01 1Ipca Laboratories
01 1CETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-30
Pay. Date : 2012-12-10
DMF Number : 26033
Submission : 2012-05-23
Status : Active
Type : II
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Ipca Laboratories 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 CETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS), with a corresponding US DMF Number 26033.
Remarkably, this DMF maintains an Active status since its submission on May 23, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 30, 2013, and payment made on December 10, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
