01 1Alembic Pharmaceuticals Limited
01 1ASENAPINE MALEATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-19
Pay. Date : 2013-08-08
DMF Number : 27194
Submission : 2013-07-04
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 ASENAPINE MALEATE, with a corresponding US DMF Number 27194.
Remarkably, this DMF maintains an Active status since its submission on July 04, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 19, 2013, and payment made on August 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
