Active Pharmaceutical Ingredient (API)

Eszopiclone API Manufacturer & Supplier in India

CAS: 138729-47-2 Active Pharmaceutical Ingredient (API) IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Eszopiclone API Manufacturer & Supplier in India — Mediocon Inc
Eszopiclone API Manufacturer & Supplier in India

Product Overview

CAS No: 138729-47-2 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient (API)

Eszopiclone API Manufacturer & Supplier

Mediocon Inc. is a trusted supplier and exporter of Eszopiclone API, offering high-quality pharmaceutical raw materials for global pharmaceutical manufacturers. Eszopiclone is a non-benzodiazepine hypnotic agent used in sleep disorder formulations and is supplied with consistent quality, high purity, and complete documentation support.

Our Eszopiclone API is manufactured and tested according to stringent quality standards to ensure purity, stability, and compliance with customer-specific requirements. We provide complete technical documents including COA, MSDS, specification sheets, and regulatory support

Product Specifications

Product NameEszopiclone API Manufacturer & Supplier in India
CAS Number138729-47-2
CategoryActive Pharmaceutical Ingredient (API)
GradeIP / BP / EP / USP
AppearanceWhite to off-white crystalline powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationIR & HPLC Complies
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.0%
Heavy MetalsNMT 20 ppm
pH (1% Solution)5.0 – 8.0
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.0%
Water ContentNMT 1.0%
Specific Rotation−5.0° to −8.0° (as per test conditions)
Melting PointApproximately 202–204°C
SolubilitySlightly soluble in water; soluble in methanol and organic solvents

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 Eszopiclone API Manufacturer & Supplier in India (CAS 138729-47-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Eszopiclone API Manufacturer & Supplier in India 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 — Eszopiclone API Manufacturer & Supplier in India

How is Eszopiclone API tested for quality?
Quality testing includes: IR identification HPLC assay Related substance testing Water content analysis Heavy metal testing Residual solvent analysis
What documents are provided with Eszopiclone API?
Mediocon Inc. provides: Certificate of Analysis (COA) MSDS Specification sheet Technical documents
What are the storage conditions for Eszopiclone API?
Store Eszopiclone API in a cool, dry place protected from light and moisture.
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