Xeljanz (tofacitinib) is supplied by M Care as Pfizer's originator brand; the underlying US composition-of-matter patent expired in December 2025, so every enquiry should confirm current brand-versus-generic status for the destination market rather than assume originator-only supply is fixed.
Xeljanz and Xeljanz XR (tofacitinib) are Pfizer's oral JAK inhibitor for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. M Care sources the originator brand through licensed Indian distribution channels and dispatches against tender and hospital orders across the GCC, Africa and Europe. We do not manufacture; we are a merchant exporter working within CDSCO-licensed export routes.
Tofacitinib exporter and bulk supplier from India.
For MoH tenders and hospital formulary orders, the Mumbai desk quotes Xeljanz tablets, Xeljanz XR extended-release tablets and the paediatric oral solution against confirmed purchase orders, with CTD/eCTD-ready documentation and batch-specific certificates of analysis for each dispatch. Because M Care has not identified a locally registered generic equivalent in the markets it currently serves, quotes today are for the originator brand sourced through licensed channels; the underlying patent position changed in December 2025, so this should be reconfirmed for each destination market rather than assumed fixed.
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.
Janus kinase (JAK) inhibitor, sourced and documented for export.
Tofacitinib is an oral Janus kinase (JAK) inhibitor, preferentially targeting JAK1 and JAK3, which interrupts cytokine signalling implicated in inflammatory joint and bowel disease.
FDA-licensed indications: moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis, each after inadequate response or intolerance to one or more TNF blockers. A paediatric indication (age 2 and above) covers active psoriatic arthritis and active polyarticular course juvenile idiopathic arthritis, also after TNF-blocker failure.
Available as Xeljanz immediate-release tablets (5 mg, 10 mg), Xeljanz XR extended-release tablets (11 mg, 22 mg) and a 1 mg/mL oral solution for paediatric and swallowing-difficulty use. All are oral solid or solution formulations held at controlled room temperature; there is no cold-chain requirement for this product, unlike M Care's biologic injectable lines.
Active ingredient
tofacitinib citrate. Janus kinase (JAK) inhibitor.
Forms and strengths
5 mg tablet; 10 mg tablet; 11 mg XR tablet; 22 mg XR tablet; 1 mg/mL oral solution.
Indications
Oral JAK inhibitor licensed for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, and psoriatic arthritis and polyarticular course juvenile idiopathic arthritis in children aged 2 and above, following inadequate response or intolerance to a TNF blocker.
Administration
oral. Film-coated tablet, extended-release tablet, and oral solution.
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 Xeljanz typically include rheumatology and gastroenterology departments at private and NHS-linked hospitals in the UK and Gulf, MoH tender desks sourcing second-line biologic DMARD alternatives for national formularies, and licensed importers and wholesalers stocking specialist immunology ranges in Nigeria, Kenya, South Africa and the Levant. NGO procurement for tofacitinib is uncommon relative to biosimilar biologics, since it sits later in most treatment algorithms after TNF-blocker failure.
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 tofacitinib.
Dosing differs by indication and by formulation. The RA and PsA dose is 5 mg twice daily (or 11 mg XR once daily); UC induction uses 10 mg twice daily for at least 8 weeks before stepping down to 5 mg twice daily for maintenance in most patients. Confirm the indication on the order before substituting tablet strength for XR strength: 5 mg twice daily and 11 mg XR once daily are the matched pair, not 10 mg and 22 mg, which is the UC-induction pairing.
Xeljanz is contraindicated for combination with biologic DMARDs or potent immunosuppressants such as azathioprine or cyclosporine; flag this on any hospital order that also lists a biologic, since co-prescribing is a labelling violation, not just a caution.
Screen for latent tuberculosis and viral hepatitis before dispatch-linked initiation and monitor lymphocyte counts, neutrophil counts, haemoglobin and lipids per the label's laboratory schedule; procurement teams supplying tender lots should expect the receiving hospital to ask for this monitoring cadence in their formulary submission.
As no generic tofacitinib is currently registered with the regulators in the markets M Care serves, there is ordinarily no INN-brand substitution decision to manage at the pharmacy counter here, unlike biosimilar-eligible biologics; M Care will flag if that changes for a given destination market. Every unit currently dispensed against an M Care-supplied order is the Pfizer-sourced Xeljanz or Xeljanz XR brand.
The documentation pack a regulator actually asks for.
Xeljanz ships as an oral solid or solution, so the documentation chain is batch-release certificates, CDSCO export permissions and CTD-format dossiers rather than cold-chain validation logs; M Care still runs the same eCTD-ready paperwork discipline it applies to its temperature-sensitive biologic lines, so tender desks receive consistent batch traceability regardless of product type.
On the brand question: tofacitinib's US composition-of-matter patent expired in December 2025, and generic tofacitinib tablets (5 mg and 10 mg) have since been approved and launched in the US market. M Care has not identified a registered generic equivalent in the GCC, African or European markets it currently serves, so quotes there remain for the originator Xeljanz brand. Buyers should treat that as a position to be reconfirmed at each tender cycle rather than assumed indefinitely, given the US patent position has already moved.
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 tofacitinib.
Adalimumab
Another allergy & immunology line ordered on the same formularies.
Dupilumab
Another allergy & immunology line ordered on the same formularies.
Etanercept
Another allergy & immunology line ordered on the same formularies.
All allergy & immunology
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 tofacitinib.
- 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.
Tofacitinib supply, the specific questions.
Is there a generic version of Xeljanz (tofacitinib) available to supply?
Generic tofacitinib tablets (5 mg and 10 mg) have been approved and launched in the US following the December 2025 expiry of the composition-of-matter patent. M Care has not identified a registered generic equivalent in the UK, GCC or African markets it currently serves, so quotes for those markets remain for the originator Xeljanz or Xeljanz XR brand, sourced through licensed Indian distribution channels; ask M Care to reconfirm generic status for your destination market, as this position is moving.
Can M Care supply Xeljanz to a hospital or MoH tender outside India?
Yes. M Care is an Indian export house, not a domestic Indian supplier, so every Xeljanz order is structured for destination-market import: we prepare CDSCO export documentation and CTD-ready dossiers, and the buyer's own import licence or MoH registration governs entry into their country.
What strengths and formulations of Xeljanz can be quoted?
Xeljanz immediate-release tablets in 5 mg and 10 mg, Xeljanz XR extended-release tablets in 11 mg and 22 mg, and the 1 mg/mL oral solution for paediatric or swallowing-impaired patients.
Does Xeljanz require cold-chain shipping?
No. Tofacitinib tablets, XR tablets and oral solution are stored at controlled room temperature, not refrigerated, so this product moves on standard pharmaceutical freight rather than the validated cold-chain lanes M Care runs for its injectable biologics.
What is the boxed warning on Xeljanz and why does it matter for procurement?
The FDA label carries a boxed warning covering serious infections (including tuberculosis), increased mortality, malignancy, major adverse cardiovascular events and thrombosis, based on a large postmarketing safety study comparing tofacitinib to TNF blockers. Receiving hospitals will typically require this risk information in their formulary submission, so M Care includes the current prescribing information with every dossier.
Which indications is Xeljanz licensed for?
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, and psoriatic arthritis and polyarticular course juvenile idiopathic arthritis in children aged 2 and above, in each case after an inadequate response or intolerance to one or more TNF blockers. Confirm any other licensed indication against destination-country labelling before quoting.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
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.