01 1CKD Bio Corporation
01 1CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE
01 1South Korea
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-02
Pay. Date : 2013-06-11
DMF Number : 18362
Submission : 2005-04-14
Status : Active
Type : II
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Ckd Bio Corp, based in South Korea, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 18362.
Remarkably, this DMF maintains an Active status since its submission on April 14, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 02, 2013, and payment made on June 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
