GLN-URSODIOL 500 MG
URSODIOL : 500 MG · DIN 02426919 · GLENMARK PHARMACEUTICALS CANADA INC.
Health Canada status: MARKETED
What is GLN-URSODIOL?
GLN-URSODIOL 500 MG contains URSODIOL : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 02426919, held by GLENMARK PHARMACEUTICALS CANADA INC., supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 23-Jul-2021. 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 GLN-URSODIOL used for?
Management of cholestatic liver diseases, such as primary biliary cirrhosis (PBC).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02426919 |
|---|---|
| Brand name | GLN-URSODIOL |
| Generic / active ingredient | URSODIOL : 500 MG |
| Manufacturer | GLENMARK PHARMACEUTICALS CANADA INC. |
| Strength | 500 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A05AA02 URSODEOXYCHOLIC ACID |
| AHFS class | 56:14.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 23-Jul-2021 |
| Original market date | 2016-04-04 00:00:00 |
How is it administered?
Recommended adult dosage for PBC is 13-15 mg/kg/day administered in two to four divided doses with food. 500 mg tablets are scored and can be halved.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in provided text (Section 11 header present but content missing). Standard USP storage typically applies.
How is it supplied?
Bottles of 100 and 500 tablets.
Contraindications
Hypersensitivity to ursodiol; complete biliary obstruction of extrahepatic origin; widespread intrahepatic obstruction.
Warnings and precautions
Monitor liver function tests regularly. Rare reports of bezoars in patients with intestinal stenosis. Caution in patients with variceal bleeding or hepatic encephalopathy.
What can be used instead?
Other Canadian products sharing ATC code A05AA02 URSODEOXYCHOLIC ACID. 8 of 26 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| GLN-URSODIOL | 250 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | DIN 02426900 |
| JAMP-URSODIOL | 250 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02472392 |
| JAMP-URSODIOL | 500 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02472406 |
| NRA-URSODIOL | 250 MG | TABLET | NORA PHARMA INC | MARKETED | DIN 02544032 |
| NRA-URSODIOL | 500 MG | TABLET | NORA PHARMA INC | MARKETED | DIN 02544024 |
| PMS-URSODIOL C | 250 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02273497 |
| PMS-URSODIOL C | 500 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02273500 |
| AG-URSODIOL | 250 MG | TABLET | ANGITA PHARMA INC. | DORMANT | DIN 02505363 |
| AG-URSODIOL | 500 MG | TABLET | ANGITA PHARMA INC. | DORMANT | DIN 02505371 |
| DOM-URSODIOL C | 250 MG | TABLET | DOMINION PHARMACAL | CANCELLED POST MARKET | DIN 02281295 |
Who else supplies URSODEOXYCHOLIC ACID worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. URSODEOXYCHOLIC ACID appears in 48 registered pack listings across 8 markets, published on 7 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.