01 1Hetero Drugs
01 1ZIDOVUDINE (PROCESS I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2013-01-18
DMF Number : 18291
Submission : 2005-04-20
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 ZIDOVUDINE (PROCESS I), with a corresponding US DMF Number 18291.
Remarkably, this DMF maintains an Active status since its submission on April 20, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 06, 2013, and payment made on January 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
