01 1Aurobindo Pharma Limited
01 1OLANZAPINE USP (CRYSTALLINE POLYMORPH FORM-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-11
Pay. Date : 2015-09-24
DMF Number : 29789
Submission : 2015-09-29
Status : Active
Type : II
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Apitoria Pharma 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 OLANZAPINE USP (CRYSTALLINE POLYMORPH FORM-II), with a corresponding US DMF Number 29789.
Remarkably, this DMF maintains an Active status since its submission on September 29, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 11, 2016, and payment made on September 24, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
