01 1Amoli Organics
01 1DICLOFENAC SODIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-07-10
DMF Number : 20849
Submission : 2007-09-13
Status : Active
Type : II
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Amoli Organics (a Division Of Umedica Laboratories 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 DICLOFENAC SODIUM USP, with a corresponding US DMF Number 20849.
Remarkably, this DMF maintains an Active status since its submission on September 13, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 23, 2013, and payment made on July 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
