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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 : 2021-04-22

Pay. Date : 2021-03-30

DMF Number : 35791

Submission : 2021-03-30

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 35791 of Auro Peptides Ltd

Looking for Drug Master Files (DMF) for 35791 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 CALCITONIN SALMON USP, with a corresponding US DMF Number 35791.

Remarkably, this DMF maintains an Active status since its submission on March 30, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 22, 2021, and payment made on March 30, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II