01 1Zydus Lifesciences
01 1MESALAMINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-08
Pay. Date : 2012-12-18
DMF Number : 22999
Submission : 2009-07-31
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 MESALAMINE USP, with a corresponding US DMF Number 22999.
Remarkably, this DMF maintains an Active status since its submission on July 31, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 08, 2013, and payment made on December 18, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
