01 1Raks Pharma
01 1VARDENAFIL HYDROCHLORIDE TRIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-05
Pay. Date : 2016-10-03
DMF Number : 30804
Submission : 2016-10-27
Status : Active
Type : II
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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 VARDENAFIL HYDROCHLORIDE TRIHYDRATE USP, with a corresponding US DMF Number 30804.
Remarkably, this DMF maintains an Active status since its submission on October 27, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2017, and payment made on October 03, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
