01 1Hetero Drugs
01 1GABAPENTIN (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-15
Pay. Date : 2017-06-20
DMF Number : 31819
Submission : 2017-07-24
Status : Active
Type : II
20
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 GABAPENTIN (PROCESS-II), with a corresponding US DMF Number 31819.
Remarkably, this DMF maintains an Active status since its submission on July 24, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 15, 2017, and payment made on June 20, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
