01 1Amoli Organics
01 1DICLOFENAC POTASSIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-16
DMF Number : 23028
Submission : 2009-08-12
Status : Active
Type : II
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Amoli Organics Private 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 POTASSIUM USP, with a corresponding US DMF Number 23028.
Remarkably, this DMF maintains an Active status since its submission on August 12, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2017, and payment made on October 16, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
