01 1Hetero Drugs
01 1APREPITANT
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-10-01
DMF Number : 25572
Submission : 2011-12-12
Status : Active
Type : II
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Hetero Drugs 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 APREPITANT, with a corresponding US DMF Number 25572.
Remarkably, this DMF maintains an Active status since its submission on December 12, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2014, and payment made on October 01, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
