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01 1Auro Peptides Limited

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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2021-01-11

Pay. Date : 2020-11-12

DMF Number : 35386

Submission : 2020-11-12

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 35386 of Auro Peptides Ltd

Looking for Drug Master Files (DMF) for 35386 of Auro Peptides Ltd 1

20

Auro Peptides Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is ETELCALCETIDE HYDROCHLORIDE, with a corresponding US DMF Number 35386.

Remarkably, this DMF maintains an Active status since its submission on November 12, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 11, 2021, and payment made on November 12, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II