01 1Raks Pharma
01 1BREXPIPRAZOLE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-25
Pay. Date : 2018-12-20
DMF Number : 33451
Submission : 2018-12-26
Status : Active
Type : II
20
Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is BREXPIPRAZOLE, with a corresponding US DMF Number 33451.
Remarkably, this DMF maintains an Active status since its submission on December 26, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 25, 2019, and payment made on December 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
