01 1PolyPeptide Group
01 1CALCITONIN (SALMON)
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-08
Pay. Date : 2015-12-21
DMF Number : 15684
Submission : 2001-10-19
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 CALCITONIN (SALMON), with a corresponding US DMF Number 15684.
Remarkably, this DMF maintains an Active status since its submission on October 19, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2016, and payment made on December 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
