01 1Hetero Drugs
01 1EFAVIRENZ (PROCESS III) USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-04
DMF Number : 25262
Submission : 2011-09-06
Status : Active
Type : II
20
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 III) USP, with a corresponding US DMF Number 25262.
Remarkably, this DMF maintains an Active status since its submission on September 06, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 07, 2013, and payment made on January 04, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
