01 1Unimark Remedies
01 1NITROFURANTOIN MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-07-22
DMF Number : 23501
Submission : 2010-02-16
Status : Active
Type : II
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Unimark Remedies Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is NITROFURANTOIN MONOHYDRATE USP, with a corresponding US DMF Number 23501.
Remarkably, this DMF maintains an Active status since its submission on February 16, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2013, and payment made on July 22, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
