01 1Hetero Drugs
01 1EFAVIRENZ (PROCESS I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-12-04
DMF Number : 20015
Submission : 2006-12-05
Status : Active
Type : II
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Hetero Labs 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 EFAVIRENZ (PROCESS I), with a corresponding US DMF Number 20015.
Remarkably, this DMF maintains an Active status since its submission on December 05, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 26, 2012, and payment made on December 04, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
