01 1Hetero Drugs
01 1DACLATASVIR DIHYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-07
Pay. Date : 2016-09-28
DMF Number : 30975
Submission : 2016-10-07
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 DACLATASVIR DIHYDROCHLORIDE, with a corresponding US DMF Number 30975.
Remarkably, this DMF maintains an Active status since its submission on October 07, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 07, 2016, and payment made on September 28, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
