USFDA22 May 2024, 03:13 pm
Strides Pharma Receives USFDA Approval for Sucralfate Oral Suspension, Expanding its US Portfolio
AI Summary
Strides Pharma Science Ltd, a global pharmaceutical company, has announced that its subsidiary, Strides Pharma Global Pte. Ltd in Singapore, has received approval from the US Food and Drug Administration (USFDA) for the generic version of Sucralfate Oral Suspension, 1gm/10 mL. This approval marks the first for an Indian company for this complex formulation in the US. The product, used to treat various gastrointestinal diseases, has a market size of around USS 124Mn as per IQVIA. Strides plans to launch around 60 new products in the US over the next three years.
Key Highlights
- Strides receives first Indian approval from USFDA for Sucralfate Oral Suspension, 1gm/10 mL
- Approval adds differentiated and niche product with limited competition to Strides' US portfolio
- Sucralfate Oral Suspension, which treats stomach ulcers and GERD among other diseases, has a market size of ~USS 124Mn
- Strides sets target to launch around 60 new products in the US over the next three years