01 1Hetero Drugs
01 1ETRAVIRINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-22
Pay. Date : 2014-05-15
DMF Number : 25550
Submission : 2011-12-01
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 ETRAVIRINE, with a corresponding US DMF Number 25550.
Remarkably, this DMF maintains an Active status since its submission on December 01, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 22, 2014, and payment made on May 15, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
