01 1Raks Pharma
01 1BOSENTAN MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-22
Pay. Date : 2018-04-27
DMF Number : 32757
Submission : 2018-04-30
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 BOSENTAN MONOHYDRATE, with a corresponding US DMF Number 32757.
Remarkably, this DMF maintains an Active status since its submission on April 30, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 22, 2018, and payment made on April 27, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
