Description

Tadalafil Tablets (2.5mg – 20mg)

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 Tadalafil Tablets in India. Widely known as “The Weekend Pill,” Tadalafil is a potent Phosphodiesterase Type 5 (PDE5) inhibitor used for the treatment of Erectile Dysfunction (ED) and the signs and symptoms of Benign Prostatic Hyperplasia (BPH).

We offer Contract Manufacturing (Third Party) services for this high-volume lifestyle drug. Unlike Sildenafil, which works for 4-6 hours, Tadalafil remains active for up to 36 hours, offering patients greater spontaneity. Our WHO-GMP certified facility in Mumbai utilizes advanced solubility-enhancement technologies to ensure rapid onset of action. Healthy Inc manages the export logistics, supplying pharmacy chains and men’s health clinics across the USA, Europe, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Formulating Tadalafil requires overcoming poor water solubility.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Tadalafil is practically insoluble in water (BCS Class II). We use Micronized API (particle size < 10 microns) to drastically increase the surface area, ensuring the drug dissolves and absorbs rapidly in the body.

  • Granulation: We employ wet granulation with specific surfactants (like SLS) to further aid wetting and dissolution.

  • Film Coating: We use premium Opadry II systems to give the tablet its characteristic yellow/orange color, smooth finish, and taste masking properties.

• The Exporter: Healthy Inc

  • Discreet Packaging: We offer customized packaging solutions, including discreet blister packs and wallets, which are highly requested in the men’s health sector.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within the specified timeframe, validating the bioavailability.

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

• Related Substances: We monitor for impurities to ensure safety over the 3-year shelf life.

5. Why Use Tadalafil?

It offers flexibility and dual benefits.

• Mechanism: It blocks the PDE5 enzyme in the smooth muscle cells of the penis and prostate. This prevents the breakdown of cGMP, leading to prolonged relaxation of blood vessels and increased blood flow.

• Key Indications:

  • Erectile Dysfunction (ED): inability to achieve or maintain an erection.

  • BPH (Enlarged Prostate): The 5mg daily dose relaxes muscles in the prostate and bladder, relieving urinary symptoms like weak stream or frequent urination.

  • Pulmonary Arterial Hypertension (PAH): (Specifically the 20mg or 40mg dose) Relaxes blood vessels in the lungs.

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 Tadalafil Tablets?

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

• Q: Is Tadalafil better than Sildenafil (Viagra)?

  A: Tadalafil lasts longer (36 hours vs. 4 hours) and its absorption is not affecting by food. This makes it preferred for spontaneity.

• Q: Can I take 20mg every day?

  A: No. The 10mg and 20mg doses are for “On-Demand” use (before activity). For daily use, the lower 2.5mg or 5mg dose is prescribed.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• On-Demand: 10mg or 20mg taken at least 30 minutes before anticipated sexual activity. Maximum one dose in 24 hours.

• Daily Use: 2.5mg or 5mg taken at the same time every day.

• Administration: Swallow whole with water. Can be taken with or without food.

9. Side Effects and Precautions

• Common Side Effects: Headache, dyspepsia (indigestion), back pain, myalgia (muscle pain), and flushing.

• Contraindications: DO NOT USE with Nitrates (like Nitroglycerin for chest pain). The combination can cause a fatal drop in blood pressure.

• Priapism: Rare risk of erection lasting >4 hours. Seek immediate medical help.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep in the original package to protect from moisture.