01 1Alembic Pharmaceuticals Limited
01 1ACALABRUTINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-30
Pay. Date : 2021-06-18
DMF Number : 36029
Submission : 2021-06-30
Status : Active
Type : II
20
Alembic Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is ACALABRUTINIB, with a corresponding US DMF Number 36029.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 30, 2021, and payment made on June 18, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
