01 1Unimark Remedies
01 1FLECAINIDE ACETATE USP (PROCESS B)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-02-01
DMF Number : 23192
Submission : 2009-10-14
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 FLECAINIDE ACETATE USP (PROCESS B), with a corresponding US DMF Number 23192.
Remarkably, this DMF maintains an Active status since its submission on October 14, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 07, 2014, and payment made on February 01, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
