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01 1Guilin Pharmaceutical Ltd

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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2014-03-07

Pay. Date : 2013-07-15

DMF Number : 8682

Submission : 1990-07-31

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 8682 of Guilin Pharmaceutical Co Ltd

Looking for Drug Master Files (DMF) for 8682 of Guilin Pharmaceutical Co Ltd 1

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Guilin Pharmaceutical Co Ltd, based in China, is a pharmaceutical company.

One of their notable products is BUMETANIDE USP, with a corresponding US DMF Number 8682.

Remarkably, this DMF maintains an Active status since its submission on July 31, 1990, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2014, and payment made on July 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II