Description

Sildenafil Citrate Tablets (20mg – 100mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Sildenafil Citrate Tablets in India. Globally recognized as the “Blue Pill,” Sildenafil is the first-line oral therapy for the treatment of Erectile Dysfunction (ED). It is a potent Phosphodiesterase Type 5 (PDE5) inhibitor that restores impaired erectile function by increasing blood flow to the penis during sexual stimulation.

We offer Contract Manufacturing (Third Party) services for this high-demand lifestyle drug. Additionally, we manufacture the 20mg strength indicated for Pulmonary Arterial Hypertension (PAH). Our WHO-GMP certified facility in Mumbai utilizes advanced micronization and coating technologies to ensure rapid dissolution and onset of action. Healthy Inc manages the export logistics, supplying pharmacy chains, men’s health clinics, and government tenders across Latin America, Southeast Asia, Africa, and CIS countries.

2. Product Specifications

3. Manufacturing Technology

Ensuring rapid onset is the critical performance metric.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Sildenafil Citrate has poor water solubility. We use Micronized API (reduced particle size) to drastically increase the surface area. This ensures the drug dissolves rapidly in the stomach, allowing for an onset of action within 30–60 minutes.

  • Taste Masking: The pure drug has a bitter taste. We use a premium Opadry Blue Film Coating to provide the iconic appearance, mask the taste, and ensure smooth swallowing.

  • Hardness Control: Tablets are compressed to a precise hardness that prevents crumbling during shipping but allows for rapid disintegration (< 10 minutes) upon ingestion.

• The Exporter: Healthy Inc

  • Custom Packaging: We provide varied packaging formats, including “Pocket Packs” (1 or 4 tablets) for the lifestyle market and bulk packs for hospital use (PAH indication).

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes, guaranteeing consistent performance.

• Assay: We use HPLC to confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for related substances (Impurities A, B, etc.) to ensure safety over the 3-year shelf life.

5. Why Use Sildenafil?

It is the most established and studied treatment for ED.

• Mechanism: It selectively inhibits the PDE5 enzyme, which degrades cGMP in the corpus cavernosum. By preventing this breakdown, Sildenafil amplifies the effect of Nitric Oxide (NO) released during sexual stimulation, relaxing smooth muscles and allowing blood inflow to produce an erection.

• Key Indications:

  • Erectile Dysfunction (ED): Inability to achieve or maintain an erection sufficient for sexual performance.

  • Pulmonary Arterial Hypertension (PAH): (20mg dose) Relaxes blood vessels in the lungs to reduce pulmonary blood pressure and improve exercise capacity.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Sildenafil Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: How long does it take to work?

  A: It typically takes 30 to 60 minutes to work. It is most effective when taken on an empty stomach; a high-fat meal can delay absorption.

• Q: Is it safe for heart patients?

  A: Caution is required. It is absolutely CONTRAINDICATED in patients taking Nitrates (for chest pain). For other heart conditions, a doctor’s consultation is mandatory.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• ED Dosage: 50mg taken approximately 1 hour before sexual activity. Dose may be increased to 100mg or decreased to 25mg based on efficacy and tolerability. Max frequency: Once daily.

• PAH Dosage: 20mg three times daily (TID).

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• Common Side Effects: Headache, flushing, dyspepsia (indigestion), nasal congestion, and visual disturbances (blue tinge to vision).

• Contraindications: Use with Nitrates (Nitroglycerin, Isosorbide) can cause fatal hypotension. Do not use in patients with severe liver/kidney impairment or recent stroke/heart attack.

• Priapism: Seek medical help if an erection lasts longer than 4 hours.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from moisture.