Description

Sildenafil Citrate Capsules

Healthy Inc is a specialized global supplier and exporter of advanced urological and men’s health therapeutics. We provide high-purity Sildenafil Citrate Capsules (50 mg / 100 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “PDE5 Inhibitor” is a massive-volume, high-margin export to urology clinics, men’s health centers, and pharmacy distributors in Africa, LATAM, and Southeast Asia, serving as the globally recognized, frontline pharmacological intervention for Erectile Dysfunction (ED) and off-label management of Pulmonary Arterial Hypertension (PAH).

Product Overview

This formulation contains Sildenafil (as Sildenafil Citrate), a highly potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5).

The “Vasodilatory” Specialist:

• Mechanism (PDE5 Blockade): The physiological mechanism of an erection involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO activates the enzyme guanylate cyclase, resulting in increased levels of cyclic guanosine monophosphate (cGMP). cGMP produces smooth muscle relaxation and a massive inflow of blood. Sildenafil significantly enhances the effect of NO by inhibiting PDE5, the enzyme normally responsible for degrading cGMP.
• The Capsule Advantage (Rapid Onset): While standard Sildenafil is manufactured as a hard, densely compressed tablet, the Hard Gelatin Capsule formulation offers a distinctly faster disintegration profile in the acidic gastric environment. This rapid dissolution releases the uncompressed API powder instantly, leading to a highly reliable and marginally faster onset of clinical action—a critical selling point for on-demand therapeutics.
• Requirement of Stimulation: Sildenafil has no direct relaxant effect on isolated human corpus cavernosum. It strictly requires the natural release of NO (via sexual stimulation) to be clinically effective.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in specialized small-count blister strips standard to the men’s health industry.

*Pack Sizes: 1×4, 2×4, or 10×4 Alu-PVC Blisters. (The 4-capsule strip is the undisputed global standard for retail ED dispensing).

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 units.

• Dissolution Optimization: The API is micronized and blended with premium superdisintegrants prior to encapsulation. This ensures the gelatin shell ruptures within 3 to 5 minutes of entering the stomach, facilitating a rapid peak plasma concentration ($C_{max}$) typically within 30 to 120 minutes.
• Strict Impurity Profiling: Sildenafil synthesis can yield numerous related substances. Our API undergoes exhaustive High-Performance Liquid Chromatography (HPLC) screening to ensure all toxic impurities remain well below strict pharmacopeial limits, guaranteeing cardiovascular safety.

Therapeutic Indications (Human Use)

Indicated for the management of urological and vascular conditions:

• Erectile Dysfunction (ED): Treatment of impotence/erectile dysfunction in adult men, allowing for a sustained erection satisfactory for sexual activity.
• Pulmonary Arterial Hypertension (PAH): Off-label, high-dose utilization to relax the pulmonary blood vessels, reducing the workload on the right ventricle of the heart.

Dosage & Administration

Recommended Dosage (Strictly as per Physician/Urologist):

• Administration (Timing): Taken orally as needed, approximately 1 hour before sexual activity. However, it may be taken anywhere from 30 minutes to 4 hours before activity.
• Dietary Restriction: Taking Sildenafil Capsules with a high-fat meal significantly delays the rate of absorption, reducing the peak concentration and delaying the onset of action by over an hour. It is optimally taken on an empty stomach.
• Standard Dose: 50 mg. Based on effectiveness and tolerance, the dose may be increased to a maximum recommended dose of 100 mg, or decreased to 25 mg.
• Frequency: The maximum recommended dosing frequency is once per day.

Safety Warnings (CRITICAL):

• Nitrate Contraindication (FATAL HYPOTENSION): Sildenafil drastically amplifies the hypotensive effects of nitrates. It is ABSOLUTELY CONTRAINDICATED in patients using organic nitrates in any form (e.g., Nitroglycerin, Isosorbide Dinitrate), either regularly or intermittently.
• Alpha-Blocker Interaction: Co-administration with alpha-blockers (like Tamsulosin, used for BPH) can lead to symptomatic hypotension and fainting. Patients should be hemodynamically stable on alpha-blocker therapy prior to initiating Sildenafil.
• Priapism Risk: Erections lasting longer than 4 hours are a medical emergency. If left untreated, priapism will result in severe, permanent damage to the penile tissue and irreversible loss of potency.
• Ocular & Otic Toxicity: Sudden loss of vision in one or both eyes (Non-Arteritic Anterior Ischemic Optic Neuropathy – NAION) or sudden decrease/loss of hearing has been rarely reported. Therapy must be stopped immediately if this occurs.

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 Men’s Health Medicines, 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.