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01 1Kongo Chemical Co., Ltd.

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GDUFA

DMF Review : Complete

Rev. Date : 2013-06-19

Pay. Date : 2013-06-07

DMF Number : 8960

Submission : 1991-02-04

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 8960 of Kongo Chemical Co Ltd

Looking for Drug Master Files (DMF) for 8960 of Kongo Chemical Co Ltd 1

20

Kongo Chemical Co Ltd, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is PHENIRAMINE MALEATE, with a corresponding US DMF Number 8960.

Remarkably, this DMF maintains an Active status since its submission on February 04, 1991, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 19, 2013, and payment made on June 07, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II