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Tiagabine Hydrochloride bulk supplier for pharma manufacturers

Tiagabine Hydrochloride 2 mg, 4 mg, 12 mg, 16 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 2 mg, 4 mg, 12 mg, 16 mg

Reference Brands: Gabitril (USA/EU)

Category: Neurology

Tiagabine hydrochloride tablets, 2 mg, 4 mg, 12 mg and 16 mg, a GABA reuptake inhibitor used as add-on therapy for focal seizures. For importers, hospital pharmacies and neurology services.

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Product Description:

Tiagabine is an antiepileptic that blocks GAT-1, the transporter that clears the inhibitory neurotransmitter GABA from the synapse. With less reuptake, inhibitory signalling lasts longer and the spread of seizure activity is damped. It is supplied as tiagabine hydrochloride film-coated tablets. This page lists 2 mg, 4 mg, 12 mg and 16 mg, the US strengths; some European markets use 5 mg, 10 mg and 15 mg instead. The spread of strengths reflects the slow, stepwise titration tiagabine needs.

It is licensed as add-on therapy for focal seizures in adults and adolescents aged 12 and over whose seizures are not controlled by other drugs. It is taken with food, and the dose is raised gradually over several weeks. Patients on enzyme-inducing antiepileptics such as carbamazepine or phenytoin clear it faster and need higher doses. Dizziness, tiredness, tremor and nervousness are common. Labels warn that seizures, including status epilepticus, have occurred when it was used outside epilepsy. Lower doses suit liver impairment, and withdrawal is gradual.

Sourcing notes. Tiagabine is prescription-only and demand is modest, so lead times can be longer than for first-line antiepileptics. Make sure the strengths you order match those on your national register. Request a CTD or ACTD file with bioequivalence studies and stability data for zone IVb. Tablets come in blisters or bottles that protect from moisture and light. Ask for a certificate of analysis with each lot, plus GMP evidence and a CoPP. In your enquiry, state strengths, pack size, quantity and the minimum shelf life you need on arrival.

Tiagabine Hydrochloride — third party manufacturing & bulk supply

Tiagabine Hydrochloride 2 mg, 4 mg, 12 mg, 16 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Tiagabine Hydrochloride is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Tiagabine Hydrochloride listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Tiagabine Hydrochloride is used to treat partial seizures in patients with epilepsy, usually as an add-on therapy along with other antiepileptic medicines.

Tiagabine Hydrochloride is made from the active pharmaceutical ingredient tiagabine hydrochloride, a synthetic compound that enhances GABA activity in the central nervous system.

The trade name of Tiagabine Hydrochloride is Gabitril.

It is made by a number of companies in different countries, including India. We match each enquiry with licensed makers that can supply your market.

The generic name is tiagabine hydrochloride.

The brand name is Gabitril.

Tiagabine Hydrochloride is manufactured in multiple countries, including the USA, EU nations, and India, by GMP-approved pharmaceutical manufacturers.

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