Galantamine Prolonged-Release Capsules 8 mg, 16 mg, 24 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 8 mg, 16 mg, 24 mg

Reference Brands: Razadyne ER (US), Reminyl XL (UK)

Category: Neurology

Galantamine 8 mg prolonged-release capsules, a prescription acetylcholinesterase inhibitor and the usual starting strength for Alzheimer's dementia. Aimed at importers, distributors, hospital pharmacies and memory clinic buyers.

Product Description:

Galantamine is a prescription medicine for dementia of the Alzheimer type. It reversibly inhibits acetylcholinesterase, so more acetylcholine stays available at nerve endings in the brain, and it also sharpens the response of nicotinic receptors. The molecule was first found in snowdrop bulbs and is now made by synthesis or extraction. This page covers 8 mg capsules. In registered products, galantamine capsules are a prolonged-release form taken once a day, and 8 mg is the starting strength.

Galantamine is used for mild to moderately severe Alzheimer's dementia. Dosing begins at 8 mg each morning with food for four weeks, then usually rises to 16 mg, sometimes 24 mg. After a break of more than a few days, it is restarted at the lowest dose. Nausea and weight loss are common early on. Its vagal effect can slow the heart and cause fainting, and care is taken with conduction disorders, peptic ulcer, asthma or COPD and seizures. Paroxetine and ketoconazole raise galantamine levels.

Sourcing notes. Handle this as a registered prescription medicine and check that the offer is a prolonged-release capsule with its own registration, not an unregistered supplement. Ask for a CTD or ACTD dossier with bioequivalence data and dissolution profiles that prove the prolonged release, plus zone IVb stability for tropical markets. Capsules come in blisters or bottles at room temperature. Documents to request are a CoA per batch, the GMP certificate and a CoPP. Give the titration strengths needed, pack size, label language and expected volumes.