Description

Levothyroxine Sodium Tablets (25mcg 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 Levothyroxine Sodium Tablets in India. Levothyroxine (T4) is the Gold Standard Hormone Replacement Therapy for the treatment of Hypothyroidism (underactive thyroid). It is chemically identical to the natural thyroxine hormone produced by the human thyroid gland.

We offer Contract Manufacturing (Third Party) services for this Narrow Therapeutic Index (NTI) drug. Manufacturing Levothyroxine requires extreme precision because small variations in dose can cause significant clinical issues. Our WHO-GMP certified facility in Mumbai utilizes advanced Low-Shear Blending and automated weight control systems to ensure that every tablet contains the exact microgram dose labeled. Healthy Inc manages the export logistics, supplying endocrinology centers and pharmacy chains across the USA, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Microgram precision is the only standard.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: Levothyroxine is potent in micrograms (1/1000th of a milligram). We use Geometric Dilution and validated mixing protocols to ensure the active ingredient is perfectly distributed. A variance of even a few micrograms can alter a patient’s TSH levels.

  • Stability Enhancement: The molecule is sensitive to light, heat, and moisture. We process it in controlled environments and use specific stabilizers (like Mannitol or specialized starch grades) to prevent potency loss over time.

  • Color Coding: We manufacture tablets in distinct colors (compliant with FDA/Global standards) for each strength to prevent medication errors, as patients often switch doses.

• The Exporter: Healthy Inc

  • Desiccant Protection: We use HDPE bottles with integrated desiccants or high-barrier Alu-Alu blisters to protect the drug from humidity during shipping, which is the #1 cause of potency loss in Levothyroxine.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure consistent bioavailability. USP requires very specific dissolution limits for Levothyroxine to ensure it is bioequivalent to the innovator.

• Assay: We confirm the potency is strictly within 95-105% of the label claim (tighter limits than standard drugs).

• Impurity Profiling: We strictly monitor for degradation products (Liothyronine, etc.) to ensure safety.

5. Why Use Levothyroxine?

It restores the body’s metabolic rhythm.

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

• Key Indications:

  • Hypothyroidism: Replacement therapy for patients with low thyroid function (Hashimoto’s, surgical removal).

  • Pituitary TSH Suppression: Used to treat or prevent certain types of euthyroid goiters or thyroid cancer.

• Advantage: Its long half-life (7 days) allows for convenient Once-Daily Dosing.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Data) 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 Levothyroxine Tablets?

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

• Q: Is it Synthroid/Eltroxin?

  A: Synthroid and Eltroxin are brand names. We manufacture the Generic Equivalent (Levothyroxine Sodium). Note: Due to the Narrow Therapeutic Index, patients should consult their doctor before switching brands.

• Q: When should I take it?

  A: It MUST be taken on an empty stomach, at least 30-60 minutes before breakfast, with a full glass of water. Food, calcium, and iron supplements block its absorption.

• Q: Does it cause weight loss?

  A: It helps restore normal weight if you were hypothyroid. It should NEVER be used as a diet pill for people with normal thyroid function (it is dangerous and ineffective).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 1.6 mcg/kg/day (typically start 50-100mcg).

• Elderly/Cardiac Patients: Start low (12.5-25mcg) and titrate slowly.

• Administration: Single daily dose in the morning on an empty stomach.

9. Side Effects and Precautions

• Hyperthyroidism (Overdose): Palpitations, rapid heart rate, weight loss, heat intolerance, tremors, anxiety. (Check TSH levels).

• Cardiac: Use caution in patients with angina or heart disease (can precipitate a heart attack).

• Bone Density: Long-term over-treatment can reduce bone mineral density (Osteoporosis risk).

• Interactions: Iron, Calcium, Antacids, and Soy decrease absorption. Separate by 4 hours.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture. (Crucial for stability).