Celebrex (celecoxib) is a COX-2 selective NSAID licensed for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and licensed generic celecoxib capsules now sit alongside the originator brand on most formularies M Care ships against.
M Care Exports supplies Celebrex (celecoxib), the COX-2 selective NSAID originated by G.D. Searle and now distributed by Viatris in the United States, alongside licensed generic celecoxib capsules. It is a formulary alternative for patients who cannot tolerate a non-selective NSAID's gastrointestinal risk. M Care is a merchant exporter: we source Celebrex and licensed generic celecoxib through Indian distribution and WHO-GMP manufacturing channels and dispatch on quote, not from our own manufacturing.
Celecoxib exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and tender-desk orders, M Care quotes celecoxib against buyer specification: brand (Celebrex) or generic, 100mg or 200mg hard capsules, and destination-market regulatory documentation. Because celecoxib carries a boxed cardiovascular and gastrointestinal warning and is contraindicated in sulfonamide-allergic patients, 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 from licensed WHO-GMP manufacturer lines on the M Care roster.
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 (NSAID), sulfonamide class, sourced and documented for export.
Celecoxib is a COX-2 selective non-steroidal anti-inflammatory drug: it inhibits cyclo-oxygenase-2 preferentially over COX-1, which lowers prostaglandin-driven inflammation and pain while sparing more of the gastric-protective COX-1 pathway than a non-selective NSAID does. That selectivity is the whole commercial reason a tender desk asks for celecoxib by name rather than a cheaper generic ibuprofen or diclofenac line: it is the option for patients with a documented ulcer history or on concurrent anticoagulation who still need an NSAID. The UK generic SmPC licenses celecoxib for symptomatic relief in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis only; the US FDA label carries a wider set that also covers juvenile rheumatoid arthritis, acute pain and primary dysmenorrhoea, so buyers should check which indication set their own destination-country labelling supports before a quote is finalised. Celecoxib is oral, dosed once or twice daily, and needs no reconstitution or cold chain. It is not on the WHO Model List of Essential Medicines and is not a controlled substance in any market M Care ships to.
Active ingredient
Celecoxib. COX-2 selective non-steroidal anti-inflammatory drug (NSAID), sulfonamide class.
Forms and strengths
100 mg hard capsule; 200 mg hard capsule.
Indications
Celecoxib (Celebrex) is a COX-2 selective NSAID licensed for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, with acute pain and primary dysmenorrhoea additionally licensed on the US label. Supplied from Indian WHO-GMP facilities as brand or licensed generic capsules to regulated and semi-regulated export markets.
Administration
Oral. Hard capsule.
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 celecoxib are mainly hospital rheumatology and orthopaedic pharmacies stocking a GI-sparing NSAID line, MoH and NHS tender desks running a musculoskeletal-pain formulary, and licensed importers restocking retail chains after a manufacturer discontinuation elsewhere in the supply chain. Original-brand Celebrex volumes are shrinking as licensed generics take formulary share on price; M Care quotes both so a buyer can specify brand-only, generic-only, or a mixed lot without re-tendering. Destination sets typically split 100mg for maintenance dosing and 200mg for once-daily osteoarthritis regimens, with the higher 400mg strength rarely stocked outside acute-pain-labelled 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 celecoxib.
Celecoxib is a sulfonamide: screen for a documented sulfonamide-allergy history before dispensing, since cross-reactivity is a labelled contraindication, not a soft caution. Dosing is condition-specific rather than a single default: 200mg once daily or 100mg twice daily for osteoarthritis, up to 200mg twice daily for rheumatoid arthritis, and destination labelling determines whether an acute-pain or dysmenorrhoea regimen is even licensed at that site. CYP2C9 poor metabolisers (CYP2C9*3/*3) accumulate celecoxib more slowly and should start at half the lowest recommended dose, or use alternative management in juvenile rheumatoid arthritis. The boxed warning covers both cardiovascular thrombotic risk (myocardial infarction, stroke) and the class-wide NSAID gastrointestinal bleeding risk, and celecoxib is contraindicated for pain immediately after coronary artery bypass graft surgery. No reconstitution, no light-sensitivity handling and no cold chain apply; capsules store below 30 degrees C with a three-year shelf life on the generic SmPC.
The documentation pack a regulator actually asks for.
Every celecoxib shipment travels with CTD Module 3 CMC documentation, per-batch Certificate of Analysis and Manufacture, CDSCO-issued Certificate of Pharmaceutical Product and WHO-GMP manufacturing licence (apostilled or notarised as the destination regulator requires), destination-language pack inserts and pre-print artwork QC, and a named pharmacovigilance contact for the registration. Ambient-only logistics mean no thermal validation pack is needed, but M Care still confirms the destination market's own indications list against the label in the shipping pack, since celecoxib's licensed uses genuinely differ between the US FDA and UK/EU labelling.
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.
Adjacent lines procurement desks order alongside celecoxib.
Aceclofenac
Another musculoskeletal & pain line ordered on the same formularies.
Allopurinol
Another musculoskeletal & pain line ordered on the same formularies.
Deflazacort
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 celecoxib.
- 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.
Celecoxib supply, the specific questions.
Is Celebrex still under patent, or is generic celecoxib available for tender?
Celecoxib's patents have expired in the US and EU and licensed generic capsules are approved and marketed alongside Celebrex; the UK emc lists multiple licensed generic manufacturers for both the 100mg and 200mg strengths. M Care quotes brand or generic to specification, so a tender desk is not limited to originator pricing to secure supply.
What strengths of celecoxib does M Care supply?
M Care's standard export lines are 100mg and 200mg hard capsules, the two strengths that cover the licensed osteoarthritis, rheumatoid arthritis and ankylosing spondylitis dosing ranges on most destination-market labelling. The 50mg and 400mg strengths exist on the US label for juvenile rheumatoid arthritis and acute pain respectively; we can source these against a confirmed order but they are not held as standard stock.
Why would a formulary choose celecoxib over a cheaper NSAID like ibuprofen or diclofenac?
Celecoxib's COX-2 selectivity is associated with a lower rate of gastrointestinal ulceration and bleeding than non-selective NSAIDs at equivalent anti-inflammatory doses, which is why it sits on formularies as the option for patients with a peptic ulcer history, concurrent anticoagulation or another GI-bleed risk factor. It is not a first-line replacement for ibuprofen or diclofenac across the board: it carries its own boxed cardiovascular warning and is contraindicated in patients with established ischaemic heart disease or a sulfonamide allergy, so the choice is patient-specific, not simply substitutable.
Does celecoxib's licensed use differ between our export markets?
Yes, and buyers should check this before ordering. The US FDA label licenses celecoxib for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhoea. The UK generic SmPC licenses only osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. M Care aligns the pack insert and patient information leaflet to whichever indication set the destination regulator has actually approved, rather than shipping a single generic label across markets.
Is celecoxib a controlled substance or a scheduled drug in the markets M Care serves?
No. Celecoxib carries no controlled-substance schedule under the US Controlled Substances Act or equivalent GCC and African narcotics-control frameworks, so it moves through ordinary prescription-only import and tender channels rather than a controlled-drug licence pathway. The regulatory attention it does require is around its boxed cardiovascular and gastrointestinal warning, which sits in standard pharmacovigilance and labelling documentation, not narcotics control.
Can M Care supply celecoxib into India?
No. M Care is an export house and does not sell into the Indian domestic market; India is our sourcing origin, not a served destination. Our celecoxib lines ship to hospital pharmacies, importers and tender desks across our export markets in the UK, EU, GCC and Africa.
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.
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.