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Dutasteride + Tamsulosin bulk supplier for pharma manufacturers

Dutasteride + Tamsulosin 0.5 mg + 0.4 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 0.5 mg + 0.4 mg

Reference Brands: Jalyn (USA), Dutamul (India), Duodart (EU)

Category: Urology

Dutasteride + Tamsulosin is a Urology product available as Capsules in strengths 0.5 mg + 0.4 mg. It corresponds to the reference brands Jalyn (USA), Dutamul (India), Duodart (EU). 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:

Fixed-dose dutasteride/tamsulosin is a combination therapy used for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic enlargement (BPE). This formulation contains two active ingredients: tamsulosin and dutasteride. Tamsulosin is an α-adrenoceptor blocker that is relatively selective for the α1A-adrenoceptor subtype in the smooth muscles of the prostate, bladder neck, and prostatic urethra. By inhibiting these receptors, tamsulosin promotes relaxation of smooth muscle, improving urinary flow and relieving symptoms such as weak stream, hesitancy, and frequent urination.

Dutasteride is a 5α-reductase inhibitor that blocks the conversion of testosterone to dihydrotestosterone (DHT) in the prostate, liver, and skin. By reducing DHT levels, dutasteride causes shrinkage of prostatic epithelium and decreases overall prostate size, addressing the structural component of BPE.

Although no clinical studies have specifically evaluated the fixed-dose combination tablet, multiple trials on combination therapy of 5α-reductase inhibitors and α-adrenoceptor blockers, including the CombAT study, have shown significant improvements in LUTS symptom scores compared to monotherapy with either agent. This evidence supports the rationale for combining dutasteride and tamsulosin into a single tablet, offering both symptomatic relief and long-term reduction in prostate size in men with BPE.

Dutasteride + Tamsulosin — third party manufacturing & bulk supply

Dutasteride + Tamsulosin 0.5 mg + 0.4 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 Dutasteride + Tamsulosin 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

Dutasteride + Tamsulosin is used for the treatment of moderate to severe benign prostatic hyperplasia (BPH) in men with enlarged prostates. It improves urine flow and relieves symptoms such as difficulty in urination, weak stream, and frequent urination.

This combination capsule contains dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin hydrochloride, an alpha-1 adrenergic receptor antagonist, both produced via controlled pharmaceutical synthesis and formulated together as extended-release oral capsules.

Trade names include Jalyn (USA), Duodart (EU), and multiple regional brands in emerging markets such as Dutamul and Duomax (India).

Jalyn is marketed in the USA by GlaxoSmithKline, Duodart in the EU by GlaxoSmithKline or licensed partners, and generics in India and other emerging markets are manufactured by multiple pharmaceutical companies.

The generic name is dutasteride and tamsulosin hydrochloride.

Common brand names include Jalyn, Duodart, Dutamul, and Duomax.

Dutasteride + Tamsulosin capsules are manufactured by GlaxoSmithKline and licensed partners in the USA, EU, India, and other emerging markets depending on the brand or generic manufacturer.

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