01 1Raks Pharma
01 1DARUNAVIR
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-09-30
DMF Number : 30803
Submission : 2016-10-05
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 DARUNAVIR, with a corresponding US DMF Number 30803.
Remarkably, this DMF maintains an Active status since its submission on October 05, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 19, 2017, and payment made on September 30, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
