Preservex (aceclofenac) is licensed for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and its twice-daily 100mg dosing keeps it a steady formulary NSAID alongside diclofenac on the tender lists M Care supplies.
M Care Exports is a merchant exporter: we source Preservex and long-genericised aceclofenac 100mg film-coated tablets through licensed Indian manufacturing and distribution channels and dispatch on quote, not from our own production.
Aceclofenac exporter and bulk supplier from India.
For hospital, wholesaler and MoH tender orders, M Care quotes aceclofenac against buyer specification: brand or generic, pack size and destination-market regulatory documentation. Because aceclofenac carries the same class-wide NSAID cardiovascular and gastrointestinal caution as its parent compound diclofenac, and a third-trimester pregnancy contraindication, we confirm the buyer's intended formulary counselling material and pack-insert language 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.
Non-steroidal anti-inflammatory drug (NSAID); phenylacetic acid derivative, a diclofenac analogue, sourced and documented for export.
Aceclofenac is a phenylacetic-acid derivative NSAID, structurally a diclofenac analogue that is metabolised in part to diclofenac in vivo. It inhibits cyclo-oxygenase, reducing prostaglandin synthesis to relieve pain and inflammation, with a somewhat COX-2-preferential profile compared with diclofenac. It is dosed orally only; no reconstitution is needed. The UK-licensed indication for Preservex 100mg film-coated tablets covers relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis; the Spanish-licensed Airtal brand additionally covers acute inflammatory pain such as lumbago, toothache and shoulder periarthritis, so destination-country labelling should be checked against this before a tender quote is finalised. Aceclofenac is supplied as a 100mg film-coated tablet, taken as two separate 100mg doses (200mg daily) with or after food; Airtal is also registered in Spain as a powder for oral suspension, so buyers with a liquid-formulation requirement should flag this at enquiry stage.
Active ingredient
Aceclofenac. Non-steroidal anti-inflammatory drug (NSAID); phenylacetic acid derivative, a diclofenac analogue.
Forms and strengths
100 mg film-coated tablet.
Indications
Aceclofenac is a phenylacetic-acid NSAID, structurally related to diclofenac, indicated for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Supplied from Indian manufacturing channels as both the Preservex brand and long-genericised aceclofenac 100mg tablets, to regulated and semi-regulated export markets.
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 aceclofenac are hospital rheumatology, orthopaedic and general-practice pharmacies stocking a standard chronic-pain and inflammatory-arthritis NSAID line, national and regional MoH tender desks running musculoskeletal and pain-management formulary lists, licensed pharmaceutical wholesalers and importers, and primary-care procurement programmes supplying a baseline NSAID 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.
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 aceclofenac.
Aceclofenac's dosing is fixed and simple, 100mg twice daily with food, which is exactly why the class-wide NSAID caution is the point worth restating on every dispensing label: the emc SmPC carries the standard gastrointestinal bleeding, ulceration and perforation warning and the cardiovascular thrombotic-event caution shared across the NSAID class, so lowest effective dose for shortest duration is the working rule. Aceclofenac is contraindicated in established congestive heart failure, ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, in active or recurrent peptic ulcer disease, and in the third trimester of pregnancy; hepatic impairment calls for an initial 100mg daily dose rather than the standard 200mg. There is no paediatric dosing data and the medicine is not recommended in children. Because aceclofenac is partly metabolised to diclofenac, a patient already counselled on diclofenac's warnings should have that history checked before a switch, and any concurrent lithium, digoxin or methotrexate therapy needs the same plasma-level vigilance a diclofenac prescription would trigger.
The documentation pack a regulator actually asks for.
As an oral NSAID with no biologic component, aceclofenac ships on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for insulins and biologics; the emc SmPC specifies storage below 30°C with a shelf life of up to three years from manufacture. What buyers need instead is the standard batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires local registration, CTD or eCTD-format dossier support. Aceclofenac is not carried on the current WHO Model List of Essential Medicines. It is not a scheduled controlled substance in the markets M Care serves. The molecule has been off-patent for years, with Accord Healthcare among the licensed UK generic manufacturers alongside the Preservex brand, and separately marketed and regulator-approved in Spain as Airtal, which keeps tender volume steady on a genericised NSAID rather than dependent on a single originator supply line.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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 aceclofenac.
Deflazacort
Another musculoskeletal & pain line ordered on the same formularies.
Denosumab
Another musculoskeletal & pain line ordered on the same formularies.
Diclofenac
Another musculoskeletal & pain line ordered on the same formularies.
All musculoskeletal & pain
The full category listing for procurement desks.
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 aceclofenac.
- 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.
Aceclofenac supply, the specific questions.
Does a generic version of Preservex exist?
Yes. Aceclofenac has been off-patent for years, with Accord Healthcare among the licensed UK manufacturers of generic aceclofenac 100mg tablets alongside the Preservex brand. M Care quotes brand or generic against your tender specification and destination-market registration status.
Which international brand names does aceclofenac go by?
Preservex is the name used in the UK, marketed by Almirall. The same molecule is separately regulator-approved and marketed as Airtal in Spain. Destination-market labelling and pack artwork should be confirmed against the specific brand name your tender or formulary specifies.
What strength and form of aceclofenac can M Care supply?
A 100mg film-coated tablet, dosed as two separate 100mg doses (200mg daily), one in the morning and one in the evening, with or after food. Airtal is also registered in Spain as a powder for oral suspension. Tell us your dosing protocol, indication mix and volume and we quote the pack format accordingly.
Is aceclofenac on the WHO Essential Medicines List?
No. Aceclofenac does not appear on the current WHO Model List of Essential Medicines. It nonetheless remains a widely prescribed NSAID on national formularies across the GCC and Africa for chronic inflammatory-arthritis and musculoskeletal-pain management.
Does aceclofenac need cold-chain shipping?
No. Aceclofenac film-coated tablets are stored at controlled room temperature, below 30 degrees Celsius, and move on standard ambient logistics, not the validated cold-chain lanes we use for biologics and vaccines.
Is aceclofenac approved in the United States?
No. Aceclofenac is not FDA-approved and is not marketed in the United States. It is licensed and widely prescribed across the UK, the EU, the Middle East and Asia, which are among the markets M Care exports into.
What documentation does M Care provide with an aceclofenac shipment?
A batch-specific 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, alongside confirmation of exactly which brand or generic product a shipment contains.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.