01 1Alembic Pharmaceuticals Limited
01 1SACUBITRIL VALSARTAN TRISODIUM HEMIPENTAHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-14
Pay. Date : 2019-02-25
DMF Number : 33570
Submission : 2019-03-22
Status : Active
Type : II
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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 SACUBITRIL VALSARTAN TRISODIUM HEMIPENTAHYDRATE, with a corresponding US DMF Number 33570.
Remarkably, this DMF maintains an Active status since its submission on March 22, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 14, 2019, and payment made on February 25, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
