01 1CTX Lifesciences
01 1IRBESARTAN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-21
Pay. Date : 2013-08-07
DMF Number : 24596
Submission : 2011-04-19
Status : Active
Type : II
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Ctx Life Sciences Pvt 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 IRBESARTAN USP, with a corresponding US DMF Number 24596.
Remarkably, this DMF maintains an Active status since its submission on April 19, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 21, 2014, and payment made on August 07, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
