Description
Alfuzosin (Extended-Release) & Dutasteride Tablets (10 mg / 0.5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced urology, nephrology, and targeted internal medicine therapeutics. We provide ultra-high-purity, kinetically balanced Alfuzosin & Dutasteride FDC Tablets, manufactured in WHO–GMP certified, high-precision specialized oral solid dosage facilities. This “Alpha-1 Blocker & 5-Alpha Reductase Inhibitor (5-ARI) FDC” is a massive-volume strategic export to urology hospitals, men’s health clinics, and government health ministries, serving as the globally preferred intervention for Moderate-to-Severe Benign Prostatic Hyperplasia (BPH).
Product Overview
This formulation operates as a “Mechanical and Hormonal Stabilizer.” It is specifically engineered to address both the dynamic (muscle tension) and static (physical size) components of an enlarged prostate.
Mechanism 1 (The Dynamic Relaxant – Alfuzosin): As a uro-selective Alpha-1 Adrenergic Antagonist, Alfuzosin relaxes the smooth muscle in the prostate and the bladder neck. This physically opens the “pipe” (urethra), providing rapid relief from urinary hesitancy and weak stream.
Mechanism 2 (The Static Shrinker – Dutasteride): As a dual 5-Alpha Reductase Inhibitor, Dutasteride blocks the conversion of Testosterone into Dihydrotestosterone (DHT), the hormone responsible for prostate growth. By lowering DHT levels, it physically shrinks the prostate gland over time.
Mechanism 3 (The Sustained-Release Advantage): Our Alfuzosin component is engineered into an Extended-Release (ER) matrix. This ensures a steady 24-hour concentration, preventing the “first-dose hypotension” (dizziness) often seen with older alpha-blockers.
Product Composition & Strength
We supply this product as a Precision-Blended, Bi-Layer or Capsule-in-Tablet format, packed in high-barrier Alu-Alu blister strips to ensure the stability of the moisture-sensitive Dutasteride.
| Active Ingredient | Strength | Primary Clinical Function |
| Alfuzosin HCl (Extended-Release) USP/BP | 10 mg | The Rapid Reliever: Provides immediate improvement in urine flow by relaxing prostate muscles. |
| Dutasteride USP/BP | 0.5 mg | The Long-Term Shaper: Reduces the physical size of the prostate to prevent the need for surgery. |
| Excipients | Hydrophilic Matrix | Controlled-Release System: Engineered to provide synchronized 24-hour therapeutic coverage with once-daily dosing. |
Technical & Logistics Specifications
HS Code: 3004.90.99 (Medicaments containing other active substances – Urology/BPH)
CAS Numbers: 81403-68-1 (Alfuzosin) / 164656-23-9 (Dutasteride)
Dosage Form: Extended-Release Tablet / Capsule
Packaging: Alu-Alu Blisters (MANDATORY). Protects the sensitive APIs from light and environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.
Manufacturing Authority & Compliance
Uro-Selective Purity: Our manufacturing process focuses on absolute chemical purity to ensure Alfuzosin’s selectivity for the prostate over blood vessels, minimizing the risk of dizziness or low blood pressure.
Segregated Hormonal Production: Dutasteride is a potent 5-ARI. We utilize Dedicated Specialized Blocks with primary containment to ensure zero cross-contamination, meeting the strictest international safety standards for hormonal therapeutics.
Primary Indications
Urology: Treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with an enlarged prostate.
Preventative Medicine: Reduction of the risk of Acute Urinary Retention (AUR) and the need for BPH-related surgery (e.g., TURP).
Men’s Health: Improving Lower Urinary Tract Symptoms (LUTS) like frequency, urgency, and nighttime urination.
Dosage & Administration
Standard Adult Dosing: 1 tablet once daily, taken at the same time every day.
Administration: Must be taken immediately after the same meal each day. Tablets must be swallowed whole; do not crush or chew, as this destroys the extended-release mechanism.
Safety Warning: Pregnancy Caution. Women who are or may become pregnant should not handle leaking capsules/tablets, as Dutasteride can be absorbed through the skin and cause birth defects in a male fetus. Monitor for Orthostatic Hypotension (dizziness upon standing). Strictly contraindicated in patients with severe hepatic impairment.
Global Export & Contract Manufacturing
Healthy Inc is a premier Urology Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-precision BPH FDCs. Whether you are a Men’s Health Clinic Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.
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