Description
Tamsulosin & Finasteride Tablets
Healthy Inc is a specialized global supplier and exporter of advanced urological, men’s health, and hormonal therapeutics. We provide ultra-high-purity, kinetically segregated Tamsulosin Hydrochloride (0.4 mg MR) & Finasteride (5 mg) Tablets, manufactured in WHO–GMP certified, strictly dedicated hormonal containment oral solid dosage facilities. This “Dual-Pathway BPH Eradication FDC” is a highly lucrative, massive-volume export to urology centers, geriatric care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, definitive intervention for symptomatic Benign Prostatic Hyperplasia (BPH) and the prevention of disease progression.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) perfectly synchronizes a rapid-acting, uro-selective alpha-blocker with a highly proven, disease-modifying 5-alpha-reductase inhibitor (5-ARI).
The “Symptom Relief & Structural Cure” Specialist:
- Mechanism 1 (The Urethral Relaxer – Tamsulosin 0.4mg): Within days of starting therapy, the Modified-Release Tamsulosin component binds exclusively to alpha-1A receptors in the prostate and bladder neck. This relaxes the smooth muscle, instantly relieving the physical strangulation of the urethra and restoring a strong, painless urinary stream.
- Mechanism 2 (The Prostate Shrinker – Finasteride 5mg): The prostate gland hyper-proliferates when exposed to Dihydrotestosterone (DHT). Finasteride specifically inhibits the Type II 5-alpha-reductase enzyme, blocking the conversion of testosterone to DHT within the prostate itself. Starved of this androgenic fuel, the enlarged prostate gland actively shrinks over several months. This structural reduction drastically lowers the patient’s risk of Acute Urinary Retention (AUR) and the need for invasive transurethral surgery (TURP).
- The FDC Compliance Advantage: Older men suffering from BPH frequently suffer from polypharmacy (taking too many pills). Combining the immediate daytime/nighttime symptom relief of Tamsulosin with the long-term structural cure of Finasteride into a single, once-daily tablet ensures strict patient adherence and far superior long-term clinical outcomes.
Product Composition & Strength
We supply this product as a Precision-Engineered Bilayer Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant and child-resistant Alu-Alu blister strips to ensure the absolute stability of both the kinetic polymer matrix and the sensitive hormonal API.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Tamsulosin Hydrochloride USP/Ph.Eur. | 0.4 mg (Modified-Release) | Continuous 24-hour uro-selective alpha-1A blockade for immediate symptom relief. |
| Finasteride USP/Ph.Eur. | 5 mg | Targeted Type II 5-alpha-reductase inhibition for profound DHT suppression and prostate shrinkage. |
| Excipients | Hypromellose (HPMC) / Microcrystalline Cellulose / Sodium Starch Glycolate / Magnesium Stearate | SR Polymer matrix for Tamsulosin / Diluent for Finasteride (Engineered for strict kinetic segregation) |
*Pack Sizes: 10×10 or 10×15 Alu-Alu Blisters (Optimized specifically for strict 30-day chronic urology adherence regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Urology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Urologicals/Hormonal) |
| CAS Numbers | 106463-17-6 (Tamsulosin) / 98319-26-7 (Finasteride) |
| Dosage Form | Bilayer / Modified-Release (MR) Film-Coated Tablet |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Essential for protecting the hygroscopic MR matrix and the hormonal API from environmental humidity and hydrolytic degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Hormonal Containment & Bilayer Engineering: Finasteride is a potent hormonal teratogen. Our manufacturing is executed within strictly segregated, highly controlled hormonal blocks operating under negative pressure with multi-stage HEPA filtration to guarantee absolute operator safety. Furthermore, our advanced Bilayer Tablet Pressing Technology physically separates the immediate-release Finasteride from the modified-release Tamsulosin polymers, guaranteeing zero cross-reactivity and perfect 24-hour pharmacokinetic profiles.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of severe urological disease in men with an enlarged prostate:
- Benign Prostatic Hyperplasia (BPH): Treatment of moderate-to-severe symptoms of BPH.
- Disease Progression Prevention: Reduction in the risk of acute urinary retention (AUR) and the need for BPH-related surgery (e.g., transurethral resection of the prostate and prostatectomy).
Dosage & Administration
Recommended Dosage (Strictly as per Urologist Guidelines):
- Standard Adult Dosing: One tablet taken orally once daily.
- Administration (THE 30-MINUTE RULE): Should be administered approximately 30 minutes after the same meal each day.
- Swallowing Protocol (CRITICAL HAZARD): The tablet MUST be swallowed whole with a glass of water. It must never be crushed, chewed, or divided. Chewing destroys the modified-release Tamsulosin matrix (risking severe hypotension) and exposes handlers to hormonal toxicity.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX EQUIVALENT (Teratogenicity – Handling Risk): Finasteride prevents the conversion of testosterone to DHT, which is absolutely essential for the development of male genitalia in a fetus. Women who are pregnant or may become pregnant MUST NOT handle crushed, broken, or uncoated tablets. If the active ingredient is absorbed through the skin of a pregnant woman, it will cause catastrophic abnormalities to the external genitalia of a male fetus.
- Prostate-Specific Antigen (PSA) Alteration: Finasteride artificially lowers serum PSA levels by approximately 50% within 6 months of therapy. Urologists must double the tested PSA value in patients taking Finasteride to accurately screen for prostate cancer. Any confirmed increase in PSA while on Finasteride requires immediate oncological evaluation.
- Intraoperative Floppy Iris Syndrome (IFIS): Tamsulosin can cause IFIS during cataract surgery. Patients must inform their ophthalmologist prior to surgery.
- Sexual Dysfunction: The Finasteride component can cause decreased libido, erectile dysfunction, and ejaculation disorders. In rare cases, these symptoms may persist even after the medication is discontinued.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Urological FDCs, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for geriatric care programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in








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