01 1PolyPeptide Group
01 1LEUPROLIDE ACETATE
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2013-02-28
DMF Number : 26832
Submission : 2013-02-20
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 LEUPROLIDE ACETATE, with a corresponding US DMF Number 26832.
Remarkably, this DMF maintains an Active status since its submission on February 20, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2014, and payment made on February 28, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
