01 1Intas Pharmaceuticals
01 1PREGABALIN USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-29
Pay. Date : 2021-11-17
DMF Number : 36519
Submission : 2021-11-22
Status : Active
Type : II
20
Intas Pharmaceuticals 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 PREGABALIN USP (PROCESS-II), with a corresponding US DMF Number 36519.
Remarkably, this DMF maintains an Active status since its submission on November 22, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 29, 2021, and payment made on November 17, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
