01 1Zydus Lifesciences
01 1RANOLAZINE (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-09
Pay. Date : 2015-12-21
DMF Number : 29736
Submission : 2016-01-01
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 RANOLAZINE (PROCESS II), with a corresponding US DMF Number 29736.
Remarkably, this DMF maintains an Active status since its submission on January 01, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 09, 2016, and payment made on December 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
