01 1Alembic Pharmaceuticals Limited
01 1LENALIDOMIDE (FORM-H1)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-20
Pay. Date : 2020-02-28
DMF Number : 34650
Submission : 2020-02-28
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 LENALIDOMIDE (FORM-H1), with a corresponding US DMF Number 34650.
Remarkably, this DMF maintains an Active status since its submission on February 28, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 20, 2020, and payment made on February 28, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
