01 1Raks Pharma
01 1METYROSINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-09
Pay. Date : 2019-05-14
DMF Number : 33862
Submission : 2019-06-13
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 METYROSINE USP, with a corresponding US DMF Number 33862.
Remarkably, this DMF maintains an Active status since its submission on June 13, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 09, 2019, and payment made on May 14, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
