Mesalamine api for Pharmaceutical Formulations
Amicus Lifesciences is a trusted manufacturer and global supplier of Mesalamine API, catering to the pharmaceutical industry worldwide. Our WHO-GMP and ISO-certified manufacturing facility ensures high purity, efficacy, and compliance with international regulatory standards.
What is Mesalamine?
Mesalamine, also known as 5-Aminosalicylic Acid (5-ASA), is an anti-inflammatory drug used to treat ulcerative colitis, Crohn’s disease, and other inflammatory bowel diseases (IBD). It works by reducing inflammation in the colon and intestines, providing relief from symptoms such as abdominal pain, diarrhea, and rectal bleeding.
Mesalmine specification?
Why Choose Amicus for of Mesalamine API
✔ WHO-GMP & ISO Certified Manufacturing – Ensuring the highest quality and safety.
✔ Global Export Expertise – Supplying to regulated and semi-regulated markets.
✔ High Purity & Consistency – Manufactured under strict cGMP guidelines.
✔ Custom Packaging & Bulk Supply – Tailored to client requirements.
✔ Reliable Logistics & On-Time Delivery – Seamless global shipping solutions.
Applications of Mesalamine API
Mesalamine API is widely used in:
🔹 Oral Tablets & Capsules – Sustained-release and delayed-release formulations for long-term IBD treatment.
🔹 Rectal Suppositories & Enemas – Used in treating proctitis and distal ulcerative colitis.
🔹 Combination Drugs – Often combined with corticosteroids or immunosuppressants for enhanced efficacy.
Regulatory & Compliance Support
Amicus Lifesciences provides complete documentation support for regulatory submissions, including:
✅ Drug Master File (DMF)
✅ Certificate of Analysis (COA)
✅ Material Safety Data Sheet (MSDS)
✅ Stability Data
fAQ
A: The typical shelf life is 2-3 years under recommended storage conditions.
A: Yes, we offer tailored packaging solutions as per client requirements.
A: We offer flexible payment terms and ensure fast, reliable global delivery.
Amicus Life Sciences is Leading Manufacturer of Mesalamine API
