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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), Thymanax (India/ Middle East)

Category: Psychiatry / Mental Health

Agomelatine is a Psychiatry / Mental Health product available as Tablets in strengths 25 mg, 50 mg. It corresponds to the reference brands Valdoxan (EU/UK), Thymanax (India/ Middle East). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Agomelatine is a novel antidepressant with a unique mechanism of action, functioning as a melatonergic agonist and a 5-HT2C antagonist. This dual activity helps regulate the sleep-wake cycle and improves mood by promoting the release of norepinephrine and dopamine in the brain. It is primarily used to treat major depressive disorder (MDD) in adults, offering benefits for both psychiatric and primary care patients who have not achieved full remission with conventional antidepressants.

One of the distinguishing features of agomelatine is its favorable side-effect profile. It is generally well-tolerated, with minimal risk of sexual dysfunction, weight gain, or discontinuation syndrome, and it is relatively safe in cases of overdose. However, a small percentage of patients may experience elevated liver enzymes, which requires monitoring during treatment. Agomelatine’s ability to improve sleep patterns while alleviating depressive symptoms makes it a promising option for patients struggling with persistent depression. With further clinical evaluation, it may become a valuable addition to the available pharmacological strategies for managing depression in diverse healthcare settings.

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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Agomelatine listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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