Description
Tadalafil & Dapoxetine Tablets
Healthy Inc is a specialized global supplier and exporter of advanced urological, men’s health, and lifestyle therapeutics. We provide ultra-high-purity, kinetically synchronized Tadalafil (10 mg) & Dapoxetine (30 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dual-Action Sexual Dysfunction Synergy” is a highly lucrative, massive-volume export to urology centers, men’s health clinics, retail pharmacy networks, and pharmaceutical distributors in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally demanded, definitive intervention for co-morbid Erectile Dysfunction and Premature Ejaculation.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) perfectly synchronizes the longest-acting PDE5 inhibitor with the only globally approved, short-acting SSRI specifically engineered for on-demand ejaculatory control.
The “ED & PE Eradication” Specialist:
- Mechanism 1 (The Erection Sustainer – Tadalafil 10mg): During sexual stimulation, nitric oxide is released, creating cGMP, which relaxes penile smooth muscle and allows blood to flow in, causing an erection. Normally, the PDE5 enzyme destroys cGMP, causing the loss of the erection. Tadalafil violently blocks the PDE5 enzyme. Known globally as “The Weekend Pill,” its massive 36-hour half-life ensures that patients can achieve and maintain a rigid erection whenever stimulation occurs, eliminating performance anxiety.
- Mechanism 2 (The Ejaculatory Delay – Dapoxetine 30mg): Premature ejaculation is closely linked to central nervous system serotonin levels. Dapoxetine is a unique, ultra-fast-acting Selective Serotonin Reuptake Inhibitor (SSRI). Unlike standard antidepressants that take weeks to work, Dapoxetine floods the synaptic cleft with serotonin within 1 to 3 hours of ingestion, significantly delaying the motor reflex of ejaculation and increasing intravaginal ejaculatory latency time (IELT) by up to 300%.
- The FDC Lifestyle Advantage: ED and PE frequently coexist, creating a devastating psychological loop of performance anxiety. By combining the 36-hour confidence of Tadalafil with the rapid ejaculatory control of Dapoxetine into a single, on-demand pill, patients regain complete control over their sexual function without the burden of taking multiple separate medications.
Product Composition & Strength
We supply this product as a Precision-Engineered Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or Alu-PVC blister strips to ensure the absolute stability of the active pharmaceutical ingredients.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Tadalafil USP/Ph.Eur. | 10 mg | Standard on-demand initiation dose for reliable, long-lasting PDE5 inhibition. |
| Dapoxetine Hydrochloride USP/Ph.Eur. | 30 mg (Equivalent to Dapoxetine base) | Standard on-demand initiation dose for rapid, targeted serotonin reuptake inhibition. |
| Excipients | Microcrystalline Cellulose / Lactose Monohydrate / Croscarmellose Sodium / Magnesium Stearate | Diluent / Superdisintegrant (Engineered for rapid gastric dissolution and strict kinetic absorption) |
*Pack Sizes: 1×4, 10×4, or 10×10 Blisters (Optimized specifically for premium, high-margin retail pharmacy and clinic dispensing).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Men’s Health Clinics, and Wholesale Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Urologicals/Men’s Health) |
| CAS Numbers | 171596-29-5 (Tadalafil) / 129938-20-1 (Dapoxetine HCl) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu or High-Density Alu-PVC Blisters. Ensures strict protection against hydrolytic degradation, guaranteeing a stable, multi-year shelf life 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.
- Synchronized Kinetic Dissolution: Dapoxetine is water-soluble and designed to hit the bloodstream rapidly, while Tadalafil is practically insoluble in water and takes longer to peak. Our facilities utilize advanced high-shear wet granulation and specialized superdisintegrants to ensure that both APIs dissolve flawlessly in the gastric fluid. This guarantees the patient experiences the peak ejaculatory control exactly when the erectile mechanism reaches its maximum therapeutic effect (1 to 3 hours post-ingestion).
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of male sexual dysfunction:
- Co-morbid ED & PE: Treatment of adult men (aged 18 to 64 years) suffering from both Erectile Dysfunction (inability to attain or maintain a sufficient erection) and Premature Ejaculation (intravaginal ejaculatory latency time of less than two minutes).
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing: One tablet (10mg/30mg) taken on-demand, approximately 1 to 3 hours prior to anticipated sexual activity.
- Dosing Frequency (CRITICAL LIMITATION): This is an on-demand medication and MUST NOT be taken more than once every 24 hours. Due to the long half-life of Tadalafil, frequent daily dosing is highly discouraged.
- Administration: Must be swallowed whole with at least one full glass of water. It can be taken with or without food, though heavy, high-fat meals may slightly delay the onset of action. Avoid excessive alcohol consumption, as it massively increases the risk of fainting and severe hypotension.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX EQUIVALENT (Nitrate Contraindication): Tadalafil violently amplifies the hypotensive effects of organic nitrates (like Nitroglycerin or Isosorbide). Co-administration is STRICTLY CONTRAINDICATED and can cause a sudden, fatal drop in blood pressure.
- Serotonin Syndrome (SSRI Contraindication): Dapoxetine is a potent SSRI. It must NEVER be taken concurrently with MAO Inhibitors, other SSRIs/SNRIs, lithium, or St. John’s Wort due to the risk of potentially fatal Serotonin Syndrome. A 14-day washout period is strictly required.
- Orthostatic Hypotension & Syncope: Dapoxetine carries a significant risk of orthostatic hypotension (blood pressure crashing when standing up) and sudden fainting (syncope), especially if taken without enough water or mixed with alcohol.
- Alpha-Blocker Interaction: Co-administration with alpha-blockers (like Tamsulosin) can lead to symptomatic hypotension. Caution is advised.
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 Men’s Health Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Clinic Supplier 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.









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