Active Pharmaceutical Ingredient

Fluoxetine

Also known as: Prozac (brand)

CAS: 54910-89-3 Antidepressant / SSRI IP / BP / USP Bulk Supply Available
Fluoxetine API Manufacturer India | Mediocon Inc
Fluoxetine — Pharmaceutical Grade API

Product Overview

CAS No: 54910-89-3  |  MF: C₁₇H₁₈F₃NO  |  MW: 309.33 g/mol

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of major depressive disorder, OCD, bulimia nervosa, panic disorder, and premenstrual dysphoric disorder. It increases serotonin levels in the synaptic cleft by blocking its reabsorption.

Mediocon Inc manufactures Fluoxetine IP/BP/USP as a high-purity active pharmaceutical ingredient for psychiatric and CNS formulation manufacturers worldwide. Our GMP-compliant manufacturing and rigorous quality assurance ensure each batch meets full pharmacopoeial specifications.

Key Features

  • Selective serotonin reuptake inhibitor (SSRI)
  • Long half-life for once-daily dosing
  • High bioavailability oral formulation
  • Meets IP/BP/USP pharmacopoeial standards

Applications

  • Major depressive disorder (MDD) formulations
  • OCD & anxiety disorder products
  • Bulimia nervosa pharmaceutical therapy
  • Psychiatric & CNS pharmaceutical manufacturing

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 NameFluoxetine
CAS Number54910-89-3
Molecular FormulaC₁₇H₁₈F₃NO
Molecular Weight309.33 g/mol
CategoryAntidepressant / SSRI
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / USP
Packaging25 kg HDPE Drums / Aluminium Bags
StorageCool, Dry & Ventilated Place

Analytical Specifications

ParameterSpecification
AssayNLT 99.0% (as HCl salt)
Water ContentNMT 0.5%
Heavy MetalsNMT 10 ppm
Residual SolventsComplies ICH Q3C
Microbial LimitsComplies
IdentificationHPLC & IR Compliant
Melting Point158 – 163 °C
Packing25 kg HDPE drums / as per requirement
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