01 1Zydus Lifesciences
01 1LURASIDONE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2014-05-19
DMF Number : 28281
Submission : 2014-06-12
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 LURASIDONE HYDROCHLORIDE, with a corresponding US DMF Number 28281.
Remarkably, this DMF maintains an Active status since its submission on June 12, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 28, 2014, and payment made on May 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
