01 1Hetero Drugs
01 1TENOFOVIR DISOPROXIL FUMARATE (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-23
Pay. Date : 2016-09-29
DMF Number : 31010
Submission : 2016-12-01
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 TENOFOVIR DISOPROXIL FUMARATE (PROCESS II), with a corresponding US DMF Number 31010.
Remarkably, this DMF maintains an Active status since its submission on December 01, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 23, 2017, and payment made on September 29, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
