Etoricoxib's dose strength follows the diagnosis, not the severity, and ordering the wrong strength orders the wrong indication.
Etoricoxib's dose strengths are not interchangeable points on a severity scale: each is licensed to a specific condition, and one of them is licensed for only eight days. M Care stocks 27 etoricoxib tablet lines across the 60mg, 90mg and 120mg strengths, sourced from WHO-GMP certified Indian manufacturers, for regulated importers across the EU, UK, Gulf, Africa, Latin America, Southeast Asia and CIS markets where the molecule is authorized. Etoricoxib has never been approved for the United States market.
Etoricoxib exporter and bulk supplier from India.
Export documentation for etoricoxib shipments includes the Certificate of Pharmaceutical Product, Certificate of Origin, and a manufacturer-issued Certificate of Analysis confirming compliance with the pharmacopoeial specification (USP, BP or Ph. Eur. as required) for each of the 27 stocked lines. Because etoricoxib is contraindicated in pregnancy and in severe hepatic or renal impairment, M Care ensures the outbound package insert and product literature accompanying each consignment match the destination market's approved labelling rather than a generic summary. Tablets are packed to standard pharmaceutical export specification for ambient-temperature transit. Import permits and free-sale certificates are coordinated per shipment to match the receiving country's registration requirements, and M Care's CDSCO export licence and ISO 9001:2015 certification accompany the compliance file on request.
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.
COX-2 selective non-steroidal anti-inflammatory drug (coxib), sourced and documented for export.
Etoricoxib dosing is indication-locked rather than severity-scaled. Under EU and UK labelling, 60mg is the maintenance ceiling for osteoarthritis and also the starting dose for rheumatoid arthritis and ankylosing spondylitis; 90mg is the maintenance ceiling for those two inflammatory conditions and is separately the dose for short-term acute pain, including post-dental-surgery pain, capped at three days; and 120mg is reserved for acute gouty arthritis alone, capped at a maximum of eight days, and is never appropriate as ongoing maintenance therapy. A purchase order that names the wrong strength therefore names the wrong therapeutic tier, not simply a smaller or larger amount of the same treatment. M Care stocks 27 etoricoxib tablet lines across these three strengths, sourced from WHO-GMP certified Indian manufacturers, for regulated importers across the EU, UK, Gulf, Africa, Latin America, Southeast Asia and CIS markets where etoricoxib is authorized. Etoricoxib has never been approved for the United States market.
Active ingredient
Etoricoxib. COX-2 selective non-steroidal anti-inflammatory drug (coxib).
Forms and strengths
60 mg; 90 mg; 120 mg.
Indications
Etoricoxib is a COX-2 selective NSAID indicated for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and short-term management of acute pain, including acute gouty arthritis and post-dental-surgery pain, with each strength licensed to a specific indication and, for acute gout, a specific maximum duration of eight days. It was never granted US FDA approval and remains contraindicated in established cardiovascular disease, pregnancy and significant renal or severe hepatic impairment. M Care Exports supplies oral tablet lines only, sourced from WHO-GMP certified Indian manufacturers, into markets where etoricoxib holds valid marketing authorization.
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 are hospital procurement units, tender desks and licensed pharmaceutical importers in the European Union, the United Kingdom, Gulf and GCC states, sub-Saharan and North Africa, Latin America, Southeast Asia and the CIS, the jurisdictions where etoricoxib carries marketing authorization. Rheumatology and orthopaedic formularies order the 60mg and 90mg tiers for maintenance therapy across osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, while tender desks stocking for acute gout protocols draw on the 120mg line, which is time-capped at eight days rather than held as running maintenance stock. Regulatory affairs teams managing multi-country registration dossiers value a supplier that will not present US approval status inaccurately, since etoricoxib carries none.
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 etoricoxib.
A reviewing pharmacist checking an etoricoxib line should confirm the strength matches both the intended indication and its treatment duration, not just the diagnosis category. Under EU and UK labelling, 60mg is the maintenance ceiling for osteoarthritis and the starting dose for rheumatoid arthritis and ankylosing spondylitis; 90mg is the maintenance ceiling for rheumatoid arthritis and ankylosing spondylitis and is also the dose for short-term acute pain, including post-dental-surgery pain, capped at three days; and 120mg is licensed for acute gouty arthritis only, capped at a maximum of eight days, and is not a chronic maintenance strength. Cardiovascular contraindications are absolute rather than relative: established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure NYHA class II to IV, and uncontrolled hypertension persistently above 140/90 mmHg all rule out use. Renal dosing is a hard cutoff, not a reduction: etoricoxib is contraindicated below 30 mL/min creatinine clearance. Severe hepatic impairment, defined in labelling as a Child-Pugh score of 10 or above, is also an absolute contraindication rather than a dose-reduction trigger. As a COX-2 selective agent it lacks antiplatelet effect and is not a substitute for low-dose aspirin in cardiovascular prophylaxis, a distinction worth flagging on any combined cardiology and rheumatology formulary review.
The documentation pack a regulator actually asks for.
Each etoricoxib line ships with a Certificate of Analysis from the manufacturing site, batch manufacturing and testing records available on request, and a Certificate of Pharmaceutical Product structured to the destination regulator's format where required for import registration. Because etoricoxib's New Drug Application was never approved by the FDA, there is no FDA establishment or product listing to cite, and buyers running comparative dossiers should reference the EU or UK marketing authorization and SmPC rather than a US label. M Care operates as a merchant-exporter under a CDSCO export licence and holds ISO 9001:2015 certification for its quality management system; it does not hold, and does not claim, WHO-GMP or WHO-PQ certification, which sit with the manufacturing sites it sources from. Documentation is compiled per consignment to match the importing country's registration and customs requirements, including pharmacopoeial compliance statements (BP, Ph. Eur. or USP as specified) for each stocked strength, and is available for regulatory affairs review before shipment confirmation.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Etoricoxib has never received US FDA marketing approval; FDA's Arthritis Advisory Committee voted 20 to 1 against approval in 2007 over cardiovascular risk, and the drug has not subsequently gained US approval.
Contraindicated in established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, and congestive heart failure NYHA class II to IV.
Contraindicated in uncontrolled hypertension persistently above 140/90 mmHg.
Contraindicated in pregnancy and during breastfeeding.
Contraindicated at creatinine clearance below 30 mL per minute; contraindicated in severe hepatic impairment (Child-Pugh score of 10 or above).
Under EU/UK SmPC labelling, 60mg is the maintenance ceiling for osteoarthritis and the starting dose for rheumatoid arthritis and ankylosing spondylitis; 90mg is the maintenance ceiling for rheumatoid arthritis and ankylosing spondylitis and the dose for short-term acute pain including post-dental-surgery pain (maximum 3 days); 120mg is licensed for acute gouty arthritis only, for a maximum of 8 days, and is not a maintenance strength.
Adjacent lines procurement desks order alongside etoricoxib.
Deflazacort
Another musculoskeletal & pain line ordered on the same formularies.
Febuxostat
Another musculoskeletal & pain line ordered on the same formularies.
Methylprednisolone
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 etoricoxib.
- 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.
Etoricoxib supply, the specific questions.
Which etoricoxib strength is appropriate for acute gout versus long-term arthritis therapy?
Under EU and UK labelling, 60mg is the maintenance ceiling for osteoarthritis and the starting dose for rheumatoid arthritis and ankylosing spondylitis, and 90mg is the maintenance ceiling for rheumatoid arthritis and ankylosing spondylitis as well as the dose for short-term acute pain, including post-dental-surgery pain, capped at three days. The 120mg strength is reserved for acute gouty arthritis alone, for a maximum of eight days, and is not a chronic maintenance dose. Substituting 120mg into a long-term arthritis order supplies the wrong therapeutic tier, not simply a stronger dose of the same treatment.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, so it does not hold WHO-GMP or WHO-PQ certification itself. Those certifications sit with the Indian manufacturing sites it sources etoricoxib from. M Care's own credentials are ISO 9001:2015 certification and a CDSCO export licence, and buyers requiring manufacturer-level WHO-GMP evidence receive it as part of the site documentation pack.
Why is etoricoxib not approved for the United States market?
The FDA's Arthritis Advisory Committee voted twenty to one against approval in 2007, citing cardiovascular risk relative to comparator NSAIDs in Merck's MEDAL trial data, and the FDA subsequently declined to approve the drug. Etoricoxib has not gained US approval since. It remains authorized and prescribed across the European Union, the United Kingdom and a number of other countries, none of which is the United States.
What cardiovascular contraindications apply to etoricoxib?
Etoricoxib is contraindicated, not merely cautioned, in patients with established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure NYHA class II to IV, and uncontrolled hypertension persistently above 140/90 mmHg. As a COX-2 selective agent it also lacks antiplatelet effect and cannot substitute for aspirin in cardiovascular prophylaxis.
Can M Care supply etoricoxib as a capsule, injectable or oral suspension?
No. M Care's catalogue holds 27 etoricoxib lines and every one is an oral tablet, at 60mg, 90mg or 120mg. Capsule, injectable, oral suspension and other dosage forms exist for etoricoxib in some markets but are not part of M Care's stocked range, and the company will not represent otherwise.
Is etoricoxib supplied by M Care as a fixed-dose combination?
No. All 27 etoricoxib lines in M Care's catalogue are single-ingredient tablets, at 60mg, 90mg or 120mg. None combines etoricoxib with another active substance, so buyers building a combination-product tender should look elsewhere in M Care's catalogue rather than expect a fixed-dose etoricoxib option.
What documentation accompanies an etoricoxib export shipment?
Each consignment includes a Certificate of Analysis from the manufacturing site, a Certificate of Origin, and a Certificate of Pharmaceutical Product structured to the destination regulator's format where the importing country requires it for registration. Pharmacopoeial compliance (BP, Ph. Eur. or USP as specified) is confirmed per stocked strength, and batch manufacturing records are available to regulatory affairs teams on request.
Is etoricoxib safe to prescribe in pregnancy or significant renal impairment?
No. Etoricoxib is contraindicated in pregnancy and during breastfeeding, and is contraindicated, not dose-reduced, in patients with creatinine clearance below 30 mL per minute. Severe hepatic impairment, defined as a Child-Pugh score of 10 or above, is also an absolute contraindication. These are labelled restrictions buyers should carry into their own market's prescribing information rather than treat as general NSAID caution.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.
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