01 1Amoli Organics
01 1ATORVASTATIN CALCIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-07
Pay. Date : 2019-06-25
DMF Number : 25346
Submission : 2011-11-04
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 ATORVASTATIN CALCIUM USP, with a corresponding US DMF Number 25346.
Remarkably, this DMF maintains an Active status since its submission on November 04, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 07, 2019, and payment made on June 25, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
