Tolcapone 100 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 100 mg

Reference Brands: Tasmar (USA/EU)

Category: Neurology

Tolcapone 100 mg film-coated tablets, a COMT inhibitor added to levodopa in Parkinson's disease under liver monitoring, for importers, distributors and hospital pharmacies in markets where it is registered.

Product Description:

Tolcapone is a catechol-O-methyltransferase (COMT) inhibitor used only together with levodopa. COMT breaks down levodopa in the gut wall and body; blocking it gives steadier, longer-lasting levodopa levels, so each dose works for longer. Unlike entacapone, tolcapone also enters the brain and inhibits COMT there. It is supplied as 100 mg film-coated tablets taken three times a day, with the first tablet taken together with the first levodopa dose of the day.

It is prescribed in Parkinson's disease for patients on levodopa with a decarboxylase inhibitor who have end-of-dose fluctuations and, under European labelling, only when other COMT inhibitors have failed or are not tolerated. Rare fatal liver failure has occurred, so liver enzymes are checked before and frequently during treatment, and the drug is stopped if they rise or there is no clear benefit within three weeks. Levodopa often needs reducing to limit dyskinesia. Diarrhoea is common, urine may turn bright yellow, and non-selective MAO inhibitors are avoided.

Sourcing notes. Registration is limited: the European authorisation was suspended for some years over liver toxicity and later restored with strict conditions, and many markets have no product registered, so check status before quoting. Expect a CTD dossier with bioequivalence data and stability for your climatic zone, including IVb for hot humid markets. Blisters or bottles need no cold chain. Ask for a CoA per batch with assay, dissolution and related substances, the GMP certificate, a CoPP and any risk minimisation material your regulator requires. It is prescription-only. Specify strength, pack size and label language.