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01 1Auro Peptides Limited

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PharmaCompass

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BePharma
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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2021-08-30

Pay. Date : 2021-07-13

DMF Number : 36108

Submission : 2021-07-14

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 36108 of Auro Peptides Ltd

Looking for Drug Master Files (DMF) for 36108 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 GANIRELIX ACETATE, with a corresponding US DMF Number 36108.

Remarkably, this DMF maintains an Active status since its submission on July 14, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 30, 2021, and payment made on July 13, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II