Mesalamine / Mesalazine Manufacturer & Exporter
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Premium Quality Mesalamine / Mesalazine
Mesalamine is an anti-inflammatory drug used in the treatment of ulcerative colitis and Crohn’s disease. Manufactured under WHO-GMP guidelines, D.K. Pharmachem supplies Mesalamine with consistent purity and strong regulatory support.
Its therapeutic value in managing inflammatory bowel disease makes it a critical API for gastroenterology.
Mesalamine Specifications | CAS 89-57-6
| Attribute | Details |
|---|---|
| Pharmacopoeia Standard | USP / EP |
| CAS Number | 89-57-6 |
| Molecular Formula | C₇H₇NO₃ |
| Molecular Weight | 153.14 g/mol |
| Therapeutic Application | Anti-inflammatory (IBD treatment) |
| DMF / EDMF Status | Available |
| Manufacturing Standard | WHO-GMP Certified |
| Appearance | White crystalline powder |
| Purity | ≥99% |
Diverse Applications
Gastroenterology
API for oral therapies for ulcerative colitis and Crohn’s disease
Generics
Widely used in global IBD therapy markets
Hospital Formulations
Critical drug for long-term management of IBD
Research
Used in studies of intestinal inflammation pathways
Our Mesalamine / Mesalazine Manufacturing Facility in India
As a WHO-GMP certified manufacturer, We are equipped for high-purity pharmaceutical intermediate production. Our Mesalamine / Mesalazine manufacturing line is purpose-built for controlled synthesis, ensuring batch-to-batch consistency and compliance with international pharmacopoeial standards.
WHO-GMP Certified Infrastructure
DK Pharmachem operates a dedicated WHO-GMP certified manufacturing facility in India, equipped for high-purity pharmaceutical intermediate production. Our Mesalamine / Mesalazine manufacturing line is purpose-built for controlled synthesis, ensuring batch-to-batch consistency and compliance with international pharmacopoeial standards.
Facility highlights to list as bullet points below this paragraph:
- Dedicated synthesis and processing units
- In-house HPLC and analytical quality control laboratory
- ISO-compliant raw material storage and handling
- ETP (Effluent Treatment Plant) for safe waste management
- Validated cleaning and production procedures
Production Capacity & Bulk Supply Capabilities
As a bulk Mesalamine / Mesalazine supplier in India, DK Pharmachem maintains scalable production capacity to meet both regular and high-volume procurement requirements. Our supply chain is designed to support uninterrupted manufacturing operations for our clients.
Supply capabilities to list as bullet points:
- Consistent monthly output to meet bulk order requirements
- Flexible packaging: HDPE drums, fiber drums, bulk options
- Shelf-stable formulation with documented storage guidelines
- Batch traceability from raw material to finished product
- COA, MSDS, and EDMF documentation provided with every shipment
Certifications & Regulatory Compliance
Every batch of Mesalamine / Mesalazine manufactured at our India facility is backed by:
- WHO-GMP Certification
- European Pharmacopoeia (EP) compliance
- British Pharmacopoeia (BP) compliance
- EDMF (European Drug Master File) registration
- Certificate of Analysis (COA) per batch
- Material Safety Data Sheet (MSDS) available on request
As one of the established Mesalamine / Mesalazine manufacturers in India, we ensure uninterrupted supply chains and strict adherence to global quality standards.
We supply bulk Mesalamine / Mesalazine from India
DK Pharmachem serves clients across pharmaceuticals, agrochemicals, water treatment, and contract manufacturing sectors. We maintain consistent stock availability to support both spot orders and long-term supply agreements.
As an established Mesalamine / Mesalazine exporter, we ship to regulated markets including Europe, North America, Southeast Asia, and the Middle East. All export shipments are accompanied by full documentation - COA, MSDS, EDMF, and country-specific regulatory filings where required.
Request a Quote
Partner with DK Pharmachem for consistent pharmaceutical-grade quality, reliable bulk supply, and comprehensive regulatory documentation. Get in touch with our team today to discuss your requirements, timelines, and pricing.
Packaging, Handling & Storage Guidelines
Mesalamine / Mesalazine powder is packed to maintain stability and ensure safe handling throughout the supply chain.
Packaging Options
- HDPE drums
- Fiber drums with inner liners
- Bulk packaging options available
Handling & Storage
- Store in a cool, dry, and well-ventilated area
- Protect from moisture and direct sunlight
- Keep containers tightly closed
- Follow standard safety precautions during handling
Proper storage preserves product quality and performance.
Why Choose DK Pharmachem for Mesalamine / Mesalazine sourcing?
Choosing the right sourcing partner for Mesalamine / Mesalazine means evaluating quality, regulatory standing, supply reliability, and long-term partnership capability. DK Pharmachem has been a trusted name in pharmaceutical intermediates for over four decades, built on a foundation of manufacturing excellence and customer trust.
Direct Manufacturer, Not a Trader
WHO-GMP Certified Manufacturing
EDMF Registration Support
EP/BP Compliant Product Quality
Comprehensive Technical & Export Documentation
Bulk Supply & Long-Term Contract Support
D.K. Pharmachem is trusted by pharmaceutical companies for consistent quality and dependable supply.
Frequently Asked Questions
Find answers to common questions about Mesalamine and Mesalazine products and services
What is the difference between Mesalamine and Mesalazine?
Mesalamine and Mesalazine are different names for the same active pharmaceutical ingredient — 5-Aminosalicylic acid (5-ASA), CAS 89-57-6. Mesalamine is the INN (International Nonproprietary Name) used in the United States (USP monograph). Mesalazine is the INN used in Europe (EP/BP), Japan, India, and most other global markets. DK Pharmachem supplies this API under both names and to both USP and EP/BP/IP pharmacopoeial specifications.
What pharmacopoeial grades of Mesalazine (5-ASA) does DK Pharmachem supply?
DK Pharmachem supplies Mesalamine / Mesalazine API conforming to BP (British Pharmacopoeia), USP (United States Pharmacopeia), EP (European Pharmacopoeia), and IP (Indian Pharmacopoeia) standards at ≥99% purity. This multi-pharmacopoeia compliance enables a single DK Pharmachem qualification to support regulatory filings across the US, EU, UK, and Indian markets.
What is the minimum order quantity for bulk Mesalamine / Mesalazine API?
DK Pharmachem supplies Mesalazine API from 1 kg upwards for formulation development and supplier qualification. Commercial bulk supply is available in 5 kg and 25 kg light-protected drum packs. Custom bulk configurations are available for high-volume tablet, capsule, suppository, and enema manufacturers — contact our team with your required quantity, grade, and timeline.