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01 1Mikrochem

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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2023-02-23

Pay. Date : 2023-02-21

DMF Number : 31694

Submission : 2017-07-05

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 31694 of Mikrochem Spol Sro

Looking for Drug Master Files (DMF) for 31694 of Mikrochem Spol Sro 1

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Mikrochem Spol Sro, based in Slovakia, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is METHYLENE BLUE, with a corresponding US DMF Number 31694.

Remarkably, this DMF maintains an Active status since its submission on July 05, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 23, 2023, and payment made on February 21, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II