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.
- Ranitidine tablet is the first integrated product approval where the API and formulations will be manufactured at erstwhile Shasun Pharmaceuticals 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.
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.