01 1Unichem Laboratories Limited
01 1MIRABEGRON
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-22
Pay. Date : 2019-01-14
DMF Number : 33503
Submission : 2019-03-25
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 MIRABEGRON, with a corresponding US DMF Number 33503.
Remarkably, this DMF maintains an Active status since its submission on March 25, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 22, 2019, and payment made on January 14, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
