01 1Amoli Organics
01 1SILDENAFIL CITRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2013-09-03
DMF Number : 25311
Submission : 2011-11-02
Status : Active
Type : II
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Amoli Organics Pvt 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 SILDENAFIL CITRATE USP, with a corresponding US DMF Number 25311.
Remarkably, this DMF maintains an Active status since its submission on November 02, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 15, 2014, and payment made on September 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
