01 1Zydus Lifesciences
01 1ELTROMBOPAG OLAMINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-08
Pay. Date : 2020-09-30
DMF Number : 34991
Submission : 2020-07-07
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 ELTROMBOPAG OLAMINE, with a corresponding US DMF Number 34991.
Remarkably, this DMF maintains an Active status since its submission on July 07, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 08, 2020, and payment made on September 30, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
