01 1Zydus Lifesciences
01 1PITAVASTATIN CALCIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-29
DMF Number : 27333
Submission : 2013-07-31
Status : Active
Type : II
20
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 PITAVASTATIN CALCIUM, with a corresponding US DMF Number 27333.
Remarkably, this DMF maintains an Active status since its submission on July 31, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 22, 2013, and payment made on July 29, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
