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

Ponstan (mefenamic acid) is licensed for dysmenorrhoea and short-course mild-to-moderate pain, and licensed generic mefenamic acid capsules, tablets and paediatric suspension now sit alongside the originator brand on hospital and retail formularies.

M Care Exports supplies Ponstan (mefenamic acid), a fenamate NSAID originated by Parke-Davis and marketed internationally as Ponstan by Pfizer, alongside FDA- and MHRA-licensed generic mefenamic acid lines. It is prescribed short-course for dysmenorrhoea and mild-to-moderate pain, not as a long-term anti-inflammatory. M Care is a merchant exporter: we source Ponstan and generic mefenamic acid through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

Also marketed as Ponstel.

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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

Mefenamic acid exporter and bulk supplier from India.

For hospital pharmacy, wholesaler and retail-chain orders, M Care quotes mefenamic acid against buyer specification: brand (Ponstan/Ponstan Forte) or generic, capsule, tablet or paediatric suspension, and destination-market regulatory documentation. Because US labelling restricts use to seven days for pain and the US label carries a boxed warning for NSAID-class cardiovascular and gastrointestinal risk, matched by equivalent warnings in the UK SmPC, we confirm the buyer's intended formulary placement and patient information leaflet 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

Fenamate non-steroidal anti-inflammatory drug (NSAID); non-selective COX-1/COX-2 inhibitor, sourced and documented for export.

Mefenamic acid is a fenamate-class non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory and antipyretic activity, working by non-selective inhibition of cyclo-oxygenase (COX-1 and COX-2) to reduce prostaglandin synthesis. In the uterus this lowers the prostaglandin levels associated with menstrual pain and heavy bleeding, which is why dysmenorrhoea and menorrhagia are its most distinctive licensed uses among common NSAIDs. The FDA label restricts mefenamic acid capsules to management of mild-to-moderate pain in patients 14 years and older for no more than seven days, and to treatment of primary dysmenorrhoea; the UK SmPC for Ponstan Forte extends further to rheumatoid arthritis, osteoarthritis, muscular, traumatic, dental and post-operative pain, headache, and menorrhagia from dysfunctional causes or intrauterine device use, plus pyrexia in children via the paediatric suspension. It is an oral-only therapy, needing no reconstitution. Mefenamic acid is supplied as 250mg capsules, 500mg film-coated tablets (branded as Ponstan Forte) and a 50mg/5mL oral suspension for children unable to swallow solid dose forms.

Active ingredient

mefenamic acid. Fenamate non-steroidal anti-inflammatory drug (NSAID); non-selective COX-1/COX-2 inhibitor.

Forms and strengths

250 mg capsule; 500 mg film-coated tablet; 50 mg/5mL oral suspension.

Indications

Fenamate NSAID with analgesic, anti-inflammatory and antipyretic activity, licensed for short-course mild-to-moderate pain and primary dysmenorrhoea, with UK licensing extending to arthritis, general pain and menorrhagia.

Administration

oral. Capsule, film-coated tablet and oral suspension.

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 mefenamic acid are hospital gynaecology and pain-management pharmacies stocking a dysmenorrhoea and menorrhagia line, paediatric wards and community paediatric formularies using the 50mg/5mL suspension for pyrexia and juvenile pain, national and regional MoH tender desks running women's-health and analgesic procurement lists, licensed pharmaceutical wholesalers and importers, and retail pharmacy chains across our GCC and African markets stocking an over-the-counter or pharmacist-supervised analgesic range where local scheduling permits.

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 mefenamic acid.

Adult dosing for pain is 500mg initially then 250mg every six hours as needed, usually capped at seven days per the FDA label; UK dosing for arthritis and general pain is 500mg three times daily with meals, while dysmenorrhoea and menorrhagia dosing starts at symptom onset per the prescriber's protocol. Children under 12 take the 50mg/5mL suspension rather than a solid dose form; confirm weight-band dosing at dispensing since paediatric prescribing is not simply a fraction of the adult capsule strength. Mefenamic acid carries the same NSAID-class cardiovascular thrombotic and gastrointestinal bleeding, ulceration and perforation warnings as other fenamates, and US labelling adds an explicit contraindication in the peri-operative setting of coronary artery bypass graft surgery. Avoid use from 30 weeks of pregnancy onward because of the risk of premature closure of the fetal ductus arteriosus, and use the lowest effective dose for the shortest duration between 20 and 30 weeks, monitoring for oligohydramnios if treatment runs beyond 48 hours. Cross-sensitivity with aspirin and other NSAIDs means a documented aspirin-exacerbated respiratory reaction should stop dispensing at the counter. No reconstitution and no cold chain are required; capsules, tablets and suspension all store at controlled room temperature.

Regulatory & quality

The documentation pack a regulator actually asks for.

As an oral solid and oral liquid dosage form, mefenamic acid 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; UK shelf life runs three years in amber polystyrene bottles and four years in blister packs and HDPE containers, per the Ponstan Forte SmPC. Mefenamic acid does not appear on the WHO Model List of Essential Medicines; the NSAIDs WHO does list for pain and inflammation are ibuprofen and acetylsalicylic acid, so tender desks should treat mefenamic acid as a formulary-specific choice for dysmenorrhoea and short-course pain rather than an EML first-line analgesic. On the brand-versus-generic question, Ponstan (and Ponstan Forte for the 500mg tablet) remains the originator line internationally, developed by Parke-Davis and marketed by Pfizer; in the US, mefenamic acid is sold under the Ponstel brand, currently marketed by Avion Pharmaceuticals, and FDA-approved generic mefenamic acid 250mg capsules from multiple manufacturers are also registered and marketed there. Licensed generic mefenamic acid tablets and suspension are separately available in the UK. Buyers genuinely have a brand-or-generic choice on formulary; M Care quotes either against the tender specification and destination-market registration status. Mefenamic acid is not a controlled substance in the markets we currently review.

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 mefenamic acid.
  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

Mefenamic acid supply, the specific questions.

Does a generic version of Ponstan exist?

Yes. FDA-approved generic mefenamic acid 250mg capsules from multiple manufacturers are registered and marketed in the US alongside the branded Ponstel line, currently distributed by Avion Pharmaceuticals. Licensed generic mefenamic acid tablets and 50mg/5mL suspension are also available in the UK alongside the Ponstan and Ponstan Forte brand. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.

What is mefenamic acid licensed to treat?

US labelling covers management of mild-to-moderate pain in patients 14 years and older for up to seven days, and treatment of primary dysmenorrhoea. UK labelling for Ponstan Forte extends further to rheumatoid arthritis, osteoarthritis, muscular, traumatic and dental pain, headache, post-operative pain, and menorrhagia from dysfunctional causes or intrauterine device use, plus pyrexia in children via the suspension. Check destination-country labelling before a tender submission.

What strengths and forms of mefenamic acid does M Care supply?

250mg capsules, 500mg film-coated tablets matching the Ponstan Forte strength, and a 50mg/5mL oral suspension for children who cannot swallow solid dose forms. Tell us your buyer mix, hospital, retail or paediatric formulary, and we quote the strength and pack format accordingly.

Is mefenamic acid safe to use in later pregnancy?

No, not from 30 weeks onward, because of the risk of premature closure of the fetal ductus arteriosus and neonatal renal impairment. Between 20 and 30 weeks, US labelling calls for the lowest effective dose for the shortest duration, with monitoring for oligohydramnios if treatment runs beyond 48 hours. This is standard NSAID-class guidance, not unique to mefenamic acid, and should be reflected in destination-market patient information leaflets.

Is mefenamic acid on the WHO Essential Medicines List?

No. Mefenamic acid does not appear on the WHO Model List of Essential Medicines; the NSAIDs WHO lists for pain and inflammation are ibuprofen and acetylsalicylic acid. Tender desks typically specify mefenamic acid as a formulary-specific option for dysmenorrhoea and short-course pain rather than an EML first-line analgesic.

What documentation does M Care provide with a mefenamic acid 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 confirmation of which brand or generic product 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 2026-09-13.

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.

Mefenamic acid enquiry

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