Mesalamine Delayed Release Tablets 400mg

Mesalamine Delayed Release Tablets  400mg Technical Specification: 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Mesalamine Delayed Release Tablets USP 1200mg (Meslataj-DR)
B. Mesalamine Delayed Release Tablets USP 800mg (Meslataj-DR)
C. Mesalamine Delayed Release Tablets USP 400mg (Meslataj-DR)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Mesalamine Delayed Release Tablets USP 1200mg
Each film-coated delayed release tablet contains:
Mesalamine USP …………………1200mg
Excipients……………………………..q.s.
Colour: Iron Oxide Red and Ferric Oxide Red USP-NF

B. Mesalamine Delayed Release Tablets USP 800mg
Each film-coated delayed release tablet contains:
Mesalamine USP …………………800mg
Excipients………………………………q.s.
Colour: Iron Oxide Red and Ferric Oxide Red USP-NF

C. Mesalamine Delayed Release Tablets USP 400mg
Each film-coated delayed release tablet contains:
Mesalamine USP …………………400mg
Excipients……………………………..q.s.
Colour: Iron Oxide Red and Ferric Oxide Red USP-NF

THERAPEUTIC INDICATIONS:

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease. They are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of Asacol for the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

CAUTION & WARNING:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.

Warning: To be sold by retail on the prescription of a Specialist/Gastroenterologist.

STORAGE & DOSAGE:

Storage: Store at 25°C. Keep in cool & Dry place. Protect from Light. Do not refrigerate.
Read enclosed leaflet before use.
Keep medicine out of reach of children.

Dosage: As directed by the Physician.

Introduction to Mesalamine Delayed Release Tablets 400mg

Mesalamine Delayed Release Tablets 400mg are specialized anti-inflammatory tablets prescribed for the treatment and maintenance of ulcerative colitis, a condition that causes swelling and sores in the lining of the colon and rectum. Belonging to a class of medications called anti-inflammatory agents, Mesalamine works locally in the colon to reduce inflammation and maintain remission of ulcerative colitis symptoms.

With the growing global prevalence of inflammatory bowel diseases (IBD), the demand for Mesalamine Delayed Release Tablets 400mg has risen significantly. Patients and healthcare providers are increasingly looking for high-quality, reliable, and WHO-GMP-certified suppliers, making Taj Pharma a preferred manufacturer and exporter in India.

Trusted Manufacturer, Exporter, and Supplier

Based in Vapi, Gujarat, India, Taj Pharma Ltd is a leading Mesalamine Delayed Release Tablets 400mg manufacturer in India. The company is renowned for delivering high-quality, pure, and globally compliant pharmaceutical products.

Key Benefits of Mesalamine Delayed Release Tablets 400mg:

• Effective Relief: Reduces diarrhea, rectal bleeding, abdominal pain, and inflammation

• Reliable Maintenance: Helps maintain remission in ulcerative colitis patients

• Safe & Trusted: Produced under WHO-GMP and EU-GMP standards

• Global Compliance: Export-ready with regulatory documentation for international markets

Clinical Use and Administration

Mesalamine Delayed Release Tablets 400mg are primarily used to treat:

• Ulcerative colitis – reducing symptoms and maintaining remission

• Crohn’s ileocolitis – when prescribed by a healthcare professional

Dosage and Administration:

• Taken orally with food, as directed by a physician

• The dose depends on the condition being treated

• Regular use is essential; stopping early may cause relapse

• Patients should follow medical advice strictly to ensure optimal results

Safety Notes:

• Common side effects: Nausea, diarrhea, abdominal pain, headache, flatulence, vomiting, itching

• Serious allergic reactions: Swelling of face, tongue, throat, lips; unusual bleeding or bruising; rash; fever – seek immediate medical attention

• Precaution: Always inform your doctor about allergies, liver or kidney issues, or concurrent medications

Global Demand and Market Potential

The prevalence of inflammatory bowel diseases is on the rise, especially in Europe, North America, Asia, and the Middle East. This growth creates a high demand for Mesalamine Delayed Release Tablets 400mg among hospitals, pharmacies, and distributors.

Key Export Markets:

• Europe: Germany, France, UK, Spain, Poland

• Asia: India, Bangladesh, Sri Lanka, Philippines

• Middle East: UAE, Saudi Arabia, Oman, Qatar

• Africa: South Africa, Kenya, Nigeria, Egypt

• North America & Latin America: USA, Canada, Brazil, Mexico

In-Depth Details for Importers and Exporters

Regulatory Documentation Provided

• WHO-GMP Certificate

• EU-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Certificate of Origin (COO)

• Free Sale Certificate

• CTD/DMF Dossier

• Stability and batch testing reports

Custom Packaging & Labeling

• Blister packs, bottles, strips with multilingual labeling

• Private labeling and PCD franchise opportunities

• Export-compliant packaging ensures safety during shipping

Shelf-Life, Storage, and Dosage Form

• Form: 400mg delayed-release tablet

• Shelf-Life: 24–36 months

• Storage: Below 30°C, away from moisture and sunlight

Export Certifications

• WHO-GMP, EU-GMP, ISO 9001:2015

• COPP, COA, CTD/DMF dossiers provided

• ICH-compliant stability studies for international quality standards

Why is the Most Trusted Manufacturer and Exporter

1. State-of-the-Art Manufacturing

Taj Pharma operates advanced WHO-GMP-certified facilities with high-end machinery, ensuring consistency, precision, and quality in every batch of Mesalamine Delayed Release Tablets 400mg.

2. Affordable Pricing with Quality Assurance

The company offers competitive pricing without compromising on quality, making it ideal for domestic and international buyers.

3. Global Presence and Supply Chain Support

• Timely shipments to over 40 countries

• Support for regulatory documentation, customs clearance, and logistics

• Reliable and uninterrupted international supply chain

4. Top Export Destinations

• Europe, Asia, Middle East, Africa, North America & Latin America

• Ensuring seamless access to both emerging and developed markets

Technical Product Specification Table

Distributors, importers, and PCD franchise partners seeking a reliable Mesalamine Delayed Release Tablets 400mg manufacturer in India can benefit from:

• WHO-GMP-certified quality

• Complete regulatory documentation

• Competitive pricing and consistent supply

• Timely international delivery

Contact Taj Pharma:
📍 Address: Taj Pharma Ltd, Vapi, Gujarat, India
🌐 Website: www.tajpharma.com
📧 Email: info@tajpharma.com
📞 Phone: +91 74 0000 9975

Top 20 FAQs 

1. What is Mesalamine 400mg used for?
   Treats ulcerative colitis and maintains remission.

2. Who manufactures it in India?
   Taj Pharma Ltd, Vapi, Gujarat.

3. Dosage form and strength?
   Delayed-release tablet, 400mg Mesalamine.

4. How should it be taken?
   With food, exactly as prescribed.

5. Can it be used long-term?
   Yes, under medical supervision.

6. Common side effects?
   Nausea, diarrhea, stomach pain, headache, flatulence, vomiting, itching.

7. Serious allergic reactions?
   Swelling of face, tongue, throat, lips, unusual bleeding or bruising, rash, fever – seek immediate medical attention.

8. Storage conditions?
   Store below 30°C, away from moisture.

9. Shelf life?
   24–36 months.

10. Private labeling available?
    Yes, for PCD franchise and distributors.

11. Certifications provided?
    WHO-GMP, EU-GMP, ISO 9001:2015.

12. Can it be exported?
    Yes, globally.

13. Documentation included?
    COPP, COA, CTD/DMF, stability data.

14. Target export countries?
    Europe, Asia, Middle East, Africa, North & Latin America.

15. Is it safe during pregnancy?
    Only under physician supervision.

16. Can it interact with other medicines?
    Yes, always consult a doctor for potential interactions.

17. Can it be taken for Crohn’s disease?
    Yes, if prescribed by a doctor.

18. How to handle missed doses?
    Take as soon as remembered; do not double the next dose.

19. Lifestyle considerations?
    Follow dietary and medical advice for better results.

20. How to become a PCD partner?
    Contact Taj Pharma via email or phone.