01 1Jubilant Generics
01 1AZITHROMYCIN MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-12-17
DMF Number : 18868
Submission : 2005-10-14
Status : Active
Type : II
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Jubilant Biosys 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 AZITHROMYCIN MONOHYDRATE USP, with a corresponding US DMF Number 18868.
Remarkably, this DMF maintains an Active status since its submission on October 14, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 23, 2012, and payment made on December 17, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
