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01 1Buchler GmbH

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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 : 2019-02-15

Pay. Date : 2018-08-10

DMF Number : 32527

Submission : 2018-03-23

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 32527 of Buchler Gmbh

Looking for Drug Master Files (DMF) for 32527 of Buchler Gmbh 1

20

Buchler Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is QUINIDINE GLUCONATE, with a corresponding US DMF Number 32527.

Remarkably, this DMF maintains an Active status since its submission on March 23, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 15, 2019, and payment made on August 10, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II