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01 1Edmond Pharma

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PharmaCompass

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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2018-10-11

Pay. Date : 2018-10-04

DMF Number : 16017

Submission : 2002-06-21

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 16017 of Edmond Pharma Srl

Looking for Drug Master Files (DMF) for 16017 of Edmond Pharma Srl 1

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Edmond Pharma Srl, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is MIDODRINE HYDROCHLORIDE, with a corresponding US DMF Number 16017.

Remarkably, this DMF maintains an Active status since its submission on June 21, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 11, 2018, and payment made on October 04, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II