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01 1PolyPeptide Group

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PharmaCompass

Looking for Drug Master Files (DMF) for 32863 of Polypeptide Laboratories Sweden Ab

Looking for Drug Master Files (DMF) for 32863 of Polypeptide Laboratories Sweden Ab 1

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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 OCTREOTIDE ACETATE, with a corresponding US DMF Number 32863.

Remarkably, this DMF maintains an Active status since its submission on June 18, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 12, 2019, and payment made on June 13, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II