CELLCEPT 250 MG — DIN 02192748
MYCOPHENOLATE MOFETIL : 250 MG · HOFFMANN-LA ROCHE LIMITED · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is CELLCEPT?
CELLCEPT 250 MG contains MYCOPHENOLATE MOFETIL : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02192748, held by HOFFMANN-LA ROCHE LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 31-Dec-1995. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is CELLCEPT used for?
CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids. CellCept i.v. is an alternative dosage form to CellCept capsules, tablets and oral suspension. CellCept i.v. should be administered within 24 hours following transplantation. CellCept i.v. can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication. In pediatric patients (2 to 18 years) CellCept is indicated for the prophylaxis of organ rejection receiving allogeneic renal transplants, and should be used concomitantly with cyclosporine and corticosteroids.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Mycophenolic Acid in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
16 holders have a Canadian DIN containing Mycophenolic Acid, across 41 DINs, of which 24 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| HOFFMANN-LA ROCHE LIMITED | 4 | 4 | CELLCEPT, CELLCEPT I.V. | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 4 | 4 | JAMP MYCOPHENOLIC ACID, JAMP-MYCOPHENOLATE, JAMP-MYCOPHENOLATE CAPSULES | Sourceable in Canada |
| ACCORD HEALTHCARE INC | 4 | 3 | ACH-MYCOPHENOLATE, MYCOPHENOLATE MOFETIL FOR INJECTION, USP | Sourceable in Canada |
| MARCAN PHARMACEUTICALS INC | 3 | 3 | MAR-MYCOPHENOLATE MOFETIL, MAR-MYCOPHENOLIC ACID | Sourceable in Canada |
| APOTEX INC | 6 | 2 | APO-MYCOPHENOLATE, APO-MYCOPHENOLATE MOFETIL, APO-MYCOPHENOLIC ACID | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 4 | 2 | SANDOZ MYCOPHENOLATE MOFETIL, SANDOZ MYCOPHENOLIC ACID | Sourceable in Canada |
| NOVARTIS PHARMACEUTICALS CANADA INC | 2 | 2 | MYFORTIC | Sourceable in Canada |
| SANIS HEALTH INC | 2 | 2 | MYCOPHENOLATE MOFETIL | Sourceable in Canada |
| TEVA CANADA LIMITED | 2 | 2 | TEVA-MYCOPHENOLATE | Sourceable in Canada |
| ACCEL PHARMA INC | 2 | 0 | ACCEL-MYCOPHENOLATE MOFETIL CAPSULES, ACCEL-MYCOPHENOLATE MOFETIL TABLETS | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 2 | 0 | MYLAN-MYCOPHENOLATE | No marketed DIN |
| VANC PHARMACEUTICALS INC | 2 | 0 | VAN-MYCOPHENOLATE | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 250 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | CellCept capsules are oblong, blue/brown, two-piece hard gelatin capsules, printed in black with "CellCept 250" on the blue cap and "Roche" on the brown body. They are provided in unit dose of 10 capsules in blister packs, 10 packs per box. CellCept tablets are lavender coloured, caplet-shaped, film coated tablets, engraved with “CellCept 500" on one side and “Roche” on the other. They are provided in unit dose of 10 tablets in blister packs, 5 packs per box. CellCept powder for oral suspension is supplied as a white to off-white powder blend for reconstitution to a white to off-white fruit flavour suspension. It is provided in a 225 mL bottle with bottle adapter and 2 oral dispensers*. The deliverable volume after reconstitution is 165 mL. CellCept i.v. is supplied in a 20 mL, sterile vial containing the equivalent of 500 mg MMF, as the hydrochloride salt in cartons of 4 vials. Each vial is intended for single use only. |
| Storage | Store reconstituted suspension at 15 - 30ºC. Do not freeze. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Mycophenolic Acid |
|---|---|
| ATC code | L04AA06 |
| AHFS class | 90:28.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02192748 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2192748 |
| Brand name | CELLCEPT |
| Generic / active ingredient | MYCOPHENOLATE MOFETIL : 250 MG |
| Market authorization holder | HOFFMANN-LA ROCHE LIMITED |
| Health Canada schedule | Prescription |
| ATC code | L04AA06 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L04AA |
| Current status | MARKETED |
| Status date | 31-Dec-1995 |
| Original market date | 1995-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
24 of 41 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACH-MYCOPHENOLATE | 250 MG | CAPSULE | ACCORD HEALTHCARE INC | MARKETED | 02383780 |
| ACH-MYCOPHENOLATE | 500 MG | TABLET | ACCORD HEALTHCARE INC | MARKETED | 02378574 |
| APO-MYCOPHENOLIC ACID | 360 MG | TABLET (ENTERIC-COATED) | APOTEX INC | MARKETED | 02372746 |
| APO-MYCOPHENOLIC ACID | 180 MG | TABLET (ENTERIC-COATED) | APOTEX INC | MARKETED | 02372738 |
| CELLCEPT | 200 MG | POWDER FOR SUSPENSION | HOFFMANN-LA ROCHE LIMITED | MARKETED | 02242145 |
| CELLCEPT | 500 MG | TABLET | HOFFMANN-LA ROCHE LIMITED | MARKETED | 02237484 |
| CELLCEPT I.V. | 500 MG | POWDER FOR SOLUTION | HOFFMANN-LA ROCHE LIMITED | MARKETED | 02240347 |
| JAMP MYCOPHENOLIC ACID | 360 MG | TABLET (ENTERIC-COATED) | JAMP PHARMA CORPORATION | MARKETED | 02518511 |
| JAMP MYCOPHENOLIC ACID | 180 MG | TABLET (ENTERIC-COATED) | JAMP PHARMA CORPORATION | MARKETED | 02518538 |
| JAMP-MYCOPHENOLATE | 500 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02380382 |
2 · Same class — other molecules in ATC L04AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Mycophenolic Acid | ACCEL-MYCOPHENOLATE MOFETIL CAPSULES · ACCEL-MYCOPHENOLATE MOFETIL TABLETS · ACH-MYCOPHENOLATE · AG-MYCOPHENOLATE · +21 more | 41 | 24 | Yes |
| Apremilast | APO-APREMILAST · APO-APREMILAST TABLETS · AURO-APREMILAST · GLN-APREMILAST · +7 more | 22 | 11 | Yes |
| Abatacept | ORENCIA | 3 | 2 | Yes |
| Antilymphocyte Immunoglobulin (Horse) | ATGAM · ATGAM STERILE SOLUTION IV 50MG/ML | 2 | 1 | Yes |
| Cladribine | MAVENCLAD | 1 | 1 | Yes |
| Efgartigimod Alfa | VYVGART | 1 | 1 | Yes |
| Belumosudil | REZUROCK | 1 | 1 | Yes |
| Antithymocyte Immunoglobulin (Rabbit) | THYMOGLOBULIN | 1 | 1 | Yes |
| Alefacept | AMEVIVE | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC L04A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L04AX | Azathioprine · Dimethyl Fumarate · Lenalidomide · Methotrexate · Other Immunosuppressants · +3 more | 191 | 124 |
| L04AC | Anakinra · Basiliximab · Bimekizumab · Brodalumab · Canakinumab · +13 more | 85 | 75 |
| L04AB | Adalimumab · Certolizumab Pegol · Etanercept · Golimumab · Infliximab | 71 | 55 |
| L04AD | Ciclosporin · Tacrolimus | 49 | 30 |
| L04AK | Leflunomide · Teriflunomide | 44 | 25 |
| L04AH | Everolimus · Sirolimus | 36 | 23 |
| L04AF | Baricitinib · Deucravacitinib · Ritlecitinib · Tofacitinib · Upadacitinib | 23 | 19 |
| L04AG | Alemtuzumab · Anifrolumab · Belimumab · Efalizumab · Inebilizumab · +7 more | 20 | 15 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.