01 1Zydus Lifesciences
01 1PREGABALIN USP (PGC ROUTE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-12-18
DMF Number : 27792
Submission : 2013-12-26
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 PREGABALIN USP (PGC ROUTE), with a corresponding US DMF Number 27792.
Remarkably, this DMF maintains an Active status since its submission on December 26, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 22, 2014, and payment made on December 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
