Active Pharmaceutical Ingredient (API)

Fenfluramine API Manufacturer & Supplier

CAS: 458-24-2 Active Pharmaceutical Ingredient (API) IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Fenfluramine API Manufacturer &  Supplier — Mediocon Inc
Fenfluramine API Manufacturer & Supplier

Product Overview

CAS No: 458-24-2 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient (API)

Fenfluramine is a pharmaceutical active ingredient primarily indicated for the treatment of Dravet syndrome and other severe epileptic disorders. It modulates serotonergic signaling, increasing serotonin release and interacting with multiple serotonin receptors to help reduce seizure frequency. Fenfluramine is manufactured under stringent quality standards to ensure high purity and consistency for pharmaceutical formulations.

Mediocon Inc. supplies high-quality Fenfluramine API for pharmaceutical manufacturing and research applications. Our product is manufactured under GMP-compliant conditions and is supported with complete regulatory documentation, including COA, MSDS, TDS, and export documentation.

Product Specifications

Product NameFenfluramine API Manufacturer & Supplier
CAS Number458-24-2
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)98.5–101.5% (HPLC)
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 20 ppm
pH (1% Solution)4.5 – 6.5
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 2.0%
Water ContentNMT 1.0%
Specific RotationNot Applicable
Melting Point114–118°C
SolubilityFreely soluble in water and methanol; soluble in ethanol

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 Fenfluramine API Manufacturer & Supplier (CAS 458-24-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Fenfluramine API Manufacturer & Supplier 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 — Fenfluramine API Manufacturer & Supplier

What is Fenfluramine?
Fenfluramine is a pharmaceutical active ingredient used primarily in the treatment of Dravet syndrome and certain severe epileptic disorders.
What is the CAS number of Fenfluramine?
The CAS number of Fenfluramine is 458-24-2.
3. What is the appearance of Fenfluramine?
Fenfluramine is supplied as a white to off-white crystalline powder.
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