01 1Zydus Lifesciences
01 1ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-04
DMF Number : 20769
Submission : 2007-08-10
Status : Active
Type : II
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Zydus Lifesciences 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 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP, with a corresponding US DMF Number 20769.
Remarkably, this DMF maintains an Active status since its submission on August 10, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 07, 2014, and payment made on April 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
