Shivalik Files USFDA DMF for Avapritinib API

Key Development

Shivalik Rasayan Limited has successfully filed a Drug Master File (DMF) for Avapritinib API with the US Food and Drug Administration (USFDA). The company has completed the Complete Assessment (CA) for this filing.

Product Details

The Avapritinib API is used in the treatment of Gastrointestine Stromal Tumors (GIST). The product is originally developed by Sanofi and is marketed under the brand name "Ayvakit".

Market Context

Sanofi's Ayvakit brand achieved revenue of 700 million USD during the calendar year 2025, indicating significant market presence for this pharmaceutical product.