Active Pharmaceutical Ingredient

Loteprednol Etabonate API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 82034-46-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Loteprednol Etabonate API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Loteprednol Etabonate API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 82034-46-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Loteprednol Etabonate API Manufacturer & Supplier in India

Loteprednol Etabonate is a synthetic corticosteroid and topical anti-inflammatory active pharmaceutical ingredient. It is primarily used in ophthalmic formulations for the treatment of steroid-responsive inflammatory conditions of the eye.

Loteprednol Etabonate has CAS Number 82034-46-6, molecular formula C₂₄H₃₁ClO₇, and molecular weight approximately 466.95 g/mol.

MEDIOCON INC supplies Loteprednol Etabonate subject to product availability, applicable specifications, documentation and regulatory requirements.

Key Applications

  • Ophthalmic formulation development
  • Corticosteroid formulations
  • Anti-inflammatory pharmaceutical development
  • Ophthalmic research
  • Pharmaceutical formulation research
  • Analytical applications
  • Bulk API requirements

Product Information

CAS Number: 82034-46-6
Molecular Formula: C₂₄H₃₁ClO₇
Molecular Weight: 466.95 g/mol
Chemical Class: Corticosteroid ester
Pharmacological Class: Corticosteroid / anti-inflammatory

Product Specifications

Product NameLoteprednol Etabonate API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number82034-46-6
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white crystalline powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
Assay (HPLC)98.0–102.0%
Loss on DryingNMT 0.5%
Residue on IgnitionNMT 0.1%
Heavy MetalsNMT 10 ppm
Individual ImpurityNMT 0.2%
Total ImpuritiesNMT 0.5%
Melting Point220–233°C

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 Loteprednol Etabonate API Manufacturer & Supplier in India | MEDIOCON INC (CAS 82034-46-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Loteprednol Etabonate 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 — Loteprednol Etabonate API Manufacturer & Supplier in India | MEDIOCON INC

What is Loteprednol Etabonate API?
Loteprednol Etabonate is a corticosteroid anti-inflammatory API primarily used in ophthalmic formulations.
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