Quetiapine Fumarate API is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in the formulation of atypical antipsychotic medications. Quetiapine Fumarate is a second-generation antipsychotic (SGA) indicated for the treatment of schizophrenia, bipolar disorder, major depressive disorder (as adjunct therapy), and other psychiatric disorders. It acts by modulating dopamine (D₂) and serotonin (5-HT₂A) receptors, providing effective management of psychotic and mood disorders. Its superior purity, excellent stability, and consistent batch-to-batch quality make it ideal for pharmaceutical formulation development, analytical testing, quality control, stability studies, and authorized pharmaceutical research.
MEDIOCON INC is a trusted Quetiapine Fumarate API manufacturer and bulk supplier in India, supplying premium-quality pharmaceutical ingredients to pharmaceutical companies, biotechnology organizations, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and international distributors. Our GMP-compliant manufacturing facilities employ advanced production technologies and stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.
Every batch of Quetiapine Fumarate API manufactured by MEDIOCON INC undergoes comprehensive analytical testing using validated quality control methods. Critical quality parameters including identity, assay, impurity profile, moisture content, pH, melting point, specific rotation, residual solvents, particle size distribution, heavy metals, and stability are carefully evaluated before commercial release to ensure compliance with stringent pharmaceutical quality specifications.
Our Quetiapine Fumarate API is available in USP, EP, BP, IP, and Pharmaceutical Grade, making it suitable for immediate-release and extended-release tablet formulations, analytical testing, formulation development, quality control laboratories, stability studies, pharmaceutical process validation, and authorized pharmaceutical research. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting regulatory documents, ensuring seamless procurement and regulatory compliance.
With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a dependable global supplier of pharmaceutical raw materials. Through secure packaging, competitive pricing, efficient logistics, and dedicated technical support, we ensure reliable worldwide delivery of premium-quality Quetiapine Fumarate API.
If you are looking for a reliable Quetiapine Fumarate API manufacturer, exporter, and bulk supplier, MEDIOCON INC offers pharmaceutical-grade ingredients backed by complete documentation, consistent quality, and timely worldwide supply.
| Parameter | Specification |
|---|---|
| Appearance | White to Off-White Crystalline Powder |
| Identification | IR, HPLC & UV Complies |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Specific Rotation | Not Applicable (Achiral Compound) |
| Melting Point | 172°C – 176°C |
| Solubility | Freely Soluble in Water and Methanol; Slightly Soluble in Ethanol |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Quetiapine Fumarate API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 111974-69-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Quetiapine Fumarate API Manufacturer & Bulk Supplier in India | MEDIOCON INC 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.
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