Active Pharmaceutical Ingredient

Toremifene Citrate (CAS 89778-27-8) API Manufacturer & Supplier in India

Also known as: Fareston Citrate; FC-1157a citrate

CAS: 89778-27-8SERMIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Toremifene Citrate API — Mediocon Inc
Toremifene Citrate — Selective Estrogen Receptor Modulator API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 89778-27-8  |  MF: C₂₆H₂₈ClNO·C₆H₈O₇  |  MW: 598.08 g/mol

Toremifene Citrate is a high-purity Selective Estrogen Receptor Modulator (SERM) supplied by Mediocon Inc as an Active Pharmaceutical Ingredient (API) conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India, it meets the stringent quality requirements of global pharmaceutical manufacturers.

Toremifene Citrate is the citrate salt form of Toremifene, offering enhanced bioavailability and formulation stability for the treatment of hormone-sensitive breast cancer in postmenopausal women.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Breast cancer (estrogen receptor-positive)
  • Post-menopausal hormonal therapy
  • SERM-based oncology formulations
  • Hormonal receptor modulation research

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 NameToremifene Citrate
Also Known AsFareston Citrate; FC-1157a citrate
CAS Number89778-27-8
Molecular FormulaC₂₆H₂₈ClNO·C₆H₈O₇
Molecular Weight598.08 g/mol
CategorySelective Estrogen Receptor Modulator (SERM)
AppearanceWhite to off-white crystalline powder
SolubilitySoluble in methanol and ethanol; slightly soluble in water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.TOR/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

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 Toremifene Citrate (CAS 89778-27-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Toremifene Citrate 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 — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — 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
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Toremifene Citrate API

What is the minimum order quantity for Toremifene Citrate API?
Mediocon Inc supplies Toremifene Citrate with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Toremifene Citrate does Mediocon supply?
We supply Toremifene Citrate conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Toremifene Citrate API?
Every shipment of Toremifene Citrate comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Toremifene Citrate bulk orders?
Standard lead time for Toremifene Citrate is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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