01 1Alembic Pharmaceuticals Limited
01 1SELEXIPAG
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-12
Pay. Date : 2019-07-16
DMF Number : 33974
Submission : 2019-07-30
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 SELEXIPAG, with a corresponding US DMF Number 33974.
Remarkably, this DMF maintains an Active status since its submission on July 30, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 12, 2019, and payment made on July 16, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
