WHO-GMP certified API production with complete DMF support.
Availability: In Stock | CAS: 89-57-6 | Grade: Pharma Grade
Mesalazine is supplied as a medicine-grade active pharmaceutical ingredient (API). Surya Life Sciences is a leading mesalazine manufacturer in India, providing high-quality API for regulated pharmaceutical applications with defined molecular composition and controlled quality parameters.
Surya Life Sciences Ltd. is a globally trusted mesalazine manufacturer and API supplier, serving regulated and semi-regulated markets worldwide.
Our four WHO-GMP–approved manufacturing facilities, certified to ISO 9001:2015, operate in compliance with applicable quality, safety, and environmental regulations.
Mesalazine API Specifications from a Leading Manufacturer
| Attribute | Specification |
|---|
| Chemical Name | 5-Amino-2-hydroxybenzoic acid |
| CAS | 89-57-6 |
| Category | Aminosalicylate / Anti-inflammatory Agent |
| Therapeutic Use | Treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease |
| Molecular Formula | C₇H₇NO₃ |
| Molecular Weight | 153.14 g/mol |
| Appearance | White crystalline powder |
| Solubility | Slightly soluble in water; soluble in dilute alkali solutions |
| Purity | >99% |
| Storage | Room temperature |
| Shelf Life | |
| Available Grades | IP/BP/USP / EP |
Why Choose Surya Life Sciences as Your Mesalazine Manufacturer?
At Surya Life Sciences, as a trusted mesalazine manufacturer, our Mesalazine API manufacturing is supported by controlled processes, validated analytical methods, and regulatory-aligned quality systems. Our focus is on consistency, documentation integrity, and dependable supply.
Here's why global leaders keep coming back to us:
Regulatory-Ready Documentation & DMF Support
We provide documentation designed to support development, registration, and commercial supply, including:
- Drug Master File (DMF) support
- IP/BP/USP compliance data
- Method validation reports, stability data, and batch-specific Certificates of Analysis
Reliable Stock Availability & Supply Continuity
Our production planning and inventory controls support uninterrupted API supply:
- Stock-based and made-to-order supply options
- Typical dispatch timelines of 7 days, subject to batch availability
- Long-term supply planning for commercial programs
Easy Ordering & Reasonable Pricing
Ordering options are aligned with different stages of pharmaceutical development:
- R&D quantities
- Pilot and validation batches
- Commercial-scale supply at competitive pricing
Certified Quality & Compliance
Our manufacturing operations align with internationally recognised standards:
- WHO-GMP–approved facilities
- ISO 9001:2000
- ISO 14001:2004
- OHSAS 18001:1999
- Compliance with applicable pharmacopeial, environmental, and safety requirements
Bulk Supply and Customization
As a reliable mesalazine manufacturer, Surya Life Sciences supplies Mesalazine API in bulk quantities with defined production and delivery timelines. Current supply capacity is up to 1,000 kilograms per month.
Customization Options:
- Flexible batch sizes based on order quantity and production planning
- Customized packaging formats on request to meet regulatory or logistical requirements
Clinical Uses & Industry Applications of Mesalazine API
Mesalazine API is used in regulated pharmaceutical formulations for inflammatory bowel conditions, including:
Maintenance therapy for gastrointestinal inflammatory disorders
Mild to moderate inflammatory bowel disease
Key industry applications of Mesalazine API include:
Oral Gastrointestinal Dosage Form Manufacturing:
Used in the manufacture of tablets, capsules, and modified-release formulations intended for targeted gastrointestinal delivery under regulated manufacturing environments.
Topical and Rectal Formulations:
Applied in suppositories, enemas, and rectal foam preparations designed for localised anti-inflammatory action in the lower gastrointestinal tract.
Generic Drug Development & ANDA Programs:
Used in generic formulation and registration programs requiring pharmacopeial compliance and batch-to-batch reproducibility.
Contract API Manufacturing & Long-Term Supply:
Supplied to CDMOs and pharmaceutical companies for contract manufacturing, scale-up, and commercial sourcing of Mesalazine API.
Storage, Packaging & Handling Information
Storage
Store at room temperature in a well-closed container.
Packaging
Packed in HDPE drums or cargo boxes with appropriate inner liners.
Handling
Handle in accordance with GMP and MSDS guidelines using appropriate Personal Protective Equipment (PPE).
Request Batch Details, Pricing, and Availability
Connect with our experts for pricing, availability, and regulatory support from a leading mesalazine manufacturer, along with tailored supply options.
FAQs
Is Mesalazine API pharmacopeia compliant?
Mesalazine API is manufactured in compliance with IP, BP, and USP standards, with defined specifications for identity, purity, and quality.
Are DMFs applicable for Mesalazine API?
Yes. Surya Life Sciences supports Drug Master Files (DMFs) and associated regulatory documentation for Mesalazine API, subject to regional requirements.
What is the typical delivery time for bulk Mesalazine API orders?
Mesalazine API orders are typically dispatched within 1 week of confirmation, subject to batch availability and final quality release.
What is the minimum order quantity (MOQ) for Mesalazine API?
The minimum order quantity (MOQ) for Mesalazine API is 100 kg. API-specific MOQs can be reconfirmed with the commercial team. Get in touch to learn more about our mesalazine API supply and services.