WHO-GMP certified API production with complete DMF support.
Availability: In Stock | CAS: 111974-72-2 | Grade: IP / BP / USP /EP
Surya Life Sciences is a WHO-GMP certified Quetiapine Fumarate API manufacturer and supplier in India, offering high-purity API with complete DMF support for regulated and semi-regulated markets. Quetiapine Fumarate is an atypical antipsychotic used as an active pharmaceutical ingredient in regulated psychiatric and central nervous system (CNS) formulations. It is manufactured for regulated solid oral dosage formulations requiring controlled impurity profiles and consistent assay performance.
As a leading global supplier, Surya Life Sciences serves regulated and semi-regulated pharmaceutical markets with WHO-GMP certified production, scalable capacity, and full regulatory support.
Our manufacturing operations are supported by WHO-GMP–approved facilities and ISO-certified quality systems. Each production batch is manufactured under controlled conditions and released after meeting defined pharmacopeial and regulatory requirements.
Quetiapine Fumarate API Manufacturer in India
As a leading API manufacturer in India, Surya Life Sciences offers cost-effective and regulatory-compliant Quetiapine Fumarate API for global pharmaceutical markets.
Our India-based WHO-GMP certified facilities enable:
- Competitive pricing
- Large-scale production capacity
- Reliable export capabilities
Quetiapine Fumarate API Specifications & Technical Details
| Attribute | Specification |
|---|
| Chemical Name | Quetiapine Fumarate |
| CAS Number | 111974-72-2 |
| Category | Atypical Antipsychotic Agent |
| Therapeutic Use | Treatment of schizophrenia, bipolar disorder, and major depressive disorder |
| Molecular Formula | C₂₁H₂₅N₃O₂S·0.5C₄H₄O₄ |
| Molecular Weight | 505.6 g/mol |
| Appearance | White to off-white powder |
| Solubility | Soluble in dimethylformamide; slightly soluble in water, anhydrous ethanol, and methanol |
| Purity | 99% |
| Shelf Life | 3 years |
| Available Grades | USP/IP/EP/BP |
Why Choose Surya Life Sciences as Your Quetiapine Fumarate API Manufacturer?
At Surya Life Sciences, we focus on batch-to-batch consistency, analytical reliability, and documentation integrity to support psychiatric drug development and commercial manufacturing programs.
Here’s why global leaders choose us:
Regulatory-Ready Documentation & DMF Support
We support Quetiapine Fumarate API programs with documentation suitable for development, registration, and commercial supply, including:
- Drug Master File (DMF) support
- USP/IP/EP/BP compliance data (where applicable)
- Method validation, stability studies, and batch-specific Certificates of Analysis
Reliable Stock Availability & Supply Continuity
Our manufacturing planning and inventory systems are structured to ensure uninterrupted API availability:
- Stock-based and bulk supply options
- Typical dispatch timelines of one week, subject to availability
- Scalable production capacity aligned with commercial demand
Easy Ordering & Reasonable Pricing
Ordering processes support multiple stages of pharmaceutical development:
- Defined MOQs for commercial supply
- Transparent pricing based on batch size and volume
- Clearly confirmed delivery timelines at the order stage
Certified Quality & Compliance
Our API manufacturing operations align with recognised international standards:
- WHO-GMP–approved facilities
- ISO 9001:2000
- ISO 14001:2004
- OHSAS 18001:1999
Global Supplier of Quetiapine Fumarate API
Surya Life Sciences is a reliable global supplier and exporter of Quetiapine Fumarate API, supporting pharmaceutical companies, CDMOs, and generic drug manufacturers worldwide.
We supply:
- Quetiapine API in bulk quantities
- Commercial-scale manufacturing batches
- Export-ready documentation for regulated markets
Our expertise as a Quetiapine API manufacturer ensures consistent quality, regulatory compliance, and scalable production.
Bulk Supply and Customization
We supply Quetiapine Fumarate API in bulk quantities with clearly defined production and delivery timelines to support commercial pharmaceutical manufacturing programs. Our current supply capability supports up to 1,000 kilograms per day, ensuring continuity for large-scale requirements.
Customization Options:
- Batch sizes can be aligned with order volumes and production planning
- Packaging configurations can be customized on request to meet regulatory and logistics requirements
Clinical Uses & Industry Applications of Quetiapine Fumarate API
Quetiapine Fumarate API is used in pharmaceutical formulations for central nervous system (CNS) disorders, including:
Major depressive disorder (as adjunct therapy)
Key industry applications of Quetiapine Fumarate API include:
Psychiatric Finished Dosage Form Manufacturing:
Used by pharmaceutical manufacturers for the production of solid oral dosage forms such as immediate-release and extended-release tablets intended for CNS and psychiatric therapies.
Generic Antipsychotic Drug Development Programs:
Integrated into generic development pipelines supporting abbreviated regulatory submissions, requiring pharmacopeial compliance, validated analytical data, and reproducible batch performance.
Contract API Manufacturing & Long-Term Supply Programs:
Supplied to CDMOs and pharmaceutical partners for contract-based API manufacturing and long-term sourcing arrangements supporting branded and generic antipsychotic formulations. We also manufacture other APIs, including antifungal products such as Fluconazole API, for global pharmaceutical applications.
Storage, Packaging & Handling Information
Storage
Store in a well-closed container, protected from light and moisture.
Packaging
Packed in double polyethylene bags placed inside HDPE drums to maintain stability and prevent contamination.
Handling
Handle in accordance with GMP guidelines and MSDS recommendations using appropriate Personal Protective Equipment (PPE).
Request Batch Details, Pricing, and Availability
Connect with our experts for pricing, availability, technical documentation, regulatory assistance, tailored supply options, and more.
Surya Life Sciences is a trusted Quetiapine Fumarate API manufacturer in India, supporting pharmaceutical companies worldwide with consistent quality, regulatory compliance, and reliable bulk supply.
FAQs
Is your Quetiapine Fumarate API pharmacopeia compliant?
Quetiapine Fumarate API is manufactured to meet USP, IP ,BP and EP standards, with defined specifications for identity, purity, assay, and impurity control.
Do you provide DMF support for Quetiapine Fumarate API?
Yes. Surya Life Sciences supports Drug Master Files (DMFs) and associated regulatory documentation for Quetiapine Fumarate API, subject to regional requirements.
What is the typical delivery time for bulk API orders?
Bulk orders are typically dispatched within one week of order confirmation, subject to batch availability and final quality release.
What is the minimum order quantity (MOQ) for Quetiapine Fumarate API?
The minimum order quantity is 25 kg for smaller requirements; the standard commercial MOQ is 100 kg. API-specific MOQs can be confirmed with our commercial team.
Are you a global exporter of Quetiapine Fumarate API?
Yes, Surya Life Sciences is a global exporter of Quetiapine Fumarate API, supplying to regulated and semi-regulated markets with complete documentation and compliance support.