01 1Unichem Laboratories Limited
01 1IRBESARTAN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-15
Pay. Date : 2013-09-06
DMF Number : 23835
Submission : 2010-06-04
Status : Active
Type : II
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Unichem 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 IRBESARTAN USP, with a corresponding US DMF Number 23835.
Remarkably, this DMF maintains an Active status since its submission on June 04, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 15, 2013, and payment made on September 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
