Description

Thyroxine Sodium Tablets (12.5mcg to 200mcg)

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 Thyroxine Sodium (Levothyroxine) Tablets in India. This is a Narrow Therapeutic Index (NTI) drug used for the lifelong management of Hypothyroidism (underactive thyroid). Because the dosage is in micrograms (mcg), precision manufacturing is critical to ensure patient safety and hormonal balance.

We offer Contract Manufacturing (Third Party) for a wide range of strengths, allowing for precise titration. Our WHO-GMP certified facility in Mumbai utilizes advanced blending technologies to ensure perfect Content Uniformity in every tablet. Healthy Inc manages the export logistics, supplying this essential medicine to government health programs, hospitals, and pharmacies across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Thyroxine Sodium Tablets

Manufacturing microgram-dose hormones requires exceptional precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  Thyroxine is potent in extremely small quantities (100mcg is just 0.1mg). We use Geometric Mixing and High-Shear Granulation to ensure the active ingredient is evenly distributed throughout the excipients. If not mixed perfectly, one tablet could have too much hormone (causing palpitations) and the next too little. We manufacture under Light-Protected Conditions because Thyroxine is sensitive to light and moisture.

• The Exporter: Healthy Inc

  Healthy Inc ensures stability during transit. Thyroxine is known to degrade if exposed to heat or light. We use Amber HDPE Bottles with desiccants or Alu-Alu Cold Form Blisters to provide a total barrier against light and humidity. We ensure cold-chain or temperature-controlled shipping where necessary for specific markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards for NTI drugs:

• Content Uniformity: We perform extensive sampling (USP <905>) to ensure every single tablet contains the exact claimed dose.

• Dissolution: We test for rapid dissolution to ensure bioequivalence to innovator brands.

• Stability: We conduct long-term and accelerated stability studies to guarantee potency over the 2-year shelf life.

5. Why Use Thyroxine Sodium?

It is the standard replacement therapy for a missing or underactive thyroid.

• Mechanism: It is a synthetic version of the natural hormone Thyroxine (T4). Once ingested, the body converts it into the active form (T3), which regulates metabolism, heart rate, and temperature.

• Key Indications:

  • Hypothyroidism: Replacement therapy for patients with low thyroid hormone.

  • Goiter: To shrink enlarged thyroid glands (euthyroid goiter).

  • Thyroid Cancer: Used to suppress TSH levels in patients with thyroid cancer.

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 Thyroxine Sodium Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India with micro-dosing expertise.

• Q: Why are there so many different strengths?

  A: Thyroid replacement requires precise “titration.” A patient might need exactly 88mcg, and taking a 100mcg tablet would cause side effects.

• Q: Can I switch brands easily?

  A: Because it is a Narrow Therapeutic Index drug, small differences in absorption can matter. It is best to stick to one manufacturer or monitor TSH levels after switching.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Timing: Must be taken on an empty stomach, at least 30-60 minutes before breakfast, with a full glass of water.

• Food Interactions: Absorption is reduced by food, especially soybean flour, cotton seed meal, walnuts, and dietary fiber.

• Dosage: Individualized based on TSH levels.

9. Side Effects and Precautions

• Overdose (Hyperthyroidism): Palpitations, rapid heart rate, weight loss, nervousness, and sweating.

• Underdose: Fatigue, weight gain, and cold intolerance.

• Cardiac Patients: Start with a lower dose in elderly patients or those with heart disease to avoid angina.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture. Keep the bottle tightly closed.