01 1Alembic Pharmaceuticals Limited
01 1NISOLDIPINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-23
Pay. Date : 2013-09-26
DMF Number : 25365
Submission : 2011-10-07
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 NISOLDIPINE, with a corresponding US DMF Number 25365.
Remarkably, this DMF maintains an Active status since its submission on October 07, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 23, 2014, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
