01 1PolyPeptide Group
01 1SEMAGLUTIDE DRUG SUBSTANCE
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-31
Pay. Date : 2023-03-27
DMF Number : 38177
Submission : 2023-08-02
Status : Active
Type : II
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Polypeptide Sa, 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 SEMAGLUTIDE DRUG SUBSTANCE, with a corresponding US DMF Number 38177.
Remarkably, this DMF maintains an Active status since its submission on August 02, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 31, 2023, and payment made on March 27, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
