion, including the Perfalgan brand line, 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

Paracetamol exporter and bulk supplier from India.

For hospital pharmacy, wholesaler and MoH tender-desk orders, M Care quotes paracetamol against buyer specification: oral tablets or paediatric oral suspension, rectal suppository, or intravenous solution for infusion; brand (Panadol/Tylenol/Perfalgan) or generic; and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. IV paracetamol solution for infusion is supplied in three weight-restricted vial sizes: 10mL/100mg for patients up to 10kg (including neonates), 50mL/500mg for patients over 10kg up to 33kg, and 100mL/1000mg for patients over 33kg. We confirm the buyer's formulation, weight band and current lead time before dispatch, 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

Non-opioid analgesic and antipyretic; aniline (para-aminophenol) derivative, sourced and documented for export.

Paracetamol (the international non-proprietary name; acetaminophen is the adopted name used in the United States) is a non-opioid analgesic and antipyretic, chemically an aniline (para-aminophenol) derivative, whose mechanism is understood to act centrally rather than through the peripheral cyclo-oxygenase inhibition typical of NSAIDs, which is why it lacks their gastrointestinal and antiplatelet effects. It carries no anti-inflammatory licence in most markets, distinguishing it from ibuprofen and other NSAIDs on the same pain-and-fever shelf. It is dosed orally, rectally or intravenously, with the IV route needing no reconstitution but requiring correct vial selection by patient weight. Panadol/Tylenol-line strengths supplied are 500mg film-coated tablets, 120mg/5mL and 250mg/5mL oral suspension for children, and 10mg/mL solution for infusion presented as 10mL (100mg), 50mL (500mg) and 100mL (1000mg) vials for 15-minute IV infusion, including the Perfalgan brand line.

Active ingredient

Paracetamol (acetaminophen). Non-opioid analgesic and antipyretic; aniline (para-aminophenol) derivative.

Forms and strengths

500 mg film-coated tablet; 120 mg/5mL oral suspension; 250 mg/5mL oral suspension; 10 mg/mL solution for infusion (100mg/10mL, 500mg/50mL and 1000mg/100mL weight-banded vials).

Indications

Paracetamol, a non-opioid analgesic and antipyretic used for pain and fever, licensed across oral, rectal and intravenous routes. Supplied as originator Panadol/Tylenol/Perfalgan and licensed generic lines from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.

Administration

Oral, Rectal, Intravenous. Film-coated tablet, oral suspension, suppository and solution for infusion.

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 paracetamol are hospital pharmacies stocking it as a baseline analgesic and antipyretic across every ward, anaesthesia and post-operative teams using the IV line for multimodal, opioid-sparing pain control, paediatric wards and community formularies using the 120mg/5mL and 250mg/5mL suspensions, national and regional MoH tender desks that list paracetamol on their essential-medicines schedule, NGO and foundation procurement programmes (Global Fund, UNICEF, MSF-type buyers) sourcing it as a core primary-care commodity, and licensed pharmaceutical wholesalers, importers and retail chains across our GCC and African markets.

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 paracetamol.

Standard adult oral dosing is 500mg to 1000mg every four to six hours, and while UK and US OTC labelling has historically permitted up to 4g in 24 hours, many prescribers and several national bodies now apply a tighter 3g/24h ceiling for standard-strength retail packs, particularly in patients under 50kg, with hepatic impairment, or with regular alcohol use, so formulary guidance should be checked rather than assumed. The IV line carries the same total-daily-dose logic but by weight and vial: the 10mL/100mg vial is for patients up to 10kg including neonates, the 50mL/500mg vial for patients over 10kg up to 33kg, and the 100mL/1000mg vial for patients over 33kg, infused over 15 minutes, at least four hours apart, to a maximum of four doses or 3g in 24 hours, whichever is lower. The clinical risk that dominates every label is hepatotoxicity from exceeding the maximum dose or from stacking multiple paracetamol-containing products (a common error with combination cold-and-flu remedies), which is why dispensing counsel should always ask what else the patient is already taking. Paracetamol is not a controlled substance in the markets we review; only opioid-combination products built on it (paracetamol/codeine, paracetamol/tramadol) carry separate controlled-drug scheduling and licensing. No cold-chain handling is required for tablets, suspension or the IV solution, all of which store at controlled room temperature and should not be frozen; the IV solution should also be kept in its outer carton to protect it from light.

Regulatory & quality

The documentation pack a regulator actually asks for.

As oral, rectal and ambient-stable IV dosage forms, paracetamol travels on standard temperature-controlled logistics rather than 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 market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Paracetamol has sat on the WHO Model List of Essential Medicines since 1977 for pain and since 1987 for acute migraine, and appears on the WHO Model List of Essential Medicines for Children in oral liquid and suppository form; it carries no AWaRe (Access, Watch, Reserve) classification, because that framework applies only to antibiotics, not analgesics. On the brand-versus-generic question, Panadol (Haleon, most markets outside the US) and Tylenol (Kenvue, US) remain the recognised consumer brands, and Perfalgan (Bristol-Myers Squibb) remains a recognised IV brand internationally; paracetamol is nonetheless one of the most extensively genericised molecules in global pharmacy, with licensed generic tablets, suspension and injectable solution registered from multiple manufacturers in essentially every regulated and semi-regulated market, so buyers have a genuine and largely interchangeable brand-or-generic choice. In the US, the once-standard IV brand Ofirmev was discontinued by its manufacturer in 2021 once a generic premix acetaminophen injection became available, so generic IV acetaminophen is now the standard US product. M Care confirms current lead times per formulation before quoting a tender.

The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.

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.

Related general & otc molecules

Adjacent lines procurement desks order alongside paracetamol.

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 paracetamol.
  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

Paracetamol supply, the specific questions.

Does a generic version of Panadol or Tylenol exist?

Yes, and it is one of the most widely available generics in pharmacy. Licensed generic paracetamol tablets, paediatric suspension and injectable solution for infusion are registered from multiple manufacturers in virtually every regulated and semi-regulated market, alongside the Panadol (Haleon), Tylenol (Kenvue, US) and Perfalgan (IV) brand lines. Registration status still varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.

What is the maximum daily dose of paracetamol, and why does the ceiling vary?

Adult oral dosing is typically 500mg to 1000mg every four to six hours. UK and US labelling has historically allowed up to 4g in 24 hours, but many prescribers and several national bodies now apply a tighter 3g/24h ceiling for standard-strength retail packs, particularly for patients under 50kg or with liver risk factors. The IV line follows the same logic by weight-restricted vial size, capped at 3g in 24 hours. Destination-market labelling should be confirmed before a formulary decision.

How does IV paracetamol differ from the oral and suspension forms?

IV paracetamol, including the Perfalgan brand line, is a 10mg/mL solution for infusion supplied in three weight-banded vials: 10mL/100mg for patients up to 10kg including neonates, 50mL/500mg for patients over 10kg up to 33kg, and 100mL/1000mg for patients over 33kg, infused over 15 minutes and at least four hours apart. It is used mainly for post-operative and multimodal, opioid-sparing pain control where oral dosing is not practical. Oral tablets and paediatric suspension cover routine ward and outpatient use. All forms need no cold-chain handling.

Is paracetamol on the WHO Essential Medicines List?

Yes. Paracetamol has been on the WHO Model List of Essential Medicines since 1977 for pain and since 1987 for acute migraine, and it also appears on the WHO Model List of Essential Medicines for Children in oral liquid and suppository form. It carries no AWaRe (Access, Watch, Reserve) classification, since that framework applies only to antibiotics.

Is there a current shortage affecting paracetamol supply?

Shortage status changes and differs by formulation and market, so we do not publish a standing claim. The FDA's drug shortage database is the public reference for the US. M Care confirms current manufacturer availability and lead time for each formulation at quote stage.

What documentation does M Care provide with a paracetamol shipment?

Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import, along with clear confirmation of which brand or generic product, and which dosage form, 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 2026-09-19.

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.

Paracetamol 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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