01 1Ercros
01 1ERYTHROMYCIN BASE DIHYDRATE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-15
Pay. Date : 2023-01-18
DMF Number : 37397
Submission : 2022-09-14
Status : Active
Type : II
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Ercros Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is ERYTHROMYCIN BASE DIHYDRATE, with a corresponding US DMF Number 37397.
Remarkably, this DMF maintains an Active status since its submission on September 14, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 15, 2023, and payment made on January 18, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
