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01 1PolyPeptide Group

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PharmaCompass

Looking for Drug Master Files (DMF) for 35860 of Polypeptide Laboratories Inc

Looking for Drug Master Files (DMF) for 35860 of Polypeptide Laboratories Inc 1

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Polypeptide Laboratories Inc, 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 LIRAGLUTIDE, with a corresponding US DMF Number 35860.

Remarkably, this DMF maintains an Active status since its submission on June 24, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2021, and payment made on July 15, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II