01 1CTX Lifesciences
01 1CARVEDILOL (ROUTE-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-04
Pay. Date : 2021-04-29
DMF Number : 24096
Submission : 2010-08-12
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 CARVEDILOL (ROUTE-II), with a corresponding US DMF Number 24096.
Remarkably, this DMF maintains an Active status since its submission on August 12, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 04, 2021, and payment made on April 29, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
