01 1Amoli Organics
01 1DICLOFENAC
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-12
Pay. Date : 2014-05-19
DMF Number : 28208
Submission : 2014-04-18
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 DICLOFENAC, with a corresponding US DMF Number 28208.
Remarkably, this DMF maintains an Active status since its submission on April 18, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 12, 2014, and payment made on May 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
