Choosing the Right Mesalamine Manufacturer: WHO-GMP, DMF & COA Checklist Table of Contents Mesalamine is a widely used active
Blog
By riya
January 22, 2026
Choosing the Right Mesalamine Manufacturer: WHO-GMP, DMF & COA Checklist
By riya
January 22, 2026
Choosing the Right Mesalamine Manufacturer: WHO-GMP, DMF & COA Checklist
Table of Contents
Mesalamine is a widely used active pharmaceutical ingredient (API) in the treatment of inflammatory bowel diseases such as ulcerative colitis. Due to its therapeutic importance and long-term use in many patients, the quality, consistency, and regulatory compliance of Mesalamine API are critical.
Selecting the right Mesalamine manufacturer is not only a procurement decision but also a quality and compliance responsibility. Regulatory approvals, documentation standards, and manufacturing practices directly impact the safety and effectiveness of the finished dosage form.
This blog outlines the key criteria to consider when choosing a Mesalamine manufacturer, with a practical focus on WHO-GMP certification, Drug Master File (DMF) availability, and Certificate of Analysis (COA) verification. Together, these elements form a reliable checklist for informed decision-making.
Understanding Mesalamine and Its Importance
Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is an anti-inflammatory agent primarily used to manage chronic inflammatory conditions of the gastrointestinal tract. It works locally in the intestine to reduce inflammation and maintain remission in patients.
Because Mesalamine is often prescribed for long-term use, its purity, stability, and batch-to-batch consistency are essential. Any compromise in API quality can affect therapeutic outcomes and patient safety, making manufacturer selection a critical step for pharmaceutical companies and formulators.
Why Manufacturer Selection Matters
The manufacturer of Mesalamine API plays a central role in determining the overall quality of the finished pharmaceutical product. A reliable manufacturer ensures:
- Consistent API quality
- Compliance with international regulatory standards
- Transparent documentation
- Reduced risk of regulatory observations or recalls
WHO-GMP Certification: What to Check
WHO-GMP (World Health Organization – Good Manufacturing Practices) certification is one of the most important indicators of a manufacturer’s quality systems.
When evaluating WHO-GMP compliance, consider the following:
Valid Certification
Ensure that the WHO-GMP certificate is:
- Issued by a recognized regulatory authority
- Currently valid
- Applicable specifically to Mesalamine API production
Scope of Approval
The certificate should clearly mention:
- API manufacturing
- Relevant dosage forms or intermediates, if applicable
- Approved manufacturing site address
Audit History
A credible manufacturer should be able to share:
- Recent audit outcomes
- Corrective and preventive actions (CAPA), if applicable
- Inspection readiness documentation
WHO-GMP certification confirms that the manufacturer follows standardized procedures for production, quality control, documentation, and personnel training.
DMF Availability and Regulatory Transparency
A Drug Master File (DMF) is a confidential document submitted to regulatory authorities that provides detailed information about the API’s manufacturing process, quality controls, and stability data.
Why DMF Matters
DMF availability demonstrates:
- Regulatory preparedness
- Transparency in manufacturing processes
- Support for global market registrations
What to Verify in a DMF
When assessing a Mesalamine manufacturer, confirm:
- Type of DMF (US DMF, CEP, or regional equivalent)
- DMF status (active and up to date)
- Willingness to provide a Letter of Access (LoA)
An updated and well-maintained DMF reduces regulatory delays and simplifies product approvals in regulated and semi-regulated markets.
COA Checklist for Mesalamine API
The Certificate of Analysis (COA) is a critical document that verifies the quality of each API batch. A complete and accurate COA ensures traceability and compliance.
Key Elements to Review in the COA
Identification Tests
- Confirms the API is Mesalamine
- Matches pharmacopeial standards (USP, EP, BP, or IP)
Assay and Purity
- Assay values within specified limits
- Impurity profile clearly reported
Physical Parameters
- Appearance
- Particle size (if applicable)
- Loss on drying or moisture content
Microbiological Testing
- Total microbial count
- Absence of specified
- pathogens, if required
Batch Information
- Batch number
- Manufacturing date
- Retest or expiry date
The COA should be signed, dated, and issued by the manufacturer’s quality control department. Any inconsistencies between specifications and results should be clarified before approval.
Additional Factors to Consider
Beyond WHO-GMP, DMF, and COA, a few additional aspects strengthen manufacturer evaluation:
- Manufacturing capacity and scalability
- Supply chain reliability
- Change control procedures
- Stability data availability
- Technical support and responsiveness
A manufacturer that offers clear communication and technical documentation support adds long-term value beyond API supply.
Final Thoughts
Choosing the right Mesalamine manufacturer requires a structured and compliance-focused approach. WHO-GMP certification ensures robust manufacturing practices, DMF availability supports regulatory submissions, and a thorough COA review confirms batch quality.
By following a clear checklist and prioritizing documentation transparency, pharmaceutical companies can reduce regulatory risks, maintain consistent product quality, and ensure patient safety. A well-qualified manufacturer becomes a reliable partner in long-term pharmaceutical development and supply.
FAQs
Why is WHO-GMP certification important for Mesalamine manufacturers?
WHO-GMP certification confirms that the manufacturer follows globally accepted quality standards, ensuring consistent production, proper documentation, and controlled processes essential for safe and effective Mesalamine API.
What is a DMF, and why should a Mesalamine manufacturer have one?
A DMF provides detailed information about API manufacturing and quality controls. It supports regulatory submissions and demonstrates transparency, helping pharmaceutical companies obtain product approvals more efficiently.
What details should be checked in a Mesalamine API COA?
A Mesalamine COA should include identification tests, assay results, impurity limits, physical parameters, microbiological data, batch details, and authorized quality control approval for regulatory compliance.
Can Mesalamine API be sourced without DMF support?
While possible in some markets, a lack of DMF support may delay approvals and increase regulatory challenges, especially in regulated regions where detailed API documentation is mandatory.
How does manufacturer selection affect finished dosage quality?
The API manufacturer directly influences the purity, consistency, and stability of the finished product. A qualified manufacturer reduces risks related to recalls, compliance issues, and therapeutic variability.