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01 1Auro Peptides Limited

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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2023-11-03

Pay. Date : 2023-09-27

DMF Number : 37793

Submission : 2023-01-27

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 37793 of Auro Peptides Ltd

Looking for Drug Master Files (DMF) for 37793 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 LIRAGLUTIDE, with a corresponding US DMF Number 37793.

Remarkably, this DMF maintains an Active status since its submission on January 27, 2023, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 03, 2023, and payment made on September 27, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II