Description

Dutasteride Soft Gelatin Capsules

Healthy Inc is a specialized global supplier and exporter of advanced urological and geriatric therapeutics. We provide high-purity Dutasteride Soft Gelatin Capsules (0.5 mg), manufactured in WHO–GMP certified dedicated softgel facilities. This “Dual 5-Alpha Reductase Inhibitor” is a mandatory, high-volume export to urology centers, geriatric care hospitals, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a definitive, disease-modifying intervention for Symptomatic Benign Prostatic Hyperplasia (BPH).

Product Overview

This formulation contains Dutasteride, a highly potent, synthetic 4-azasteroid compound.

The “Prostate Shrinking” Specialist:

• Mechanism (Dual Enzyme Blockade): Unlike finasteride (which only inhibits Type II), Dutasteride is a dual inhibitor that completely blocks both Type I and Type II 5-alpha-reductase isoenzymes. These enzymes are responsible for converting testosterone into dihydrotestosterone (DHT), the primary androgen that drives prostate growth.
• Disease Modification: By suppressing serum and intraprostatic DHT levels by over 90%, Dutasteride doesn’t just treat the symptoms—it physically shrinks the enlarged prostate gland over time. This drastically improves urinary flow rates and relieves severe lower urinary tract symptoms (LUTS).
• Surgical Prevention: It is clinically proven to significantly reduce the risk of Acute Urinary Retention (AUR) and the subsequent need for invasive BPH-related surgeries (like TURP).

Product Composition & Strength

We supply this product as an Opaque Soft Gelatin Capsule containing Dutasteride dissolved in a specialized lipid/liquid matrix, packed in secure blister strips.

*Pack Sizes: 10×10 Alu-Alu Blisters or Alu-PVC Blisters. (Alu-Alu is highly recommended to protect the softgel shell in extreme tropical humidity).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified softgel units.

• Advanced Softgel Technology: Dutasteride is practically insoluble in water. Our specialized liquid-filling encapsulation lines suspend the API in a highly calibrated lipid matrix, ensuring rapid, uniform absorption in the gastrointestinal tract that hard tablets cannot achieve.
• High-Containment Processing: Because Dutasteride is highly potent and teratogenic, our manufacturing suites utilize stringent negative-pressure containment and specialized HVAC filtration to protect operators from aerosolized exposure during the lipid-mixing phase.

Therapeutic Indications (Human Use)

Indicated for the management of urological and prostatic conditions:

• Benign Prostatic Hyperplasia (BPH): Treatment of symptomatic BPH in men with an enlarged prostate to improve symptoms and reduce prostate size.
• Risk Reduction: To reduce the risk of acute urinary retention (AUR) and the need for BPH-related surgery.
• Combination Therapy: Often prescribed in combination with an alpha-blocker (like Tamsulosin) for the immediate and long-term treatment of moderate to severe BPH.

Dosage & Administration

Recommended Dosage (Strictly as per Urologist/Physician):

• Administration: 0.5 mg taken orally once daily, with or without food.
• Swallowing Protocol (CRITICAL): The capsule MUST be swallowed whole. It must not be chewed or opened. The active ingredient can cause severe localized irritation to the oropharyngeal mucosa if released in the mouth.
• Therapeutic Lag: While early symptom improvement may be seen, patients must be counseled that it can take up to 6 months of daily therapy to achieve the maximum clinical prostate shrinkage and symptom relief.

Safety Warnings (CRITICAL):

• Teratogenic Hazard (Handling Warning): ABSOLUTE CONTRAINDICATION IN WOMEN. Dutasteride is heavily teratogenic. Women who are pregnant, or may become pregnant, MUST NOT handle crushed, leaking, or broken capsules. The active ingredient can be absorbed through the skin and cause severe abnormalities in the genitalia of a male fetus.
• Blood Donation Restriction: Men taking Dutasteride must not donate blood until at least 6 months have passed following their last dose, to prevent pregnant women from receiving Dutasteride-tainted blood.
• PSA Monitoring: Dutasteride reduces serum Prostate-Specific Antigen (PSA) levels by approximately 50% within 3 to 6 months. To accurately screen for prostate cancer in men taking this drug, the clinician must double the patient’s measured PSA value for comparison to normal ranges.

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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Urological and Softgel Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement 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.