Mesalamine Delayed Release Tablets 800mg

Mesalamine Delayed Release Tablets  800mg 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 800mg

Mesalamine Delayed Release Tablets 800mg are potent anti-inflammatory tablets designed to treat and maintain remission of ulcerative colitis, a chronic condition causing inflammation, swelling, and sores in the lining of the colon and rectum. Belonging to the class of medications known as anti-inflammatory agents, Mesalamine works directly in the colon to reduce inflammation, control bleeding, and relieve abdominal pain.

In recent years, the global demand for Mesalamine 800mg tablets has increased due to the rising prevalence of inflammatory bowel diseases (IBD) and growing awareness of effective maintenance therapy. Healthcare providers and pharmaceutical distributors are actively seeking reliable, high-quality manufacturers and exporters.

Taj Pharma stands out as a trusted Mesalamine Delayed Release Tablets 800mg manufacturer in India, providing WHO-GMP-certified products that meet stringent international quality standards.

Trusted Manufacturer, Exporter, and Supplier

Based in Vapi, Gujarat, India, Taj Pharma Ltd is a leading Mesalamine Delayed Release Tablets 800mg manufacturer in India. Known for delivering high-quality, pure, and globally compliant pharmaceutical products, Taj Pharma has earned a reputation among hospitals, pharmacies, and international distributors.

Key Benefits of Mesalamine Delayed Release Tablets 800mg:

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

• Maintenance Therapy: Helps maintain remission in ulcerative colitis patients

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

• Global Compliance: Export-ready with full regulatory documentation

Clinical Use and Administration

Mesalamine Delayed Release Tablets 800mg are prescribed for:

• Ulcerative colitis – treatment and maintenance of symptom remission

• Crohn’s ileocolitis – when recommended by a physician

Dosage and Administration Guidelines:

• Take orally with food, as directed by a doctor

• Follow the prescribed dose strictly to prevent relapse

• Do not stop treatment abruptly, even if symptoms improve

• Maintain regular follow-ups with your physician

Safety Notes:

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

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

• Precaution: Inform your doctor about liver/kidney issues, allergies, or concurrent medications

Global Demand and Market Potential

With increasing IBD cases worldwide, Mesalamine Delayed Release Tablets 800mg have a significant global market. Hospitals, clinics, and pharmacies are actively sourcing reliable suppliers to meet patient needs.

Key Export Markets:

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

• Asia: India, Bangladesh, Philippines, Malaysia, Sri Lanka

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

• Africa: South Africa, Kenya, Egypt, Nigeria

• North & 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, and strips with multilingual labeling

• Private labeling for PCD franchise and distributors

• Export-compliant packaging ensures safe international delivery

Shelf-Life, Storage, and Dosage Form

• Form: 800mg delayed-release tablet

• Shelf-Life: 24–36 months

• Storage: Store below 30°C, away from moisture and direct 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 equipped with cutting-edge machinery, ensuring precision, consistency, and top-quality production of Mesalamine Delayed Release Tablets 800mg.

2. Affordable Pricing with Quality Assurance

The company provides competitive pricing while ensuring strict quality control, making it an ideal choice for domestic and international buyers.

3. Global Presence and Supply Chain Support

• Timely shipments to 40+ countries

• Comprehensive support for regulatory documentation, customs clearance, and logistics

• Reliable and uninterrupted international supply chain

4. Top Export Destinations

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

• Ensuring access to emerging and developed markets

Technical Product Specification Table

Distributors, importers, and PCD franchise partners seeking a reliable Mesalamine Delayed Release Tablets 800mg 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 800mg 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, 800mg 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, abdominal pain, headache, flatulence, vomiting, itching.

7. Severe allergic reactions?
   Swelling of face, lips, tongue, throat, rash, fever, unusual bleeding – 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, consult a doctor.

17. Can it be used for Crohn’s disease?
    Yes, if prescribed.

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.

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