01 1Aurobindo Pharma Limited
01 1LAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-21
DMF Number : 23601
Submission : 2010-02-26
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 LAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I), with a corresponding US DMF Number 23601.
Remarkably, this DMF maintains an Active status since its submission on February 26, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2012, and payment made on November 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
