Active Pharmaceutical Ingredient

Levothyroxine Sodium API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 55-03-8 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Levothyroxine Sodium API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Levothyroxine Sodium API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 55-03-8 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Levothyroxine Sodium API is the sodium salt of levothyroxine, the synthetic levoisomer of thyroxine (T4), a naturally occurring thyroid hormone. It is a highly potent thyroid hormone pharmaceutical ingredient used as thyroid hormone replacement therapy, particularly in the management of hypothyroidism. Levothyroxine is converted in peripheral tissues to the more biologically active thyroid hormone triiodothyronine (T3), which participates in the regulation of cellular metabolism, growth, development and thermogenesis.

Chemically, Levothyroxine Sodium is the sodium salt of L-thyroxine and contains four iodine atoms within its molecular structure. The anhydrous sodium salt has the molecular formula C₁₅H₁₀I₄NNaO₄, molecular weight approximately 798.85 g/mol, and CAS number 55-03-8.

Levothyroxine Sodium is an iodinated amino-acid derivative and is structurally related to endogenous thyroid hormone T4. Because of its very high potency and the importance of precise dose delivery, control of identity, potency, related substances, water/hydration state and other critical quality attributes is particularly important during pharmaceutical manufacturing and quality control.

The exact solid form is important for specification purposes. PubChem separately identifies Levothyroxine Sodium anhydrous, Levothyroxine Sodium monohydrate, and other hydrated forms. For example, the monohydrate is listed with molecular formula C₁₅H₁₂I₄NNaO₅ and molecular weight 816.87 g/mol.

MEDIOCON INC supplies Levothyroxine Sodium for applicable pharmaceutical manufacturing, formulation development, analytical research, quality-control applications and bulk API requirements, subject to applicable regulatory requirements and batch-specific documentation.

Key Applications

  • Thyroid hormone replacement formulations
  • Hypothyroidism formulations
  • Pharmaceutical formulation development
  • Oral pharmaceutical preparations
  • Analytical research
  • Quality-control testing
  • Pharmaceutical manufacturing
  • Bulk API sourcing

Product Specifications

Product NameLevothyroxine Sodium API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number55-03-8
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
StandardsUSP / EP / applicable pharmacopoeial standard

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Levothyroxine Sodium API Manufacturer & Supplier in India | MEDIOCON INC (CAS 55-03-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Levothyroxine Sodium API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Levothyroxine Sodium API Manufacturer & Supplier in India | MEDIOCON INC

What is Levothyroxine Sodium?
Levothyroxine Sodium is the sodium salt of levothyroxine (L-thyroxine/T4) and is used as thyroid hormone replacement therapy.
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