01 1Raks Pharma
01 1COLESTIPOL HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-08
Pay. Date : 2023-02-15
DMF Number : 38026
Submission : 2023-02-24
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 COLESTIPOL HYDROCHLORIDE USP, with a corresponding US DMF Number 38026.
Remarkably, this DMF maintains an Active status since its submission on February 24, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 08, 2023, and payment made on February 15, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
