Fluoxetine API Manufacturer & Supplier in India

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

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Fluoxetine (CAS 54910-89-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Fluoxetine 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