Shivalik Rasayan Files DMF for Avapritinib API with USFDA

Shivalik Rasayan Limited has successfully filed a Drug Master File (DMF) for its Avapritinib Active Pharmaceutical Ingredient (API) with the US Food and Drug Administration (USFDA). The company has received Complete Assessment (CA) for the filing. Avapritinib is a key component used in the treatment of Gastrointestinal Stromal Tumors (GIST) and is marketed by Sanofi under the brand name "Ayvakit". Ayvakit generated USD 700 million in revenue in 2025, indicating a significant market for the API Shivalik Rasayan is producing.