KEY PRODUCTS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 1Granules India Limited
01 1DASATINIB MONOHYDRATE
01 1India
01 1Active
01 1Complete
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-05
Pay. Date : 2025-08-04
DMF Number : 38065
Submission : 2023-03-31
Status : Active
Type : II
20
Granules India Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
One of their notable products is DASATINIB MONOHYDRATE, with a corresponding US DMF Number 38065.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 05, 2025, and payment made on August 04, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
