Active Pharmaceutical Ingredient

Exemestane API Manufacturer & Supplier in India

CAS: 107868-30-4 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Exemestane API Manufacturer & Supplier in India — Mediocon Inc
Exemestane API Manufacturer & Supplier in India

Product Overview

CAS No: 107868-30-4 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Exemestane is a steroidal aromatase inhibitor (AI) primarily used in the treatment of hormone receptor-positive breast cancer in postmenopausal women. It works by irreversibly inhibiting the aromatase enzyme, thereby reducing estrogen production and slowing the growth of estrogen-dependent tumors. Exemestane is widely used in pharmaceutical formulations and oncology therapeutics.

Mediocon Inc. supplies high-purity Exemestane API manufactured under stringent quality control standards for pharmaceutical manufacturing, research, and development applications. Each batch undergoes comprehensive testing to ensure compliance with international quality requirements.

Product Specifications

Product NameExemestane API Manufacturer & Supplier in India
CAS Number107868-30-4
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to off-white crystalline powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationHPLC, IR and UV comply with specification
Assay (HPLC)≥ 99.0%
Loss on DryingNMT 0.5%
Residue on IgnitionNMT 0.1%
Heavy MetalsNMT 10 ppm
pH (1% Solution)Not applicable
Individual ImpurityNMT 0.1%
Total ImpuritiesNMT 0.5%
Water ContentNMT 0.5%
Specific RotationNot Applicable
Melting Point191–193°C
SolubilitySoluble in methanol, ethanol, acetone and chloroform; practically insoluble in water

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 Exemestane API Manufacturer & Supplier in India (CAS 107868-30-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Exemestane 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 — Exemestane API Manufacturer & Supplier in India

How should Exemestane be stored?
Store in a tightly closed container in a cool, dry place, protected from light and moisture to maintain product stability.
Is Exemestane available in bulk quantities?
Yes. Bulk commercial quantities and customized packaging options are available.
Which industries use Exemestane?
Exemestane is primarily used by pharmaceutical manufacturers, oncology drug developers, research organizations, and analytical laboratories
💬
Mediocon AI
Hello 👋 How can I help you today?