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Watson's Mesalazine API Production Pursuing DMF Registration in the EU and Japan

Mesalazine, also known as mesalamine, is a highly effective anti-inflammatory drug widely used in the treatment of inflammatory bowel diseases (IBD), particularly ulcerative colitis. Derived from 5-aminosalicylic acid (5-ASA), mesalazine boasts a well-established therapeutic profile, offering targeted relief and long-term benefits for patients.

Applications of Mesalazine

Mesalazine serves as the active component of sulfasalazine (SASP), delivering the therapeutic effects that make it indispensable in managing ulcerative colitis and Crohn’s disease. Its primary mechanism of action involves suppressing inflammation in the intestinal mucosa by targeting critical inflammatory pathways.

Primary Uses:

  • Treatment of Ulcerative Colitis: Effectively alleviates symptoms such as abdominal pain, diarrhea, and rectal bleeding.
  • Maintenance of Remission: Helps prevent relapses in patients with ulcerative colitis.
  • Management of Crohn’s Disease: Used in mild to moderate cases as part of a comprehensive treatment plan.

Characteristics and Advantages of Mesalazine

Key Characteristics:

  • Targeted Anti-inflammatory Action: Inhibits the synthesis of prostaglandins and the formation of leukotrienes, key mediators of inflammation.
  • Localized Delivery: Formulated to deliver the active ingredient directly to the inflamed intestinal mucosa for maximum efficacy.
  • Superior Safety Profile: Minimizes systemic side effects, making it suitable for long-term use.
  • Proven Clinical Outcomes: Demonstrates effectiveness in both inducing and maintaining remission in patients with ulcerative colitis.

Core Advantages:

  • High Local Efficacy: Minimal systemic absorption ensures precise targeting of inflammation.
  • Versatile Formulations: Available as tablets, granules, and rectal preparations to meet diverse patient needs.
  • Excellent Tolerability: Suitable for long-term treatment regimens with minimal adverse effects.

Watson’s Unique Strengths

Watson is a trusted leader in mesalazine API production, employing cutting-edge technology and a robust regulatory framework to ensure the consistent supply of high-quality products for global markets.

Regulatory Approvals:

  • Actively pursuing EU Certificate of Suitability (CEP) and Drug Master File (DMF) registration in Japan.

Operational Excellence:

  • Stringent Quality Standards: Adheres to international benchmarks, ensuring consistent product performance.
  • Global Export Capabilities: Supplies mesalazine to stringent regulatory markets, including Europe and Japan.
  • Regulatory Support: Provides comprehensive documentation and assistance to streamline market entry for pharmaceutical manufacturers.

Watson’s Market Competitiveness

Reliable Supply Chain:

  • Advanced Manufacturing Facilities: State-of-the-art facilities ensure efficient production and consistent quality.
  • Efficient Logistics: A robust network ensures uninterrupted supply to partners worldwide.

Customer-Centric Approach:

  • Customization: Offers tailored solutions, including specific particle sizes and formulations, to meet diverse customer needs.

Competitive Pricing:

Combines premium quality with cost-effective solutions, ensuring exceptional value for partners.

References

Mesalazine on Watson

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