01 1Alembic Pharmaceuticals Limited
01 1MACITENTAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-05
Pay. Date : 2017-04-17
DMF Number : 31664
Submission : 2017-04-28
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 MACITENTAN, with a corresponding US DMF Number 31664.
Remarkably, this DMF maintains an Active status since its submission on April 28, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 05, 2017, and payment made on April 17, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
