01 1ST Pharma
01 1GADOBUTROL MONOHYDRATE
01 1South Korea
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-30
Pay. Date : 2021-02-26
DMF Number : 35662
Submission : 2021-02-26
Status : Active
Type : II
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St Pharm Co Ltd, based in South Korea, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is GADOBUTROL MONOHYDRATE, with a corresponding US DMF Number 35662.
Remarkably, this DMF maintains an Active status since its submission on February 26, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2021, and payment made on February 26, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
