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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2019-01-29

Pay. Date : 2018-07-24

DMF Number : 32884

Submission : 2018-06-19

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 32884 of Icrom Srl

Looking for Drug Master Files (DMF) for 32884 of Icrom Srl 1

20

Icrom Srl, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METOCLOPRAMIDE HCL, with a corresponding US DMF Number 32884.

Remarkably, this DMF maintains an Active status since its submission on June 19, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2019, and payment made on July 24, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II