01 1Unichem Laboratories Limited
01 1PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2013-07-24
DMF Number : 25907
Submission : 2012-03-30
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 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP, with a corresponding US DMF Number 25907.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 07, 2014, and payment made on July 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
