01 1Alembic Pharmaceuticals Limited
01 1PRUCALOPRIDE SUCCINATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-24
Pay. Date : 2023-08-11
DMF Number : 37911
Submission : 2023-08-17
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 PRUCALOPRIDE SUCCINATE, with a corresponding US DMF Number 37911.
Remarkably, this DMF maintains an Active status since its submission on August 17, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2023, and payment made on August 11, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
