01 1Raks Pharma
01 1CLIDINIUM BROMIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-18
Pay. Date : 2020-09-18
DMF Number : 35186
Submission : 2020-09-24
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 CLIDINIUM BROMIDE USP, with a corresponding US DMF Number 35186.
Remarkably, this DMF maintains an Active status since its submission on September 24, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 18, 2020, and payment made on September 18, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
