01 1PolyPeptide Group
01 1DESMOPRESSIN ACETATE DRUG SUBSTANCE
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-17
Pay. Date : 2013-12-18
DMF Number : 23676
Submission : 2010-04-02
Status : Active
Type : II
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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 DESMOPRESSIN ACETATE DRUG SUBSTANCE, with a corresponding US DMF Number 23676.
Remarkably, this DMF maintains an Active status since its submission on April 02, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2014, and payment made on December 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
