Active Pharmaceutical Ingredient

Fulvestrant

Also known as: Faslodex (brand)

CAS: 129453-61-8 Estrogen Receptor Antagonist / Antineoplastic IP / BP / EP / USP Bulk Supply Available
Fulvestrant API Manufacturer India | Mediocon Inc
Fulvestrant — Pharmaceutical Grade API

Product Overview

CAS No: 129453-61-8  |  MF: C₃₂H₄₇F₅O₃S  |  MW: 606.77 g/mol

Fulvestrant is a selective estrogen receptor degrader (SERD) used in the treatment of hormone receptor-positive (HR+) metastatic breast cancer in postmenopausal women. It binds to and degrades the estrogen receptor, blocking estrogen-driven tumor growth.

Mediocon Inc supplies Fulvestrant IP/BP/EP/USP as a high-purity oncology active pharmaceutical ingredient for licensed parenteral formulation manufacturers. With extensive GMP quality controls and multi-pharmacopoeial compliance, our Fulvestrant supports global regulatory submissions.

Key Features

  • Selective estrogen receptor degrader (SERD)
  • No partial agonist activity
  • Multi-pharmacopoeial compliance (IP/BP/EP/USP)
  • Compatible with injectable formulations

Applications

  • HR+ metastatic breast cancer formulations
  • Parenteral oncology injectables
  • Endocrine therapy pharmaceutical manufacturing
  • Oncology clinical research supply

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameFulvestrant
CAS Number129453-61-8
Molecular FormulaC₃₂H₄₇F₅O₃S
Molecular Weight606.77 g/mol
CategoryEstrogen Receptor Antagonist / Antineoplastic
AppearanceWhite to Off-White Powder
GradeIP / BP / EP / USP
Packaging25 kg HDPE Drums / Aluminium Bags
StorageCool, Dry & Ventilated Place

Analytical Specifications

ParameterSpecification
AssayNLT 98.0% & NMT 102.0%
Water ContentNMT 1.0%
Heavy MetalsNMT 10 ppm
Residual SolventsComplies ICH Q3C
Microbial LimitsComplies
IdentificationHPLC & IR Compliant
Specific Rotation+23° to +27°
Packing25 kg HDPE drums / as per requirement
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