Agomelatine bulk supplier for pharma manufacturers

Agomelatine 25 mg, 50 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 25 mg, 50 mg

Reference Brands: Valdoxan (EU/UK)

Category: Psychiatry / Mental Health

Agomelatine 25 mg and 50 mg film-coated tablets, a melatonergic antidepressant for adult major depression, for pharmacy distributors, hospital buyers and importers supplying markets where it is registered.

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Product Description:

Agomelatine is an antidepressant with a mode of action unlike SSRIs and SNRIs. It stimulates melatonin MT1 and MT2 receptors and blocks serotonin 5-HT2C receptors, which is thought to help reset disturbed sleep-wake rhythms and raise frontal noradrenaline and dopamine release. This page lists film-coated tablets at 25 mg and 50 mg. Many reference labels have only the 25 mg tablet, with 50 mg taken as two, so check which strengths your market registers.

It is approved in the EU and other regions for major depressive episodes in adults, but not in the United States. Treatment starts at 25 mg at bedtime and may rise to 50 mg after two weeks. Liver injury is the main safety issue. Liver tests are needed before starting, at set points in the first months and after a dose increase. It is contraindicated in hepatic impairment and with potent CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin.

Sourcing notes. Agomelatine is prescription-only. Registration usually needs a CTD or ACTD dossier with bioequivalence against the reference 25 mg tablet. Ask whether the regulator requires a patient booklet on liver monitoring, as some do, and plan the local-language version. Tablets are normally in aluminium blisters; confirm label storage and ask for stability data matching your climatic zone. Request a CoA with each batch, the GMP certificate and a CoPP. If you need 50 mg, confirm it is registrable in the destination before ordering.

Agomelatine — third party manufacturing & bulk supply

Agomelatine 25 mg, 50 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

Agomelatine 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 Agomelatine 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

Agomelatine is used to treat major depressive disorder (MDD) in adults. It helps improve mood, reduce symptoms of depression such as sadness and loss of interest, and restore normal sleep patterns by regulating the circadian rhythm.

Agomelatine is a synthetic pharmaceutical compound that acts as a melatonergic antidepressant. It functions as an agonist at melatonin MT1 and MT2 receptors and as an antagonist at serotonin 5-HT2C receptors to balance neurotransmitters and improve depressive symptoms.

Agomelatine is marketed under the brand name Valdoxan in Europe and several other countries, and as Thymanax in some emerging markets.

Agomelatine (Valdoxan) is manufactured and marketed by Servier Laboratories in Europe and distributed in other regions through authorized partners.

The generic name is Agomelatine.

The most recognized brand name is Valdoxan.

Agomelatine is manufactured in regulated pharmaceutical facilities that comply with international quality and safety standards, primarily in Europe, with distribution to other approved markets.