01 1Alembic Pharmaceuticals Limited
01 1ERYTHROMYCIN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-15
Pay. Date : 2015-09-30
DMF Number : 22695
Submission : 2009-03-27
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 ERYTHROMYCIN USP, with a corresponding US DMF Number 22695.
Remarkably, this DMF maintains an Active status since its submission on March 27, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2015, and payment made on September 30, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
