Flibanserin API Manufacturer & Supplier in India

Flibanserin is a multifunctional serotonin agonist-antagonist used for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. It acts on 5-HT1A and 5-HT2A receptors, restoring the neurotransmitter balance linked to sexual desire.

Mediocon Inc manufactures Flibanserin IP/BP/USP as a high-purity active pharmaceutical ingredient for licensed pharmaceutical manufacturers worldwide. Our GMP-certified facility ensures strict quality standards, full batch documentation, and reliable bulk supply for domestic and export clients.

Key Features

• Acts on 5-HT1A agonist & 5-HT2A antagonist
• High purity pharmaceutical grade
• Full regulatory documentation available
• Available for bulk export orders

Applications

• HSDD (Hypoactive Sexual Desire Disorder) formulations
• CNS therapeutic formulations
• Women's health pharmaceutical products
• Neuropsychiatric clinical 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

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Flibanserin (CAS 167933-07-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Flibanserin 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