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Strides Shasun receives USFDA approval for Ranitidine Tablets

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Strides Shasun Limited on August 24 announced that it has received approval from the United States Food & Drug Administration (USFDA) for Ranitidine Tablets USP, 150 mg and 300 mg.

Key Takeaways

  • Ranitidine tablet is the first integrated product approval where the API and formulations will be manufactured at erstwhile Shasun Pharmaceutical’s Cuddalore and Puducherry facilities respectively.
  • According to IMS data (MAT June 2016), the US market for Ranitidine Tablets USP, 150 mg and 300 mg. is approximately USD 125 Million.
  • The product to be launched immediately will be marketed by Strides Pharma Inc in the US Market.

Understanding Ranitidine Tablets

  • Known as an H2 histamine blocker.
  • Also available without a prescription.
  • Used to treat ulcers of the stomach and intestines and prevent them from returning after treatment.
  • Used to treat and prevent certain stomach and throat problems caused by too much stomach acid (e.g., Zollinger-Ellison syndrome, erosive esophagitis) or a backward flow of stomach acid into the esophagus (gastroesophageal reflux disease-GERD).
  • Used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach.
Arun Kumar, Founder, Vice Chairman and Managing Director, Strides Shasun

Arun Kumar, Founder, Vice Chairman and Managing Director, Strides Shasun

Overview of Strides Shasun

  • A vertically integrated global pharmaceutical Company headquartered in Bengaluru.
  • The Company has four business verticals, viz., Regulated Markets, Emerging Markets, Institutional Business and Pharmaceutical Services & Active Ingredients.
  • Has global manufacturing foot print with 14 manufacturing facilities spread across three continents including 6 US FDA approved facilities and 8 facilities for the emerging markets.
  • Has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries.

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