01 1PolyPeptide Group
01 1EXENDIN-4 ACETATE (EXENATIDE)
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2013-12-13
DMF Number : 27714
Submission : 2014-01-13
Status : Active
Type : II
20
Polypeptide Laboratories Sweden Ab, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is EXENDIN-4 ACETATE (EXENATIDE), with a corresponding US DMF Number 27714.
Remarkably, this DMF maintains an Active status since its submission on January 13, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2015, and payment made on December 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
