01 1Hetero Drugs
01 1EFAVIRENZ (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-21
DMF Number : 24943
Submission : 2011-05-17
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 II), with a corresponding US DMF Number 24943.
Remarkably, this DMF maintains an Active status since its submission on May 17, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 09, 2013, and payment made on December 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
