How to Source Mesalamine (5-ASA) tablets for Pharmaceutical Formulation
Mesalamine (5-ASA) tablets (Tablets, 400 mg, 500 mg, and 1 g) is classified under Gastrointestinal Drugs. It is therapeutically aligned with reference brands such as Asacol HD, Lialda, Pentasa(US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Mesalamine (5-ASA) tablets for formulation, R&D, or bulk manufacturing.
Product Overview:
Mesalamine (5-ASA) tablets and capsules are anti-inflammatory agents that release in the intestine, reducing inflammation by inhibiting prostaglandin synthesis. They effectively treat ulcerative colitis and Crohn’s disease, providing symptom relief, mucosal healing, and improved quality of life. Benefits include decreased inflammation, fewer flares, and better disease control.
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
Mesalamine (5-ASA) tablets must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for Mesalamine (5-ASA) tablets is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing Mesalamine (5-ASA) tablets is more than procurement—it’s a strategic partnership. With its tablets form and 400 mg, 500 mg, and 1 g specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing Mesalamine (5-ASA) tablets.
Frequently Asked Questions For Sourcing of Mesalamine (5-ASA) tablets
What is the typical lead time for Mesalamine (5-ASA) tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Mesalamine (5-ASA) tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Mesalamine (5-ASA) tablets require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Mesalamine (5-ASA) tablets?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Mesalamine (5-ASA) tablets?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Mesalamine (5-ASA) tablets?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Mesalamine (5-ASA) tablets suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Mesalamine (5-ASA) tablets be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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